Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug2490 | Placebo Wiki | 0.50 |
drug1366 | Gam-COVID-Vac Wiki | 0.42 |
drug3923 | mRNA-1273 Wiki | 0.28 |
Name (Synonyms) | Correlation | |
---|---|---|
drug899 | Convalescent plasma Wiki | 0.23 |
drug2805 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki | 0.21 |
drug4004 | placebo Wiki | 0.18 |
drug384 | BNT162b1 Wiki | 0.18 |
drug941 | Covigenix VAX-001 placebo Wiki | 0.16 |
drug1586 | IMM-101 Wiki | 0.16 |
drug3947 | multipeptide cocktail Wiki | 0.16 |
drug97 | ARCT-021 Dose 1 Wiki | 0.16 |
drug241 | Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS) Wiki | 0.16 |
drug790 | Cliniporator Wiki | 0.16 |
drug1367 | Gam-COVID-Vac Lyo Wiki | 0.16 |
drug1437 | Heparin Wiki | 0.16 |
drug385 | BNT162b2 Wiki | 0.16 |
drug454 | Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group Wiki | 0.16 |
drug383 | BNT162a1 Wiki | 0.16 |
drug581 | COVI-VAC Wiki | 0.16 |
drug457 | Biological: mRNA-1273: 50 mcg Wiki | 0.16 |
drug99 | ARCT-021 Dose 3 Wiki | 0.16 |
drug739 | ChAdOx1 nCoV-19 single dose + paracetamol Wiki | 0.16 |
drug158 | Ad5-nCoV Wiki | 0.16 |
drug1325 | Flu shot Wiki | 0.16 |
drug2936 | SARS-CoV-2 vaccine (inactivated) Wiki | 0.16 |
drug2002 | MenACWY single dose + paracetamol Wiki | 0.16 |
drug386 | BNT162b3 Wiki | 0.16 |
drug3562 | V-SARS Wiki | 0.16 |
drug3802 | convalescent plasma Wiki | 0.16 |
drug2919 | SARS-CoV-2 inactivated vaccine Wiki | 0.16 |
drug1395 | Group B (Placebo) Wiki | 0.16 |
drug740 | ChAdOx1 nCoV-19 two dose + paracetamol Wiki | 0.16 |
drug1394 | Group B (AG0302-COVID19) Wiki | 0.16 |
drug1391 | Group A (Placebo) Wiki | 0.16 |
drug2514 | Placebo Comparator Wiki | 0.16 |
drug160 | AdCOVID Wiki | 0.16 |
drug12 | 0.9% (w/v) saline Wiki | 0.16 |
drug2312 | One COVID-19 vaccine candidate (TMV-083) administration - High dose Wiki | 0.16 |
drug452 | Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki | 0.16 |
drug453 | Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki | 0.16 |
drug1921 | MMR vaccine Wiki | 0.16 |
drug2503 | Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) Wiki | 0.16 |
drug387 | BNT162c2 Wiki | 0.16 |
drug3494 | Two COVID-19 vaccine candidate (TMV-083) administrations - High dose Wiki | 0.16 |
drug456 | Biological: mRNA-1273: 100 mcg Wiki | 0.16 |
drug2278 | Observation Wiki | 0.16 |
drug367 | BCG vaccine Wiki | 0.16 |
drug2812 | Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) Wiki | 0.16 |
drug98 | ARCT-021 Dose 2 Wiki | 0.16 |
drug1583 | IIBR-100, low dose (prime) Wiki | 0.16 |
drug102 | ARCT-021 Dose Regimen 2 Wiki | 0.16 |
drug3495 | Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose Wiki | 0.16 |
drug653 | COVID19 vaccine Wiki | 0.16 |
drug1582 | IIBR-100 medium dose (prime) Wiki | 0.16 |
drug1390 | Group A (AG0302-COVID19) Wiki | 0.16 |
drug1581 | IIBR-100 low-dose (prime-boost) Wiki | 0.16 |
drug2574 | Placebo; 0.9% saline Wiki | 0.16 |
drug2001 | MenACWY prime & saline placebo boost + paracetamol Wiki | 0.16 |
drug1585 | IL-12 plasmid Wiki | 0.16 |
drug164 | Adenovirus Type-5 Vectored COVID-19 Vaccine Wiki | 0.16 |
drug2806 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Wiki | 0.16 |
drug577 | CORVax Wiki | 0.16 |
drug101 | ARCT-021 Dose Regimen 1 Wiki | 0.16 |
drug109 | AS03-adjuvanted SCB-2019 vaccine Wiki | 0.16 |
drug2254 | Normal saline 0.9% Wiki | 0.16 |
drug1937 | MVA-SARS-2-S vaccinations (days 0 & 28) Wiki | 0.16 |
drug1580 | IIBR-100 high-dose (prime) Wiki | 0.16 |
drug100 | ARCT-021 Dose 4 Wiki | 0.16 |
drug928 | Covax-19™ Wiki | 0.16 |
drug159 | AdCLD-CoV19 Wiki | 0.16 |
drug1210 | EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) Wiki | 0.16 |
drug2777 | RUTI® vaccine Wiki | 0.16 |
drug940 | Covigenix VAX-001 Wiki | 0.16 |
drug128 | AZD1222 Wiki | 0.14 |
drug2930 | SARS-CoV-2 rS/Matrix-M1 Adjuvant Wiki | 0.11 |
drug731 | ChAdOx1 nCoV-19 Wiki | 0.11 |
drug394 | Bacille Calmette-Guérin (BCG) Wiki | 0.11 |
drug4042 | rAd26-S Wiki | 0.11 |
drug2988 | Saline Placebo Wiki | 0.11 |
drug678 | CVnCoV Vaccine Wiki | 0.11 |
drug2529 | Placebo Vaccine Wiki | 0.11 |
drug3523 | UB-612 Wiki | 0.11 |
drug80 | AG0301-COVID19 Wiki | 0.11 |
drug1592 | INO-4800 Wiki | 0.09 |
drug1642 | Inactivated SARS-CoV-2 Vaccine (Vero cell) Wiki | 0.09 |
drug81 | AG0302-COVID19 Wiki | 0.09 |
drug157 | Ad26.COV2.S Wiki | 0.09 |
drug366 | BCG Vaccine Wiki | 0.08 |
drug557 | CELLECTRA® 2000 Wiki | 0.08 |
drug2985 | Saline Wiki | 0.07 |
Name (Synonyms) | Correlation | |
---|---|---|
D018352 | Coronavirus Infections NIH | 0.36 |
D007239 | Infection NIH | 0.35 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.33 |
Name (Synonyms) | Correlation | |
---|---|---|
D000257 | Adenoviridae Infections NIH | 0.29 |
D006331 | Heart Diseases NIH | 0.16 |
D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.16 |
D018746 | Systemic Inflammatory Response Syndrome NIH | 0.16 |
D014115 | Toxemia NIH | 0.16 |
D018805 | Sepsis NIH | 0.16 |
D003327 | Coronary Disease NIH | 0.16 |
D012327 | RNA Virus Infections NIH | 0.16 |
D008173 | Lung Diseases, Obstructive NIH | 0.16 |
D014777 | Virus Diseases NIH | 0.13 |
D018450 | Disease Progression NIH | 0.11 |
D011014 | Pneumonia NIH | 0.11 |
D012141 | Respiratory Tract Infections NIH | 0.08 |
D003141 | Communicable Diseases NIH | 0.07 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0006510 | Chronic pulmonary obstruction HPO | 0.16 |
HP:0006536 | Pulmonary obstruction HPO | 0.16 |
HP:0100806 | Sepsis HPO | 0.16 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002090 | Pneumonia HPO | 0.11 |
HP:0011947 | Respiratory tract infection HPO | 0.08 |
Navigate: Correlations HPO
There are 39 clinical trials
The primary objective of this study is to describe the safety and tolerability of one IM dose of AZD1222 followed by one IM dose of rAd26-S in adults ≥ 18 years of age
Description: Incidence of Serious Adverse Events (SAEs) post first dose until the study end
Measure: Incidence of Serious Adverse Events (SAEs) post first dose until the study end Time: from Day 1 until Day 180Description: Incidence of unsolicited AEs for 28 days post each dose
