Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2805 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki | 0.32 |
| drug2490 | Placebo Wiki | 0.27 |
| drug1366 | Gam-COVID-Vac Wiki | 0.27 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3499 | Two dose MenACWY vaccine min. 4 weeks apart Wiki | 0.24 |
| drug3947 | multipeptide cocktail Wiki | 0.24 |
| drug790 | Cliniporator Wiki | 0.24 |
| drug2633 | Preservative-free saline Wiki | 0.24 |
| drug84 | AKS-452 Wiki | 0.24 |
| drug192 | AlloStim Wiki | 0.24 |
| drug739 | ChAdOx1 nCoV-19 single dose + paracetamol Wiki | 0.24 |
| drug1652 | Information Wiki | 0.24 |
| drug158 | Ad5-nCoV Wiki | 0.24 |
| drug2936 | SARS-CoV-2 vaccine (inactivated) Wiki | 0.24 |
| drug2002 | MenACWY single dose + paracetamol Wiki | 0.24 |
| drug2919 | SARS-CoV-2 inactivated vaccine Wiki | 0.24 |
| drug1395 | Group B (Placebo) Wiki | 0.24 |
| drug740 | ChAdOx1 nCoV-19 two dose + paracetamol Wiki | 0.24 |
| drug1394 | Group B (AG0302-COVID19) Wiki | 0.24 |
| drug1391 | Group A (Placebo) Wiki | 0.24 |
| drug3497 | Two dose ChAdOx1 nCoV-19/Covishield 0.5mL Wiki | 0.24 |
| drug2003 | MenACWY vaccine Wiki | 0.24 |
| drug364 | BCG Wiki | 0.24 |
| drug653 | COVID19 vaccine Wiki | 0.24 |
| drug1390 | Group A (AG0302-COVID19) Wiki | 0.24 |
| drug736 | ChAdOx1 nCoV-19 0.5mL prime plus boost Wiki | 0.24 |
| drug2001 | MenACWY prime & saline placebo boost + paracetamol Wiki | 0.24 |
| drug3498 | Two dose MenACWY vaccine Wiki | 0.24 |
| drug1585 | IL-12 plasmid Wiki | 0.24 |
| drug164 | Adenovirus Type-5 Vectored COVID-19 Vaccine Wiki | 0.24 |
| drug577 | CORVax Wiki | 0.24 |
| drug734 | ChAdOx1 nCoV-19 (qPCR) Wiki | 0.24 |
| drug3987 | oral polio vaccine + information Wiki | 0.24 |
| drug733 | ChAdOx1 nCoV-19 (Abs 260) + 2.2x10^10vp (qPCR) boost Wiki | 0.24 |
| drug732 | ChAdOx1 nCoV-19 (Abs 260) Wiki | 0.24 |
| drug3422 | Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine Wiki | 0.24 |
| drug1937 | MVA-SARS-2-S vaccinations (days 0 & 28) Wiki | 0.24 |
| drug3496 | Two dose ChAdOx1 nCoV-19/Covishield 0.25mL & 0.5mL Wiki | 0.24 |
| drug4042 | rAd26-S Wiki | 0.17 |
| drug80 | AG0301-COVID19 Wiki | 0.17 |
| drug119 | AV-COVID-19 Wiki | 0.14 |
| drug81 | AG0302-COVID19 Wiki | 0.14 |
| drug3923 | mRNA-1273 Wiki | 0.14 |
| drug384 | BNT162b1 Wiki | 0.14 |
| drug3574 | VPM1002 Wiki | 0.14 |
| drug385 | BNT162b2 Wiki | 0.12 |
| drug367 | BCG vaccine Wiki | 0.12 |
| drug128 | AZD1222 Wiki | 0.11 |
| drug2985 | Saline Wiki | 0.11 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000257 | Adenoviridae Infections NIH | 0.32 |
| D007239 | Infection NIH | 0.23 |
| D018352 | Coronavirus Infections NIH | 0.15 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 18 clinical trials
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 is a study to test a new vaccine (Covax-19) against COVID-19. COVID-19 is a potentially deadly disease that is caused by a new strain of coronavirus called SARS-CoV-2. To date, SARS-CoV-2 has infected over 4 million people worldwide resulted in the deaths of over three hundred thousand people.
Description: Incidence of Adverse Events 1 week post immunisation
Measure: Incidence of Adverse Events Time: 1 weeks post immunisationDescription: COVID19 neutralizing antibody titers post immunisation
Measure: COVID19 neutralizing antibody titers Time: 2 weeks post second immunisationDescription: Frequency of COVID19 spike specific T cells 3 weeks post second immunisation
Measure: COVID19 T cell immunogenicity Time: 3 weeks post second immunisationDescription: COVID19 spike specific antibody titers 6 months post second immunisation
Measure: Durability of antibody response Time: 6 months post immunisationThe 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .
Description: Occurrence of adverse reactions post-vaccination
Measure: Safety indexes of adverse reactions Time: 0-7 days post-vaccinationDescription: Occurrence of adverse events post-vaccination
Measure: Safety indexes of adverse events Time: 0-28 days post-vaccinationDescription: Occurrence of serious adverse events post-vaccination
Measure: Safety indexes of SAE Time: 0-28 days, within 6 mouths post-vaccinationDescription: Occurrence of abnormal changes of laboratory safety examinations
Measure: Safety indexes of lab measures Time: pre-vaccination, day 7 post-vaccinationDescription: Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of GMT(ELISA) Time: day14,28，month 3,6 post-vaccinationDescription: Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of GMT(pseudoviral neutralization test method) Time: day14,28，month 6 post-vaccinationDescription: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of seropositivity rates(ELISA) Time: day14,28，month 3,6 post-vaccinationDescription: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) Time: day14,28，month 6 post-vaccinationDescription: Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Measure: Immunogencity indexes of GMI(ELISA) Time: day14,28，month 3,6 post-vaccinationDescription: Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Measure: Immunogencity indexes of GMI(pseudoviral neutralization test method) Time: day14,28，month 6 post-vaccinationDescription: Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Measure: Immunogencity indexes of GMC(Ad5 vector) Time: day、14,28，month3,6 post-vaccinationDescription: Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Measure: Immunogencity indexes of GMI(Ad5 vector) Time: day、14,28，month3,6 post-vaccinationDescription: specific cellular immune responses
Measure: Immunogencity indexes of cellular immune Time: day 14, 28,month 6 post-vaccinationDescription: Consistency analysis of S-specific antibodies against 2019 novel coronavirus tested by ELISA against those tested by pseudoviral neutralization test method
Measure: Consistency analysis(ELISA and pseudoviral neutralization test method) Time: day,14,28, month 6 post-vaccinationDescription: Relationship between Geometric mean titer (GMT) of S protein-specific antibodies against 2019 novel coronavirus and vaccine dose among study groups
Measure: Dose-response relationship（Humoral immunity） Time: day14,28，month 3,6 post-vaccinationDescription: Persistence analysis of anti-S protein antibodies among study groups
Measure: Persistence analysis of anti-S protein antibodies Time: day14,28，month 3,6 post-vaccinationDescription: Relationship between the appearance time of S-specific antibodies against 2019 novel coronavirus and the vaccination dose.
Measure: Time-dose-response relationship（Humoral immunity） Time: day14,28，month 3,6 post-vaccinationDescription: Relationship between cellular immune levels against 2019 novel coronavirus and vaccine dose among study groups
Measure: Dose-response relationship（ cellular immunity） Time: day 14, 28,month 6 post-vaccinationDescription: Persistence analysis of specific cellular immune response
Measure: Persistence analysis of cellular immuse Time: day 14, 28,month 6 post-vaccinationDescription: Relationship between the appearance time of cellular immunity against 2019 novel coronavirus and the vaccination dose.
Measure: Time-dose-response relationship（cellular immunity） Time: day 14, 28,month 6 post-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 doseThis is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.
Description: Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination by severity score, duration, and peak intensity.
Measure: Frequency of solicited local and systemic reactogenicity adverse events (AEs) Time: until follow up day 7Description: Safety laboratory values (Serum Chemistry) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
Measure: Safety Laboratory Values (Serum Chemistry) Time: until follow up day 7Description: Safety laboratory values (Hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
Measure: Safety Laboratory Values (Hematology) Time: until follow up day 7Description: Percentage of participants with serious undesirable effect associated with the use of a medical product in a patient, which consist of death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), dan other serious important medical events
Measure: Frequency of any serious adverse events (SAEs) Time: until follow up day 365Description: NOCMCs will be documented from the time of study vaccination through approximately 1 year after study vaccination
Measure: Frequency of any new-onset chronic medical conditions (NOCMCs) Time: until follow up day 365Description: Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 365 by MedDRA classification, severity score, and relatedness.
Measure: Frequency of medically attended adverse events (MAAEs) Time: until follow up day 365Description: Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all MAAEs) or AESIs (potential immune-mediated medical conditions or AEs relevant to COVID-19) through the first 90 days by MedDRA classification, severity score, and relatedness.