Measure: Incidence of unsolicited Adverse Events (AEs) for 28 days post each dose Time: from Day 1 to Day 28 and from Day 29 to Day 57Description: Incidence of local and systemic solicited AEs for 7 days post each dose
Measure: Incidence of local and systemic solicited AEs for 7 days post each dose Time: from Day 1 to Day 8 and From Day 29 to Day 36Description: Incidence of AESIs post first dose until study end (Day 180)
Measure: Incidence of Adverse events of special interest (AESIs) post first dose until study end Time: from Day 1 to Day 180Description: assessment of time course of antibody to Spike protein of one IM dose of AZD1222 followed by one IM dose of rAd26-S
Measure: assessment of time course of antibody to Spike protein of one IM dose of AZD1222 followed by one IM dose of rAd26-S Time: On Day 1 and on Day 29Description: Determination of anti-SARS-CoV-2 neutralising antibody levels in serum following one IM dose of AZD1222 followed by one IM dose of rAd26-S
Measure: Determination of anti-SARS-CoV-2 neutralising antibody levels in serum following one IM dose of AZD1222 followed by one IM dose of rAd26-S Time: On Day 1 and on day 29Description: Proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titers from day of dosing baseline value to 28 days post each dose) as measured by SARS-CoV-2 antibodies to Spike protein
Measure: Proportion of participants who have a post treatment seroresponse Time: from Day 1 (before dose) to Day 28 and from Day 29 (before dose) to Day 57Bacillus Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but has also been shown to induce protection against various infections with a viral aetiology, leading to significant reductions in morbidity and mortality. We hypothesize that BCG vaccination might be a potent preventive measure against SARS-CoV-2 infection and/or may reduce disease severity in elderly people, who are known to be at increased risk of illness and death from SARS-CoV-2 infection. Therefore, we will in this placebo-controlled adaptive multi-centre randomized controlled trial evaluate the ability of BCG to reduce hospital admission and its efficacy to improve the clinical course of SARS-CoV-2 infection in elderly people((≥ 60 years of age).
Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied
Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2
Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3. Time: Visit 3 (90 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4 Time: Visit 4 (135 +/- 5 days)Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5
Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5 Time: Visit 5 (180 +/- 5 days)Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled
Measure: Prevalence of IgG/IgM against SARS-CoV-2 Time: Screening Visit and Visit 3 (90 +/- 5 days)Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit
Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19. Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.
Measure: The impact of new cardiovascular events between the two study groups Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.
Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.
Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.
Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.
Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm
Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5 Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.
Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed
Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-SARS-2-S. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.
Description: Safety and reactogenicity will be assessed by observation, questionaire and diary. Occurence of Serious Adverse Events (SAE) will be collected throughout the entire study duration.
Measure: Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol Time: during the entire study (up to 6 months)Description: Magnitude of SARS-CoV2-specific antibody responses (ELISA and neutralization assays) monitored in an approved laboratory
Measure: Immunogenicity. Number of participants who seroconverted Time: during the entire study (up to 6 months)This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .
Description: Occurrence of adverse reactions post vaccination
Measure: Safety indexes of adverse reactions Time: within 14 days post each vaccinationDescription: Evaluate the Geometric mean titer (GMT) of IgG antibody
Measure: Immunogencity indexes of GMT Time: Day 28 post the second vaccinationDescription: Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Measure: Immunogencity indexes of neutralizing antibody Time: Day 28 post the second vaccinationDescription: Occurrence of adverse reactions post-vaccination
Measure: Safety indexes of adverse events Time: Day 0-7,0-14,0-28 post each vaccinationDescription: Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)
Measure: Safety indexes of Hematological examination measures(Hemoglobin, WBC) Time: pre-vaccination, day 4 post each vaccinationDescription: Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)
Measure: Safety indexes of Blood routine measures(ALT, AST) Time: pre-vaccination, day 4 post each vaccinationDescription: Occurrence of serious adverse events post-vaccination
Measure: Safety indexes of SAE Time: Within 6 months post the second vaccinationDescription: Evaluate the Geometric mean titer of IgG antibody
Measure: Immunogencity indexes of GMT Time: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccinationDescription: Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Measure: Immunogencity indexes of neutralizing antibody Time: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccinationDescription: Number of cell-mediated immune response against SARS-CoV-2(IL-2)
Measure: Immunogencity indexes of cellular immune Time: Day 28 post the first vaccination, pre and day 28 post the second vaccinationRandomized, double-blind, placebo controlled clinical trial of immunogenicity, safety and efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults.
Description: Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Measure: Seroconversion rate Time: 42 day, 180 dayDescription: Incidence and severity of adverse events in trial subjects within 6 months after injecting the first dose of the study drug/placebo
Measure: Incidence and severity of adverse events Time: through the study (till day 180)Description: Geometric mean virus-neutralizing antibodies titer in 500 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose
Measure: Virus-neutralizing antibody levels against the SARS-CoV-2 Time: 42 dayDescription: Geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Measure: Antibody levels against the SARS-CoV-2 glycoprotein Time: 42 day, 180 dayDescription: Percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months, as confirmed with the method of polymerase chain reaction (PCR)
Measure: Percentage of trial subjects with coronavirus disease 2019 (COVID-19) Time: through the study (till day 180)This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation
Description: Percentage of laboratory-confirmed COVID-19 cases
Measure: Incidence of laboratory-confirmed COVID-19 after the second dose Time: 14 days to 6 months after the second doseDescription: Percentage of suspected COVID-19 cases
Measure: Incidence of suspected COVID-19 cases Time: within 14 days to 6 months after the second dose.Description: Percentage of laboratory-confirmed cases (severe, critical, death)
Measure: Incidence of laboratory-confirmed cases (severe, critical and death) Time: within 14 days to 6 months after the second doseDescription: Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches
Measure: Seroconversion rate anti-S antibody IgG titer (ELISA) Time: 14 days after two doses of vaccinationDescription: Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches
Measure: Seroconversion rate anti-S antibody IgG titer (ELISA) Time: 6 months after two doses of vaccinationDescription: Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches
Measure: Seropositive rate of neutralizing antibodies Time: 14 days after two doses of vaccinationDescription: Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches
Measure: Seropositive rate of neutralizing antibodies Time: 6 months after two doses of vaccinationDescription: Number of Local reactions and systemic events
Measure: Local reaction and systemic events Time: 30 minutes to 14 days after each vaccinationDescription: Number of Local reactions and systemic events
Measure: Local reaction and systemic events occurring after the last vaccination Time: 14 days to 28 days following last vaccinationDescription: Number of any SAE occur
Measure: Serious adverse events during study Time: 6 months after the last doseGC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed for safety through week 26.
Description: Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations.
Measure: To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities. Time: 26 weeksDescription: Magnitude of IFN-γ producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations.
Measure: To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response Time: 6 weeksDescription: Detection of SARS-CoV-2 by RT-PCR in respiratory tract specimens at week 0, 1, 2, 3, and 4.
Measure: Virologic response after vaccination Time: 4 weeksDescription: Number of participants with moderate, severe or critical Covid-19 at week 6.
Measure: Clinical outcome and progression after vaccinations Time: 6 weeksThe aim of the clinical study is to determine the safety, reactogenicity and immunogenicity parameters of the EpiVacCorona vaccine in volunteers aged 18-60 years. The research tasks are to: - evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly; - evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly; - identify the development of adverse reactions to vaccine administration; - study the humoral and cellular immune responses following two doses of the EpiVacCorona vaccine.
Description: • The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 9 months post vaccination versus a placebo.
Measure: The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination Time: throughout the study, an average of 270 daysDescription: • The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA greater ≥ 4 times 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination compared with a placebo.
Measure: The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA following the vaccination compared with a placebo. Time: at days 0, 1, 14, 20, 35, 42, 90, 180, 270Description: • The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA greater than ≥ 4 times 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination, compared with a placebo.
Measure: The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo Time: at days 0, 1, 14, 20, 35, 42, 90, 180, 270Description: • The proportion of volunteers with an ex vivo cellular immune response 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination, compared with a placebo.
Measure: The proportion of volunteers with an ex vivo cellular immune response following the vaccination, compared with a placebo Time: at days 0, 1, 14, 20, 35, 42, 90, 180, 270Description: • Immediate adverse events (allergic reactions) that occur within 2 hours after vaccination and that are identified both by the clinical investigator and based on information provided by the volunteer; adverse events (local and systemic reactions) that occur within 7 days after vaccination and that are identified both by the clinical investigator and based on information provided by the volunteer; other adverse events that occur 7 days after each vaccination (from 8 to 42 days after the first vaccination, excluding the allowable interval of visits) and noted by the volunteer in the Self-observation Diary.
Measure: Incidence and type of adverse events during the study Time: throughout the study, an average of 270 daysDescription: • Incidence of serious adverse events during the study.
Measure: Incidence of serious adverse events during the study Time: throughout the study, an average of 270 daysDescription: • Cases of early termination of participation of volunteers in the study due to the development of adverse events / sever adverse events associated with the use of products under study.
Measure: Cases of early termination of the study due to the development of adverse events / sever adverse events Time: throughout the study, an average of 270 daysThe purpose of the study is to assess safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac ", a solution for intramuscular administration, with the participation of healthy volunteers Study objectives A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using single dose of each component (Stage 1). A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2). Post-vaccination immunity assessment at different time points after vaccination by: - Determination of antigen-specific antibody titer in blood serum by ELISA by comparison with baseline values before the vaccine administration and at days 14, 21, 28, and 42 after vaccination (hereinafter, the countdown comes from the first time of the vaccine administration); - Determination of virus neutralizing antibody titer before and at days 14, 28, and 42 after vaccination; - Determination of antigen-specific cellular immunity (specific T-cell immunity) before the vaccine administration and at days 14 and 28 after vaccination.
Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Measure: Changing ofantibody levels against the SARS-CoV-2 glycoprotein S in 42 days Time: at days 0,14, 21, 28, 42Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of virus neutralizing antibody titer
Measure: Changing of of virus neutralizing antibody titer Time: at days 0,14, 28, 42Description: Determination of antigen-specific cellular immunity (specific T-cell immunityin particular, IFN-gamma production or lymphoproliferation)
Measure: Changing of antigen-specific cellular immunity level Time: at days 0,14, 42This is a randomized, placebo-controlled, two center, Phase I trial in healthy adult volunteer participants consisting of two phases, an unblinded dose escalation and a double blind treatment phase to investigate the safety, tolerability and immunogenicity of a novel measles-vector based vaccine candidate against SARS-CoV-2 infection (TMV-083).
Description: Rate of solicited Adverse Event up to 14 days after each injection. Rate of unsolicited AE up to 28 days after the last injection. Rate of serious adverse events (SAEs), serious adverse reactions (SARs), suspected unexpected serious adverse reactions (SUSARs) and adverse events of special interest (AESI) all along the study period.