Measure: Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs) Time: until follow up day 90Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 28.
Measure: Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs) Time: until follow up day 28Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs through Day 28.
Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs) Time: until follow up day 28Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs through Day 28. SCR is the proportion of participants with ≥4-fold rises in ELISA units.
Measure: Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs) Time: until follow up day 28Description: Neutralizing antibody activity as detected by microneutralization assay (MN) expressed as GMTs at multiple time points through Day 28.
Measure: Neutralizing Antibody Activity Expressed as GMTs Time: until follow up day 28Description: Neutralizing antibody activity as detected by MN expressed as GMFRs at multiple time points through Day 28.
Measure: Neutralizing Antibody Activity Expressed as GMFRs Time: until follow up day 28Description: Neutralizing antibody activity as detected by MN expressed as SCRs at multiple time points through Day 28.
Measure: Neutralizing Antibody Activity Expressed as SCRs Time: until follow up day 28Description: Cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro peripheral blood mononuclear cell (PBMC) stimulation (eg, enzyme-linked immunospot [ELISpot], cytokine staining) with SARS-CoV-2 rS protein(s) through Day 28.
Measure: Assessment of Cell-Mediated (T helper 1 [Th1]/T helper 2 [Th2]) Pathways Time: until follow up day 28Description: Measurement of IgG in subject blood after one month
Measure: Optimal dose of SARS-CoV2 antigen and GM-CSF Time: until follow up month oneDescription: Measurement of IgG and neutralizing antibody in subject blood after 12 months
Measure: Duration of detection IgG and neutralizing antibody againts SARS-CoV-2in blood after vaccination Time: until follow up month 12This 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 groupThis 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 vaccinationThe 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 57This 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 current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have been or are being developed, these require testing in animal and human safety studies and they are unlikely to be available during the expected peak periods of the growing epidemic. Two groups at especially high risk of infection and disease are front line health care workers working directly with COVID-19 patients and elderly residents of group homes or facilities that provide skilled nursing care to this frail population. Interim measures to protect these groups while we await a high efficacy vaccine are desperately needed. Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in children and adults; (2) exert antiviral effects in experimental models; and (3) reduce viremia in an experimental human model of viral infection, we hypothesize that BCG vaccination may induce (partial) protection against susceptibility to and/or severity of SARS-CoV-2 infection. This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and mitigate COVID-19 disease severity in at risk health care providers. A phase III randomized controlled trial provides the highest validity to answer this research question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would allow other at-risk individuals, including the control population, to also benefit from the intervention if and as soon as it has demonstrated efficacy and safety.
Description: The primary outcome measure is the development of symptomatic COVID 19 infections. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of rt-PCR-confirmed symptomatic SARS-CoV-2 infection following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.
Measure: Incidence of symptomatic rt-PCR-confirmed SARS-CoV-2 infection Time: 6 monthsDescription: The secondary outcome measure is the development of Serology-confirmed infection with SARS-CoV-2. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of serology-confirmed SARS-CoV-2 following BCG vaccination compared to that following placebo, starting from 3 days post vaccination through 6 months.
Measure: incidence of Serology-confirmed infection with SARS-CoV-2 Time: 6 monthsDescription: In individuals who test positive for COVID-19, the proportion with severe disease following BCG vaccination compared to placebo, as defined by the following necessary care levels: non- hospital 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 severity indicators of severe pneumonia, respiratory failure, sepsis, septic shock will also be included.
Measure: severity of COVID-19 disease Time: 6 monthsDescription: Incidence of self-reported symptomatic respiratory infections following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.
Measure: symptomatic respiratory infection Time: 6 monthsDescription: rates of 1) all cause respiratory infection 2) symptomatic COVID- 19, 3) serology-confirmed SARS-CoV-2 infection in health care workers.
Measure: effect of prior adult immunization with other vaccines associated with trained immunity Time: 6 monthsThis 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, 9Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study
Description: CTCAE-scoring
Measure: Safety / Tolerability Time: 35 daysDescription: Antibody response COVID-19
Measure: Immunogenicity Time: 180 daysThis 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 9A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine.
Description: COVID-19 virologically confirmed symptomatic cases (PCR positive).
Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR Time: 12 months post final vaccinationDescription: Occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination (in a subset of 200 participants)
Measure: Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of signs and symptoms of local and systemic reactogenicity requested during 7 days after vaccination Time: 7 days post vaccinationDescription: Occurrence of serious adverse events
Measure: Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of serious adverse events Time: 12 months post final vaccinationDescription: Occurrence of episodes; intensified disease
Measure: Evaluate the safety, tolerability and reactogenicity profile of ChAdOx1 nCoV-19 candidate vaccine: occurrence of episodes; intensified disease Time: 12 months post final vaccinationDescription: Hospitalization for COVID-19 disease confirmed by PCR
Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: hospitalization for COVID-19 disease confirmed by PCR Time: 12 months post final vaccinationDescription: COVID-19 serious disease confirmed by PCR
Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: COVID-19 serious disease confirmed by PCR Time: 12 months post final vaccinationDescription: Death associated with COVID-19 disease
Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: death associated with COVID-19 disease Time: 6 monthsDescription: Antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates).
Measure: Evaluate the efficacy of ChAdOx1 nCoV-19 candidate vaccine against severe and non-severe COVID-19 disease: antibodies against SARS-CoV-2 non-Spike protein (serum efficacy rates) Time: 12 months post final vaccinationDescription: Antibodies against the SARS-CoV-2 spike protein (serum conversion rates)
Measure: Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: antibodies against the SARS-CoV-2 spike protein (serum conversion rates) Time: 12 months post final vaccinationDescription: Virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus
Measure: Evaluate the humoral immunogenicity of ChAdOx1 nCoV-19: virus neutralizing antibodies (NAb) against live and/or pseudotyped SARS-CoV-2 virus Time: 12 months post final vaccinationDescription: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Measure: Assess the cellular immunogenicity of ChAdOx1 nCoV-19 candidate vaccine Time: 12 months post final vaccinationA phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in healthy UK volunteers.
Description: Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19
Measure: Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older. Time: Study duration (12 months from last vaccination)Description: Occurrence of serious adverse events (SAEs) throughout the study duration.
Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults Time: Study duration (12 months from last vaccination)Description: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited local reactogenicity signs and symptoms for 7 days following Time: 7 days post vaccinationDescription: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following Time: 7 days post vaccinationDescription: Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19: occurrence of unsolicited adverse events (AEs) for 28 days following vaccination Time: 28 days post vaccinationDescription: Frequency of participants with clinically significant changes from baseline for safety laboratory measures (haematology and biochemistry blood results; except groups 4, 6, 9 & 10)
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 through standard blood tests (full blood count, liver and kidney function tests) Time: 6 monthsDescription: Occurrence of disease enhancement episodes
Measure: Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19 by measuring the number of disease enhancement episodes Time: Study duration (12 months from last vaccination)Description: Number of hospital admissions associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: hospital admissions Time: Study duration (12 months from last vaccination)Description: Number of intensive care unit (ICU) admissions associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 Time: 6 monthsDescription: Number of deaths associated with COVID-19
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19: number of deaths Time: 6 monthsDescription: Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates Time: 6 monthsDescription: Proportion of people diagnosed with severe Covid-19 disease (defined according to clinical severity scales)
Measure: Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring incidence of Covid-19 Time: Study duration (12 months from last vaccination)Description: Quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)
Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19: antibody quantification Time: 28 days post vaccinationDescription: Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 28 post-vaccination
Measure: Assess humoral immunogenicity of ChAdOx1 nCoV-19: seroconversion Time: 28 days post vaccinationDescription: Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein
Measure: Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays (groups 1, 2, 7 and 8 only) Time: 6 monthsDescription: Occurrence of solicited local reactogenicity signs and symptoms for 7 days following booster vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only): local reactogenicity Time: 7 days post vaccinationDescription: Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following booster vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only): systemic reactogenicity Time: 7 days post vaccinationDescription: Occurrence of unsolicited adverse events (AEs) for 28 days following booster vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) Time: 28 days post vaccinationDescription: Frequency of participants with clinically significant changes from baseline from pre-booster for safety laboratory measures (haematology and biochemistry blood results)
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) through standard blood tests (full blood count, liver and kidney function tests) Time: 6 monthsDescription: Antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination (seroconversion rates)
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) via seroconversion Time: 56 days post vaccinationDescription: Proportion of seroconversion to antibodies against SARS-CoV-2 spike protein at Day 56 post-vaccination
Measure: Assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1 and 2 only) Time: 56 days post vaccinationDescription: Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus
Measure: Exploratory Immunology by virus neutralising antibody assays Time: 6 monthsDescription: Cell analysis by flow cytometry assays
Measure: Exploratory Immunology by flow cytometry Time: 6 monthsDescription: Functional antibody assays
Measure: Exploratory Immunology by functional antibody assays Time: 6 monthsDescription: Anti-vector immunity induced by 1 or 2 doses of ChAdOx1 nCoV-19
Measure: Exploratory Immunology: anti-vector immunity Time: 6 monthsDescription: Reported by weekly survey to collect information about cases amongst household contacts and friends, contact with the general public, infection control procedures
Measure: Measure exposure to COVID-19 Time: 6 monthsDescription: Number of PCR or NAAT positive cases of COVID-19 infection
Measure: Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection by PCR or NAAT Time: 6 monthsDescription: Measure of differences in viral loads between those with severe, mild, and asymptomatic PCR+ SARS-CoV-2 infections
Measure: Exploratory efficacy against infection: assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection Time: 6 monthsDescription: Differences in safety, reactogenicity and immunogenicity profiles between Group 1 in COV001 and Group 5 in COV002 (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).
Measure: Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002 Time: 6 monthsDescription: Differences in safety, reactogenicity and immunogenicity profiles between Groups 1, 2, and 5A compared with Groups, 7, 8, and 5B, C and D respectively (proportion of Grade 3 solicited AEs, occurrence of fevers, seroconversion rates at D28, neutralising antibody titres and differences in T-cell responses at D14).
Measure: Compare safety, reactogenicity and immunogenicity between different methods for measuring doses Time: 6 monthsDescription: Nasal mucosa IgA levels at D0 and D28 in a subset of individuals
Measure: Assess vaccine induced mucosal immunity: Nasal mucosa IgA levels at D0 and D28 in a subset of individuals Time: 6 monthsDescription: Differences in viral shedding on stool at 7 days and beyond post SARS-CoV-2 PCR or NAAT positivity
Measure: Compare viral shedding on stool samples of SARS-CoV-2 PCR or NAAT positive individuals Time: 6 monthsDescription: Differences in antibody titres (ELISA and Neutralising antibodies) in participants who received 1 or 2 doses of ChAdOx1 nCoV-19 (groups 1, 2, 7 and 8)
Measure: Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: differences in antibody titres Time: 6 monthsDescription: Longevity of immune responses in participants who received 1 or 2 doses of ChAdOx1 nCoV-19
Measure: Compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses in groups 1, 2, 7 and 8: longevity of immune responses Time: 6 monthsDescription: Differences reactogenicity profile, antibody titres and T-cell responses between groups 5d and 11 and their relationship with anti-vector neutralising antibody titres.
Measure: Describe the impact of previous vaccination with other ChAdOx1 vectored vaccines on safety and immune responses to ChAdOx1 nCoV-19 Time: 6 monthsDescription: Cell-mediated and humoral responses against SARS-Cov-2 These will be measured by the following: Proportion of seroconversion to antibodies (Ab) against SARS-CoV-2 spike protein measured by ELISA. Interferon-gamma enzyme linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein Intracellular Cytokine analyses of CD4 and CD8-specific SARS-CoV-2 spike protein responses Further exploratory immunology
Measure: Assess the cell-mediated and humoral immunogenicity profile of ChAdOx1 nCoV-19 vaccine in HIV infected adults Time: 6 monthsDescription: Relationship between nadir CD4 count vs vaccine immune responses
Measure: Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults: CD4 count-vaccine immune responses Time: 6 monthsDescription: Relationship between age at enrolment and vaccine immune response
Measure: Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults: age vs vaccine immune responses Time: 6 monthsDescription: Immune responses to ChAdOx1 nCoV-19 (assessed as described above)
Measure: Assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults Time: 6 monthsDescription: Measured by the following: Occurrence of serious adverse events (SAEs) throughout the study duration Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination Occurrence of solicited systemic signs and symptoms for 7 days following each vaccination Occurrence of unsolicited AEs for 28 days following each vaccination
Measure: Assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in HIV infected adults Time: Study duration (12 months from last vaccination)Description: Change in Total HIV DNA copies per million CD4 T cells
Measure: To assess Impact of vaccination on HIV reservoirs Time: Study duration (12 months from last vaccination)This protocol tests the safety and efficacy of a novel universal vaccine concept called "allo-priming" which is designed to protect elderly adults from progression of any type of viral infection, including possible protection against progression of the current outbreak of COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2 virus as well as protection from any future currently unknown newly emergent novel viruses.
Description: vaccine events such as fever, rash, abnormal vital signs
Measure: frequency of vaccine events Time: day 0 to day 28Description: measurement of Th1/Th2 balance, allo-specific Th1/CTL response
Measure: Proportion of subjects with positive T-cell response Time: day 0 to 1 yearDescription: ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B
Measure: Proportion of subjects able to suppress viral propagation Time: day 0 to 1 yearAlphabetical 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