Measure: To assess the safety and tolerability of the COVID-19 vaccine following one or two consecutive intramuscular injections in healthy volunteers Time: Day 390Description: SARS-CoV-2 specific antibodies up to study day 390 as measured by spike protein-specific ELISA
Measure: To assess induction of SARS-CoV-2 spike protein-binding antibodies upon one or two administrations of the COVID-19 vaccine by means of ELISA up to study day 390 Time: Day 390Description: SARS-CoV-2 specific antibodies up to study day 390 for each cohort as measured by serum neutralization assay
Measure: To assess induction of SARS-CoV-2 neutralizing antibodies upon one or two administrations of the COVID-19 vaccine by means of serum neutralization assay up to study day 390 Time: Day 390Description: SARS-CoV-2 spike protein-specific cell-mediated immune response up to study day 390 induced by one or two doses as measured by intracellular staining and flow cytometry
Measure: To assess SARS-CoV-2 spike protein-specific, cell-mediated immune responses up to study day 390, induced by one or two doses of vaccine, by means of intracellular staining and flow cytometry. Time: up to Day 390Description: Occurrence of measles virus shedding as evidenced by a positive RT-PCR for saliva, nasal swab, urine, or blood sample in sentinel groups.
Measure: To assess potential measles virus shedding by means of RT-qPCR of saliva, nasal swab, urine, or blood samples in sentinel groups on day 0 and up to day 42 Time: up to Day 42Description: Measles virus antibody levels as assessed by standard ELISA assays on day 0 and day 28.
Measure: To assess the anti-measles antibody levels at baseline and on day 28 by ELISA Time: up to Day 28Description: SARS-CoV-2 N protein specific antibody up to study day 390 as measured by ELISA to differentiate the response to the COVID-19 vaccine from infection
Measure: To assess the natural exposure of the subjects to SARS-CoV-2 during the duration of the trial by means of N protein-specific ELISA Time: Day 390Description: Occurrence of confirmed COVID-19 (i.e. asymptomatic, paucisymptomatic or symptomatic) cases in the study participant all along the study period
Measure: To assess the occurrence of COVID-19 cases in study participants all along the duration of the study Time: Day 390the purpose of this study: to evaluate the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", a lyofilizate for preparing solution for intramuscular administration, at various times after vaccination in healthy adult volunteers.
Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Measure: The changing of antibody levels against the SARS-CoV-2 glycoprotein S at 42 days Time: at days 0, 14, 21, 28, 42Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of virus neutralizing antibody titer
Measure: The changing of virus neutralizing antibody titer Time: at days 0, 14, 28, 42Description: Determination of antigen-specific cellular immunity (specific T-cell immunity, in particular, IFN-gamma production or lymphoproliferation)
Measure: The changing of antigen-specific cellular immunity level Time: at days 0, 14, 28This trial has two parts. Part A, a dose finding part, with three dose escalation cohorts, one dose de-escalation cohort, three dose refinement cohorts, and up to three optional cohorts in older subjects. Part B, a part with expansion cohorts with dose levels which are selected using data generated in Part A. The vaccine BNT162b3 will be administered using a Prime/Boost (P/B) regimen.
Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.
Measure: Functional antibody responses. Time: up to 365 days following dose administrationDescription: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.
Measure: Fold increase in functional antibody titers. Time: up to 365 days following dose administrationDescription: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.
Measure: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline. Time: up to 365 days following dose administrationThis is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.
This study is a phase I /II adaptive clinical trial to evaluate the safety, tolerability and the Immunogenicity of Ad5-nCoV in healthy adults from 18 to <55 and 65 to <85 years of age,with the randomized, observer-blind, dose-escalation design
Description: The occurrence of Solicited AE in all groups within 0-6 days after each vaccination;
Measure: Incidence of the Solicited AE in all groups Time: 0-6 days after each vaccinationDescription: The occurrence of Unsolicited AE in all groups within 0-28 days after each vaccination.
Measure: Incidence of Unsolicited AE in all groups Time: 0-28 days after each vaccinationDescription: The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.
Measure: Incidence of Serious adverse events (SAE) in all groups Time: 6 months after the final vaccinationDescription: Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 measured on Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method);
Measure: Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 (ELISA method); Time: Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Seroconversion rate (%of subjects with 4-fold or greater increase in antibody level) of the IgG antibody against SARS-CoV-2 measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method );
Measure: Seroconversion rate of the IgG antibody against SARS-CoV-2(ELISA method ) Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2 measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method);
Measure: Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2(ELISA method); Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2 measured on Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group (Pseudo-viral neutralization assay)
Measure: Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay) Time: Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group(Pseudo-viral neutralization assay);
Measure: Seroconversion rate of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay) Time: Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 measured on Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (Pseudo-viral neutralization assay)
Measure: Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 (Pseudo-viral neutralization assay) Time: Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector measured on Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group;
Measure: Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector Time: Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group
Measure: Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot
Measure: cellular immune response by ELISpot Time: on Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose groupDescription: The positive rate of IFN-γ, TNF-α, and IL-2 expressed by CD4+ and CD8+ T lymphocytes stimulated by S protein overlapping peptide library detected by Intracellular Cytokine Staining (ICS);
Measure: cellular immune response by ICS Time: Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose groupSafety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with COVID-19. Healthy, at least 20, volunteers will be monitored for signs of adverse events. Their PBMC will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.
Description: Routine laboratory complete blood cell count at pre- and post-treatment periods by automated CBC counter Routine laboratory complete blood count Routine clinical laboratory CBC parameters at pre- and post-treatment periods
Measure: Effect on CBC as per CTCAE v4.0 Time: 15 DaysDescription: Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer
Measure: Effect on biochemistry parameters as per CTCAE v4.0 Time: 15 DaysDescription: Clinical well-being assessed by CTCAE v4.0
Measure: Lack of adverse events as per CTCAE v4.0 Time: 15 daysThis study is a global multicenter, randomized, double-blind, placebo -controlled, adaptive designed phase Ⅲ clinical trial, in order to evaluate the efficacy, safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years old and above.
Description: The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease
Measure: Incidence of COVID-19 cases Time: day 28 to 12 months post vaccinationDescription: Evaluate the incidence of severe adverse events (SAE)
Measure: Incidence of SAE Time: Within 12 monthsDescription: Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection
Measure: Incidence of severe COVID-19 cases Time: Day 14 to 12 months post vaccinationDescription: Incidence of solicited adverse reactions within 7 days after vaccination, in a subset
Measure: Incidence of solicited adverse reactions Time: Day 0-7 post vaccinationDescription: Incidence of unsolicited adverse events within 28 days after vaccination in a subset
Measure: Incidence of unsolicited adverse events Time: Day 0-28 post vaccinationDescription: The seroconversion rate of S-RBD IgG antibody post vaccination
Measure: Immunogencity of S-RBD IgG antibody (ELISA method) Time: Day 28 post vaccinationDescription: The seroconversion rate of neutralizing antibody
Measure: Immunogencity of neutralizing antibody Time: Day 28 post vaccinationDescription: Number of cell-mediated immune response against SARS-CoV-2
Measure: Cell-mediated immune profile Time: Day 28 post vaccinationA novel betacoronavirus, SARS-CoV-2, is spreading rapidly throughout the world. A large epidemic in South Africa may overwhelm available hospital capacity and healthcare resources which would be worsened by absenteeism of healthcare workers and other frontline staff (HCW). Strategies to prevent morbidity and mortality of HCW are desperately needed to safeguard continuous patient care. Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis (TB), with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, with reported morbidity and mortality reductions as high as 70%. We hypothesize that a BCG vaccination may reduce the morbidity and mortality of healthcare workers during the COVID-19 outbreak in South Africa.
Description: To compare the incidence of HCWs hospitalized due to COVID-19 per arm.
Measure: Incidence of HCWs hospitalized due to COVID-19 per arm Time: 52 weeksDescription: To determine the incidence of SARS-CoV-2 infection in HCW by molecular or serological testing (as available) at entry, 10, 26 and/or 52 weeks.
Measure: Incidence of SARS-CoV-2 infection per arm Time: 52 weeksDescription: To compare the incidence of symptoms of upper respiratory tract infection per arm.
Measure: Incidence of upper respiratory tract infections per arm Time: 52 weeksDescription: To compare the number of days of (unplanned) absenteeism because of documented SARS-CoV-2 infection, COVID-19 or any reason per arm.
Measure: Days of unplanned absenteeism due to COVID-19 or any reason per arm Time: 52 weeksDescription: To compare the incidence of hospitalization of HCW for any reason per arm.
Measure: Incidence of hospitalization for any reason per arm Time: 52 weeksDescription: To compare the incidence of intensive care admission of HCW due to COVID-19 or any reason per arm.
Measure: Incidence of intensive care unit admission per arm Time: 52 weeksDescription: To compare the incidence of death of HCW due to COVID-19 or any reason per arm.
Measure: Incidence of death per arm Time: 52 weeksDescription: To describe the prevalence of latent TB infection as determined by interferon gamma release assay (IGRA) at enrolment and at week 52.
Measure: Prevalence of latent TB infection Time: 52 weeksDescription: To compare the incidence of active TB of HCW per arm.
Measure: Incidence of active TB per arm Time: 52 weeksDescription: To compare the effect of latent TB infection on morbidity and mortality of HCW due to COVID-19 per arm. The risk of morbidity and mortality of latent TB infected individuals is not known, we will examine whether there is a higher risk of disease severity and poor outcomes in this group.
Measure: Compare the effect of latent TB on morbidity and mortality due to COVID-19 per arm Time: 52 weeksDescription: To compare the incidence of grade 2 or higher adverse events and vaccination site reactions per arm.
Measure: Incidence of treatment related adverse events Time: 52 weeksThis is a phase I/II, placebo-controlled, randomized, observer-blind, dose ranging adaptive clinical trial in males and non-pregnant females, 18 to <55 and 65 to <85 years of age, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, immunogenicity and efficacy of Covigenix VAX-001 manufactured by Entos Pharmaceuticals.
Description: Frequency and Grade (mild, moderate, severe, potentially life-threatening; Gr. 1-4, respectively) of solicited injection site and systemic adverse events and unsolicited systemic adverse events
Measure: Safety of a 2-dose regimen of VAX-001 when doses are given 14 days apart Time: Up to Day 42Description: Adverse hematology /clinical chemistry parameter changes (mild, moderate, severe, or life-threatening; Gr. 1-4, respectively)
Measure: Mean change from baseline in safety laboratory measures Time: Days 0-42Description: Frequency of serious AEs
Measure: Frequency of treatment-emergent Serious Adverse Events (SAE) throughout the study and up to 6 months post-second dose immunization (Day 196). Time: Days 0-196Description: Percent seroconversion post second dose as measured by ELISA
Measure: Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by IgG ELISA Time: Up to Day 196Description: Geometric mean of antibody titers measured by pseudo-viral neutralization assay.
Measure: Geometric mean neutralizing antibody titers against pseudo-virion after one and two doses Time: Up to Day 196Description: Seroconversion as measured by pseudo-viral neutralization
Measure: Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by pseudo-viral neutralization assay. Time: up to Day 196Description: Maintenance of antibody titers up to Six months post second dose
Measure: Persistence of IgG antibody titers as measured by ELISA and neutralizing antibody titers measured by pseudo-virion neutralization assay, six months after the second vaccine dose Time: Up to Day 196Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Description: Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)
Measure: percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose Time: through the whole study, an average of 180 daysDescription: Assess the efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus compared to placebo, based on the severity of the clinical course of COVID-19
Measure: the severity of the clinical course of COVID-19 Time: through the whole study, an average of 180 daysDescription: Assess the immunogenicity of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the geometric mean titer of SARS-CoV-2 glycoprotein-specific antibodies
Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S Time: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first doseDescription: Incidence of adverse events in trial subjects compared to placebo
Measure: Incidence of adverse events in trial subjects Time: through the whole study, an average of 180 daysDescription: Severity of adverse events in trial subjects compared to placebo
Measure: Severity of adverse events in trial subjects Time: through the whole study, an average of 180 daysThis is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in healthy adults aged 18 to 30 years. Approximately 48 participants will be enrolled into 1 of 3 dose groups (low, medium, high). Within each of these dose groups, participants will be assigned randomly to receive either 2 doses of COVI-VAC 28 days apart, 2 doses of placebo (saline), or 1 dose of COVI-VAC and 1 dose of placebo. COVI-VAC or placebo is administered by drops into each nostril. Neither the participants nor the researchers will know whether COVI-VAC or placebo has been received. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 14 days after each dose. Safety laboratory tests, physical exams, ECGs, and a chest X-ray will also be performed, and peak expiratory flow and vital signs will be measured. Adverse events and medication use will be recorded. Blood samples and intranasal samples will be collected to assess the immune response from the vaccine.
Description: Percentage of subjects with reactogenicity events
Measure: Reactogenicity Time: 14 days after each doseDescription: Percentage of subjects with adverse events
Measure: Adverse events Time: Days 1 through 57Description: Percentage of subjects with serious adverse events
Measure: Serious adverse events Time: Days 1-400Description: IgG titre measured by ELISA in serum collected on Days 1, 15, 29, 43, 57, 120, 210, and 400
Measure: IgG titre Time: Days 1, 15, 29, 43, 57, 120, 210, and 400Description: Neutralising antibody level measured by microneutralisation assay in serum
Measure: Neutralizing antibody titre Time: Days 1, 15, 29, 43, 57, 120, 210, and 400Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Description: Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)
Measure: percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose Time: through the whole study, an average of 180 daysDescription: Assess the efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus compared to placebo, based on the severity of the clinical course of COVID-19
Measure: the severity of the clinical course of COVID-19 Time: through the whole study, an average of 180 daysDescription: Assess the immunogenicity of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the geometric mean titer of SARS-CoV-2 glycoprotein-specific antibodies
Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S Time: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first doseDescription: Describe the strength of cell-mediated immune response induced by the use of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo
Measure: Changing of antigen-specific cellular immunity level Time: the drug administration day before injecting the first dose of the study drug/placebo and 28±2 days after the first doseDescription: Geometric mean virus-neutralizing antibodies titer
Measure: Changing of of virus neutralizing antibody titer Time: the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first doseDescription: Incidence of adverse events in trial subjects compared to placebo
Measure: Incidence of adverse events in trial subjects Time: through the whole study, an average of 180 daysDescription: Severity of adverse events in trial subjects compared to placebo
Measure: Severity of adverse events in trial subjects Time: through the whole study, an average of 180 daysDescription: Percentage of study subjects with antibodies to the N-protein of the SARS - CoV-2 virus that appeared after vaccination
Measure: estimation of the proportion of study subjects with antibodies to the N-protein of the virus SARS-CoV-2 Time: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first doseThe purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age
Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days Time: at days 0, 21, 28, 42Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of virus neutralizing antibody titer
Measure: Changing of of virus neutralizing antibody titer Time: at days 0, 28, 42Description: Determination of antigen-specific cellular immunity
Measure: Changing of antigen-specific cellular immunity level Time: Time Frame: at days 0,28This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. One hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.
Description: Seroconversion is defined as a 4-fold change in antibody titer from baseline
Measure: Percentage of subjects who seroconverted Time: Day 1 to Day 57SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.
Description: The primary outcome measure is the development of COVID19 infection. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of Covid-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert. defined as number of new cases during the 6 month time period
Measure: Incidence of COVID 19 Infection Time: 6 monthsDescription: The secondary outcome measure is disease severity calculated using the Covid Severity Scale Scoring of 0 -10. A score of 10 is worse and a score of 0 is best. Disease severity score will be based on the level of care required for individuals who test positive for COVID19 as follows: non-hospital-based care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died. Additional WHO criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis and septic shock.
Measure: Disease Severity Time: up to 6 monthsThis is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS CoV 2 RNA vaccine candidates against COVID 19 and the efficacy of 1 candidate: - As a 2-dose (separated by 21 days) schedule; - At various different dose levels in Phase 1; - In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for evaluation in Phase 2/3 is BNT162b2 (mid-dose). Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.
Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Measure: Percentage of participants in Phase 1 reporting local reactions Time: For 7 days after dose 1 and dose 2Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Measure: Percentage of participants in Phase 1 reporting systemic events Time: For 7 days after dose 1 and dose 2Description: As elicited by investigational site staff
Measure: Percentage of participants in Phase 1 reporting adverse events Time: From dose 1 through 1 month after the last doseDescription: As elicited by investigational site staff
Measure: Percentage of participants in Phase 1 reporting serious adverse events Time: From dose 1 through 6 months after the last doseDescription: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values Time: 1 day after dose 1Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values Time: 7 days after dose 1Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values Time: 7 days after dose 2Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments Time: Between baseline and 1 day after dose 1Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments Time: Between baseline and 7 days after dose 1Description: As measured at the central laboratory
Measure: Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments Time: Between before dose 2 and 7 days after dose 2Description: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions Time: For 7 days after dose 1 and dose 2Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events Time: For 7 days after dose 1 and dose 2Description: As elicited by investigational site staff
Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events Time: From dose 1 through 1 month after the last doseDescription: As elicited by investigational site staff
Measure: In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events Time: From dose 1 through 6 months after the last doseDescription: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions Time: For 7 days after dose 1 and dose 2Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Measure: In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events Time: For 7 days after dose 1 and dose 2Description: As elicited by investigational site staff
Measure: Percentage of participants in Phase 2/3 reporting adverse events Time: From dose 1 through 1 month after the last doseDescription: As elicited by investigational site staff
Measure: Percentage of participants in Phase 2/3 reporting serious adverse events Time: From dose 1 through 6 months after the last doseDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: As elicited by investigational site staff
Measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events Time: From dose 1 through 1 month after the last doseDescription: As elicited by investigational site staff
Measure: Percentage of participants 12-15 years of age in Phase 3 reporting adverse events Time: From dose 1 through 6 months after the last doseDescription: Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
Measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions Time: For 7 days after dose 1 and dose 2Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
Measure: In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events Time: For 7 days after dose 1 and dose 2Description: As measured at the central laboratory
Measure: In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point Time: Through 2 years after the final doseDescription: As measured at the central laboratory
Measure: In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels Time: Through 2 years after the final doseDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 7 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: Per 1000 person-years of follow-up
Measure: Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination Time: From 14 days after the second dose of study intervention to the end of the study, up to 2 yearsDescription: As measured at the central laboratory
Measure: GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age) Time: 1 month after the second doseThis study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
Description: Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after each vaccination
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: Week 1 through Week 9Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
Measure: Immunogenicity Time: Weeks 3, 5, 7, 9The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.
Description: Clinical signs indicative of severe COVID-19 as predefined for the study.
Measure: Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of mRNA-1273 Time: Day 29 (second dose) up to Day 759 (2 years after second dose)Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 Infection as predefined for the study.
Measure: Number of Participants with a First Occurrence of Either COVID-19 or SARS-CoV-2 Infection regardless of symptomatology or Severity Starting 14 Days after Second Dose of mRNA-1273 or Placebo Time: Day 29 (second dose) up to Day 759 (2 years after second dose)]Description: Clinical signs indicative of secondary case definition of COVID-19 as predefined for the study.
Measure: Number of Participants with a Secondary Case Definition of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo Time: Day 29 (second dose) up to Day 759 (2 years after second dose)Description: Clinical signs indicative of COVID-19 as predefined for the study.
Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of mRNA-1273 or Placebo Time: Day 1 (first dose) up to Day 759 (2 years after second dose)Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.
Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo regardless of evidence of prior SARS-CoV-2 Infection Time: Day 29 (second dose) up to Day 759 (2 years after second dose)Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.
Measure: Number of Participants with a First Occurrence of SARS-CoV-2 Infection in the Absence of Symptoms Defining COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo Time: Day 29 (second dose) up to Day 759 (2 years after second dose)The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety and reactogenicity of a single dose level of mRNA-1273 vaccine administered in 2 doses 28 days apart to an adolescent population.
Description: Acceptable serum Ab threshold as predefined for the study.
Measure: Number of Participants Who have Reached the Acceptable Threshold for the Serum Ab Level at Day 57 Time: Day 57 (28 days after second dose)Description: Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.
Measure: Number of Participants with a SARS-CoV-2 Infection Starting on Day 57 Time: Day 57 up to Day 394Description: Clinical signs indicative of COVID-19 as predefined for the study.
Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo Time: Day 29 (second dose) up to Day 394 (1 year after second dose)This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy adult volunteers.
Description: Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after each vaccination
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: Week 1 through Week 9Description: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Measure: Immunogenicity Time: Weeks 3, 5, 7, 9This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 SARS-COV-2 vaccine in adults 18 years of age or older.
Description: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer either from below the limit of detection (LOD) or lower limit of quantification (LLOQ) to equal to or above LOD or LLOQ, or a 4-times higher titer in participants with pre-existing nAb titers.
Measure: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer Time: Through 1 year post last vaccinationThis study will assess the safety, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers.
Description: Frequency and severity of each adverse event solicited local and systemic AEs from the first vaccination to 4 weeks after the second vaccination
Measure: Incidence of Treatment-Emergent Adverse Events Time: Group A: 6 weeks Group B: 8 weeksDescription: Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
Measure: Immunogenicity Time: Group A: Week 7 Group B: Week 9The SARS-CoV-2 virus is responsible for the COVID-19 pandemic. The pandemic emerged from Wuhan Province in China in December 2019 and was declared by the WHO Director-General a Public Health Emergency of International Concern on 30 January 2020. In this study, a vaccine developed by IIBR for SARS-CoV-2 virus will be assessed for its safety and potential efficacy in volunteers. The study is comprised of two phases, a dose-escalation phase (phase I) during which subjects (18-55 years old) will be randomly allocated to receive a single administration of IIBR-100 100 at low, mid or high dose or saline or two administrations of IIBR-100 at low dose, or saline, 28 days apart. Based on results obtained during phase I, and cumulative phase I data review, the expansion phase (phase II) will begin, during which larger cohorts as well as elderly age subjects will be randomly allocated to receive a single administration of IIBR-100 at low, mid or high dose or saline, or two administrations of IIBR-100 at low dose (prime-boost) or saline, 28 days apart. The subjects will be followed for a period of up to 12 months post last vaccine administration to assess the safety and efficacy of the vaccine.
Description: Solicited events for 7 days after vaccination. Unsolicited events through 28 days after vaccination. SAEs 365 days after last vaccination New Onset Chronic Medical Condition (NOCMC) or Medically Attended AE (MAAE) 365 days after last vaccination.
Measure: Phase I and II - The number, grade and percentage of study participants who experience any study injection-associated AEs or SAEs. Time: 365 days post last vaccinationDescription: Immunogenicity will be evaluated at the following days: 0, 7±2d, 14±2d, 28±4d, 56±5d, 84±4d, 168±14d and 365±14d after the first vaccination for single-dose groups (prime), and at days 0, 14±2d, 28±4d, 35±4d, 42±4d, 56±5d, 84±4d, 112±14d, 196±14d and 393±14d for the prime-boost groups
Measure: Phase I and II - IIBR-100 Immunogenicity as determined by GMT, GMFR, Seroconversion rates of the neutralizing antibody titers to SARS-CoV-2 at baseline (day 0) and throughout the study Time: 365 days post last vaccinationDescription: Immunogenicity will be evaluated at the following days: 0, 7±2d, 14±2d, 28±4d, 56±5d, 84±4d, 168±14d and 365±14d after the first vaccination for single-dose groups (prime), and at days 0, 14±2d, 28±4d, 35±4d, 42±4d, 56±5d, 84±4d, 112±14d, 196±14d and 393±14d for the prime-boost groups
Measure: Phase I and II - IIBR-100 immunogenicity as determined by GMT, GMFR, Seroconversion rates of the binding antibody titers to SARS-CoV-2 at baseline (day 0) and throughout the study Time: 365 days post last vaccinationDescription: Cellular immunity will be assessed at the following days: 0, 28±4d, 56±5d, 84±4d, 168±14d and 365±14d for single dose groups and at days 0, 56±5d, 84±4d, 112±14d, 196±14d and 393±14d for the prime-boost groups.
Measure: Phase I and II - Cellular immunity as assessed by ELISPOT and ELISA. Time: 365 days post last vaccinationDescription: immunogenicity as determined by GMT, GMFR and seroconversion rates of the neutralizing, and binding, antibody titers to SARS-CoV-2 at 3, 6, 9 and 12 months after first vaccination, in a sub-group of subjects.
Measure: phase I and II - Evaluate the kinetics of antibody decline based on temporal sub-group analyses (at 3, 6, 9, 12 months post first vaccination) Time: 365 daysA study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
Description: Counts and percentages of subjects with local and systemic events
Measure: Reactogenicity Time: For 7 days after vaccinationDescription: Counts and percentages of subjects with AEs
Measure: Adverse Events (AEs) Time: Day 1 to Day 57The trial has two parts: Part A is for dose ranging with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older subjects. Part B is dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen.
Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 21±2 days after the prime immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 21 days following dose administrationDescription: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 28±4 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.
Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE): Time: 28 days following dose administrationDescription: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): Time: up to 162 days following dose administrationDescription: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): Time: up to 162 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): Time: up to 162 days following dose administrationDescription: Functional antibody responses at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationDescription: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Measure: For BNT162c2 (SD): Time: up to 183 days following dose administrationThere is currently no treatment available for COVID-19, the acute respiratory illness caused by the novel SAR-CoV-2. Convalescent plasma from patients who have recovered from COVID-19 that contains antibodies to the virus is a potential therapy. On March 25th, 2020, the FDA approved the use of convalescent plasma under the emergency investigational new drug (eIND) category. Randomized trials are needed to determine the efficacy and safety of COVID-19 convalescent plasma for acute COVID-19 infection. The objective of the CONCOR-1 trial is to determine the efficacy of transfusion of COVID-19 convalescent plasma to adult patients admitted to hospital with COVID-19 infection at decreasing the frequency of in-hospital mortality in patients hospitalized for COVID-19. It is hypothesized that treating hospitalized COVID-19 patients with convalescent plasma early in their clinical course will reduce the risk of death, and that other outcomes will be improved including risk of intubation, and length of ICU and hospital stay. This pan-Canadian clinical trial has the potential to improve patient outcomes and reduce the burden on health care resources including reducing the need for ICU beds and ventilators.
Description: Endpoint of the need for intubation or patient death in hospital
Measure: Intubation or death in hospital Time: Day 30Description: Endpoint of the need for intubation before 30 days
Measure: Need for Intubation Time: Day 30Description: Time in hours to intubation from randomization
Measure: Time to intubation Time: Day 30Description: Endpoint of the number of days off ventilator at 30 days
Measure: Ventilator-free days Time: Day 30Description: In-hospital death censored at 90 days
Measure: In-hospital death Time: 90 daysDescription: Time to in-hospital death at 90 days
Measure: Time to in-hospital death Time: Day 90Description: Death at 30 days
Measure: Death at 30 days Time: 30 daysDescription: Date of intensive care unit admission (first date and total number of days)
Measure: Length of stay in intensive care unit (ICU) Time: Day 30Description: Date of hospital admission (first date and total number of days)
Measure: Length of stay in hospital Time: Day 30Description: First date on ECMO and total number of days
Measure: Need for extracorpeal membrane oxygenation (ECMO) Time: Day 30Description: Need for renal replacement therapy
Measure: Need for renal replacement therapy Time: Day 30Description: New myocarditis
Measure: Development of myocarditis Time: Day 30Description: Transfusion-associated adverse events, Grade 3 and 4 serious adverse events, and cumulative incidence of Grade 3 and 4 adverse events and serious adverse events (using medDRA)
Measure: Adverse events and serious adverse events Time: Day 30Description: CCP transfusion-associated adverse events (AE)
Measure: CCP transfusion-associated adverse events (AE) Time: 30 daysThere is currently no treatment available for COVID-19, the acute respiratory illness caused by the novel SAR-CoV-2. Convalescent plasma from patients who have recovered from COVID-19 that contains antibodies to the virus is a potential therapy. On March 25th, 2020, the FDA approved the use of convalescent plasma under the emergency investigational new drug (eIND) category. Randomized trials are needed to determine the efficacy and safety of COVID-19 convalescent plasma for acute COVID-19 infection. The objective of the CONCOR-1 trial is to determine the efficacy of transfusion of COVID-19 convalescent plasma to adult patients admitted to hospital with COVID-19 infection at decreasing the frequency of in-hospital mortality in patients hospitalized for COVID-19. It is hypothesized that treating hospitalized COVID-19 patients with convalescent plasma early in their clinical course will reduce the risk of death, and that other outcomes will be improved including risk of intubation, and length of ICU and hospital stay. WCM is a U.S. sub-site to this pan-Canadian clinical trial (NCT04348656) which has the potential to improve patient outcomes and reduce the burden on health care resources including reducing the need for ICU beds and ventilators.
Description: Endpoint of the need for intubation or patient death in hospital
Measure: Intubation or death in hospital Time: Day 30Description: Endpoint of the need for intubation before 30 days
Measure: Need for Intubation Time: Day 30Description: Time in hours to intubation from randomization
Measure: Time to intubation Time: Day 30Description: Endpoint of the number of days off ventilator at 30 days
Measure: Ventilator-free days Time: Day 30Description: In-hospital death censored at 90 days
Measure: In-hospital death Time: 90 daysDescription: Time to in-hospital death at 90 days
Measure: Time to in-hospital death Time: Day 90Description: Death at 30 days
Measure: Death at 30 days Time: 30 daysDescription: Date of intensive care unit admission (first date and total number of days)
Measure: Length of stay in intensive care unit (ICU) Time: Day 30Description: Date of hospital admission (first date and total number of days)
Measure: Length of stay in hospital Time: Day 30Description: First date on ECMO and total number of days
Measure: Need for extracorpeal membrane oxygenation (ECMO) Time: Day 30Description: Need for renal replacement therapy
Measure: Need for renal replacement therapy Time: Day 30Description: New myocarditis
Measure: Development of myocarditis Time: Day 30Description: Transfusion-associated adverse events, Grade 3 and 4 serious adverse events, and cumulative incidence of Grade 3 and 4 adverse events and serious adverse events (using medDRA)
Measure: Adverse events and serious adverse events Time: Day 30Description: CCP transfusion-associated adverse events (AE)
Measure: CCP transfusion-associated adverse events (AE) Time: 30 daysThis is a two-center, randomized, placebo-controlled pilot study of anti-SARS-CoV-2 equine immunoglobulin fragments F(ab')2 (INOSARS) to evaluate safety and preliminary efficacy in the treatment of hospitalized COVID-19 patients. Clinical improvement at 28 days from the start of treatment will be evaluated.
Description: The primary endpoint is the proportion of patients with clinical improvement at 28 days after treatment. Clinical improvement is defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale. Scale categories as follows: 1 = not hospitalized; 2 = not hospitalized with limitation of activities and/or oxygen requirement; 3 = hospitalized not requiring supplemental oxygen and not requiring active medical care, 4 = hospitalized requiring active medical care without requiring oxygen supplementation; 5 = hospitalized requiring oxygen supplementation; 6 = hospitalized requiring high-flow oxygen or non-invasive mechanical ventilation; 7 = hospitalized requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8 = death.
Measure: Proportion of patients with improvement in clinical status Time: 28 daysDescription: Time from the day of treatment until the first day with clinical improvement, defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale.
Measure: Time to clinical improvement Time: 28 daysDescription: Proportion of participant death or non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation requirement.
Measure: Proportion of patients that reach a score of 6, 7 or 8 in the NIAID 8-point ordinal scale Time: 28 daysDescription: Measured in days
Measure: Duration of hospitalization Time: 28 daysDescription: Proportion of patients that have a negative polymerase chain reaction assay for SARS-CoV-2 at 72 hrs from start of treatment.
Measure: SARS-CoV-2 PCR negativization rate Time: 3 daysDescription: Proportion of patients with clinical improvement at day 7. Clinical improvement is defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale
Measure: Proportion of patients with clinical improvement at day 7 Time: 7 daysDescription: Proportion of patients that present within 24 hours of treatment with immediate adverse events defined as: skin rash and/or respiratory findings (dyspnea, wheezing, bronchospasm, hypoxia) and/or circulatory compromise (reduction of blood pressure or associated symptoms, i.e. syncope).
Measure: Proportion of patients with immediate adverse events (< 24 hours) Time: 24 hoursDescription: Proportion of patients that present events associated with serum sickness (type 3 hypersensitivity), vasculitis, glomerulonephritis, arthritis.
Measure: Proportion of patients with late adverse events (1 - 28 days) Time: 28 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports