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    Vaccine

    This report considers only clinical trials that are associated with COVID-19 vaccines.

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (54)


    Name (Synonyms) Correlation
    drug678 CVnCoV Vaccine Wiki 0.38
    drug2490 Placebo Wiki 0.35
    drug157 Ad26.COV2.S Wiki 0.31
    Name (Synonyms) Correlation
    drug384 BNT162b1 Wiki 0.31
    drug3578 Vaccinated with polio vaccine (IPV) Wiki 0.27
    drug674 CVnCoV Wiki 0.27
    drug840 Comparable Placebo of drug Wiki 0.27
    drug1437 Heparin Wiki 0.27
    drug385 BNT162b2 Wiki 0.27
    drug454 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group Wiki 0.27
    drug103 ARCT-021 single dose priming Wiki 0.27
    drug677 CVnCoV 6 μg Wiki 0.27
    drug739 ChAdOx1 nCoV-19 single dose + paracetamol Wiki 0.27
    drug1359 GM-CSF Wiki 0.27
    drug2108 NA-831 Wiki 0.27
    drug2504 Placebo (two doses), priming Wiki 0.27
    drug2002 MenACWY single dose + paracetamol Wiki 0.27
    drug386 BNT162b3 Wiki 0.27
    drug676 CVnCoV 12μg Wiki 0.27
    drug2593 Pneumococcal vaccine Wiki 0.27
    drug740 ChAdOx1 nCoV-19 two dose + paracetamol Wiki 0.27
    drug1443 Hepatitis A vaccine Wiki 0.27
    drug2312 One COVID-19 vaccine candidate (TMV-083) administration - High dose Wiki 0.27
    drug452 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki 0.27
    drug453 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki 0.27
    drug2503 Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) Wiki 0.27
    drug3494 Two COVID-19 vaccine candidate (TMV-083) administrations - High dose Wiki 0.27
    drug829 Combination of oral polio vaccine and NA-831 Wiki 0.27
    drug1583 IIBR-100, low dose (prime) Wiki 0.27
    drug458 Biological: oral polio vaccine Wiki 0.27
    drug3495 Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose Wiki 0.27
    drug1582 IIBR-100 medium dose (prime) Wiki 0.27
    drug1581 IIBR-100 low-dose (prime-boost) Wiki 0.27
    drug1869 Low Dose of KBP-COVID-19 Wiki 0.27
    drug2787 Randomized booster Wiki 0.27
    drug2001 MenACWY prime & saline placebo boost + paracetamol Wiki 0.27
    drug2806 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Wiki 0.27
    drug105 ARCT-021 two lower dose priming Wiki 0.27
    drug104 ARCT-021 two higher dose priming Wiki 0.27
    drug839 Comparable Placebo of Oral Polio Vaccine and Placebo of drug Wiki 0.27
    drug838 Comparable Placebo Wiki 0.27
    drug1447 High Dose of KBP-COVID-19 Wiki 0.27
    drug675 CVnCoV 12 μg Wiki 0.27
    drug623 COVID-19 convalescent plasma Wiki 0.27
    drug1580 IIBR-100 high-dose (prime) Wiki 0.27
    drug928 Covax-19™ Wiki 0.27
    drug1210 EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) Wiki 0.27
    drug2530 Placebo booster Wiki 0.27
    drug2988 Saline Placebo Wiki 0.19
    drug370 BCG-Denmark Wiki 0.15
    drug119 AV-COVID-19 Wiki 0.15
    drug366 BCG Vaccine Wiki 0.13
    drug2805 Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki 0.12
    drug2985 Saline Wiki 0.12

    Correlated MeSH Terms (6)


    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.39
    D045169 Severe Acute Respiratory Syndrome NIH 0.27
    D018450 Disease Progression NIH 0.19
    Name (Synonyms) Correlation
    D011014 Pneumonia NIH 0.19
    D007239 Infection NIH 0.13
    D003141 Communicable Diseases NIH 0.11

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0002090 Pneumonia HPO 0.19

    Clinical Trials

    Navigate: Correlations   HPO

    There are 14 clinical trials


    1 A Randomized, Double-blind, Placebo -Controlled Phase IIb Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV in Person 6 Years of Age and Older and Those Who Have Previously Been Vaccinated With Ad5-EBOV

    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 .

    NCT04566770
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    2. Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo

    Primary Outcomes

    Description: Occurrence of adverse reactions post vaccination

    Measure: Safety indexes of adverse reactions

    Time: within 14 days post each vaccination

    Description: Evaluate the Geometric mean titer (GMT) of IgG antibody

    Measure: Immunogencity indexes of GMT

    Time: Day 28 post the second vaccination

    Description: Evaluate the Geometric mean titer (GMT) of neutralizing antibody

    Measure: Immunogencity indexes of neutralizing antibody

    Time: Day 28 post the second vaccination

    Secondary Outcomes

    Description: Occurrence of adverse reactions post-vaccination

    Measure: Safety indexes of adverse events

    Time: Day 0-7,0-14,0-28 post each vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Description: Occurrence of serious adverse events post-vaccination

    Measure: Safety indexes of SAE

    Time: Within 6 months post the second vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination
    2 A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older

    This study aims to: - Demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants. - Demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episode of virologically-confirmed moderate to severe cases of COVID-19 in SARS-CoV-2 naïve participants.

    NCT04652102
    Conditions
    1. Covid19
    2. SARS-CoV-2
    Interventions
    1. Biological: CVnCoV
    2. Biological: Placebo

    Primary Outcomes

    Measure: Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity

    Time: Day 1 to Day 393

    Measure: Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of moderate to severe COVID-19

    Time: Day 1 to Day 393

    Measure: Number of participants who experience one or more medically-attended adverse events (AEs)

    Time: Day 29 to Day 211

    Measure: Intensity grading of medically-attended adverse events (AEs) per FDA toxicity grading scale

    Time: Day 29 to Day 211

    Measure: Number of participants who experience one or more treatment-related medically-attended adverse events (AEs)

    Time: Day 29 to Day 211

    Measure: Number of participants who experience one or more serious adverse events (SAEs)

    Time: Day 29 to Day 393

    Measure: Intensity grading of serious adverse events (SAEs) per FDA toxicity grading scale

    Time: Day 29 to Day 393

    Measure: Number of participants who experience one or more treatment-related serious adverse events (SAEs)

    Time: Day 29 to Day 393

    Measure: Number of participants who experience one or more adverse events of special interest (AESI)

    Time: Day 29 to Day 393

    Measure: Intensity grading of adverse events of special interest (AESI) per FDA toxicity grading scale

    Time: Day 29 to Day 393

    Measure: Number of participants who experience one or more treatment-related adverse events of special interest (AESI)

    Time: Day 29 to Day 393

    Measure: Number of participants who experience a fatal serious adverse event (SAE)

    Time: Day 29 to Day 393

    Secondary Outcomes

    Measure: Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} severe case of COVID-19

    Time: Day 1 to Day 393

    Description: Seroconversion is defined as detectable SARS-CoV-2 N protein antibodies in the serum of asymptomatic seronegative participants who tested seronegative on Day 1 and on Day 43.

    Measure: Number of participants with seroconversion to the nucleocapsid (N) protein of SARS-CoV-2 ≥ 15 days after the second study vaccination

    Time: Days 1, 43, 211 and 393

    Measure: Number of participants aged ≥ 61 who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity

    Time: Day 1 to Day 393

    Measure: Number of participants who experience a virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} SARS-CoV-2 infection, with or without symptoms

    Time: Day 1 to Day 393

    Measure: Burden of disease (BoD) based on first episodes of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} cases of COVID-19

    Time: Day 1 to Day 393

    Measure: Number of participants who experience a virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity with symptom onset at any time after the first study vaccination

    Time: Post vaccination on Day 1 up to Day 393

    Description: S protein will be measured by enzyme-linked immunosorbent assay (ELISA).

    Measure: Number of participants with serum antibodies to SARS-CoV-2 spike (S) protein

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Description: S protein will be measured by enzyme-linked immunosorbent assay (ELISA). Seroconversion is defined as detectable SARS-CoV-2 S protein antibodies in the serum of participants who tested seronegative on Day 1.

    Measure: Number of participants who experience seroconversion to SARS-CoV-2 spike (S) protein

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Description: Serum vital neutralizing antibodies to SARS-CoV-2 virus will be measured by a viral neutralizing antibody assay.

    Measure: Number of participants with serum vital neutralizing antibodies to SARS-CoV-2 virus

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Description: Seroconversion to SARS-CoV-2 virus will be measured by a viral neutralizing antibody assay. Seroconversion is defined as detectable SARS-CoV-2 viral neutralizing antibodies in the serum of participants who tested seronegative on Day 1.

    Measure: Number of participants who experience seroconversion to SARS-CoV-2 virus

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Measure: Phase 2b participants only: Number of participants who experience one or more solicited local adverse events (AEs)

    Time: 7 days after vaccination

    Measure: Phase 2b participants only: Intensity grading of solicited local adverse events (AEs) per FDA toxicity grading scale

    Time: 7 days after vaccination

    Measure: Phase 2b participants only: Duration of solicited local adverse events (AEs)

    Time: 7 days after vaccination

    Measure: Phase 2b participants only: Number of participants who experience one or more solicited systemic adverse events (AE)

    Time: 7 days after vaccination

    Measure: Phase 2b participants only: Intensity grading of solicited systemic adverse events (AEs)

    Time: 7 days after vaccination

    Measure: Phase 2b participants only: Duration of solicited systemic adverse events (AEs)

    Time: 7 days after vaccination

    Measure: Phase 2b participants only: Number of participants who experience one or more unsolicited adverse events (AEs)

    Time: 28 days after vaccination

    Measure: Phase 2b participants only: Intensity grading of unsolicited adverse events (AEs)

    Time: 28 days after vaccination

    Measure: Phase 2b participants only: Number of participants who experience one or more treatment-related unsolicited adverse events (AEs)

    Time: 28 days after vaccination

    Measure: Number of participants who experience one or more adverse events (AEs) leading to vaccine withdrawal or trial discontinuation

    Time: Day 29 to Day 393
    3 A Randomized, Placebo-controlled Trial, to Evaluate the Safety and Immunogenicity of the COVID-19 Vaccine, a Measles Vector-based Vaccine Candidate Against COVID-19 in Healthy Volunteers Consisting of an Unblinded Dose Escalation and a Blinded Treatment Phase

    This 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).

    NCT04497298
    Conditions
    1. COVID-19
    Interventions
    1. Biological: Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose
    2. Biological: Two COVID-19 vaccine candidate (TMV-083) administrations - High dose
    3. Biological: One COVID-19 vaccine candidate (TMV-083) administration - High dose
    4. Other: Placebo

    Primary Outcomes

    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 390

    Secondary Outcomes

    Description: 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 390

    Description: 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 390

    Description: 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 390

    Description: 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 42

    Other Outcomes

    Description: 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 28

    Description: 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 390

    Description: 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 390
    4 A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of a Prophylactic SARS-CoV-2 RNA Vaccine (BNT162b3) Against COVID-19 Using Different Dosing Regimens in Healthy Adults

    This 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.

    NCT04537949
    Conditions
    1. Covid-19
    2. Protection Against COVID-19
    Interventions
    1. Biological: BNT162b3

    Primary Outcomes

    Measure: Solicited local reactions at the injection site (pain/tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Measure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE) occurring up to 21±2 days after the prime immunization.

    Time: 21 days following dose administration

    Measure: The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the boost immunization.

    Time: 28 days following dose administration

    Secondary Outcomes

    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 administration

    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: Fold increase in functional antibody titers.

    Time: up to 365 days following dose administration

    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: 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 administration
    5 A First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of KBP-COVID-19 SARS-CoV-2 Vaccine With Adjuvant in Healthy Seronegative Adults Aged 18-49 and 50-70

    This is an First In Human (FIH), observer-blinded, randomized, placebo-controlled, parallel group study to evaluate the safety and immunogenicity of KBP-COVID-19 vaccine in healthy CoV-2seronegative adult subjects in 2 age groups, Part A (18-49 years) and Part B (50-70 years).

    NCT04473690
    Conditions
    1. Covid19
    Interventions
    1. Biological: Low Dose of KBP-COVID-19
    2. Biological: High Dose of KBP-COVID-19
    3. Biological: Placebo

    Primary Outcomes

    Description: Occurrence of Adverse Events

    Measure: Solicited Administration site reactions

    Time: 7 days after vaccination

    Description: Occurrence of Adverse Events

    Measure: Solicited systemic events

    Time: 7 days after vaccination

    Secondary Outcomes

    Description: Safety Endpoints

    Measure: Unsolicited Adverse Events and medically attended adverse events

    Time: 43 days after vaccination

    Description: Safety Endpoints

    Measure: Serious Adverse Events, Medically Attended Adverse Events and New Onset Chronic Diseae

    Time: 365 days after vaccination

    Description: Immunogenicity

    Measure: Vaccine ELISA and neutralizing antibody titers for each treatment group

    Time: Baseline, Day 8, 15, 22, 29, 43, 90, 181, 273, 365

    Description: Immunogenicity

    Measure: Seroconversion rates

    Time: Days 8, 15, 22, 29, 43, 90, 181, 273, 365
    6 A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

    This 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.

    NCT04368728
    Conditions
    1. SARS-CoV-2 Infection
    2. COVID-19
    Interventions
    1. Biological: BNT162b1
    2. Biological: BNT162b2
    3. Other: Placebo

    Primary Outcomes

    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 2

    Description: 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 2

    Description: 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 dose

    Description: 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 dose

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 1 day after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 7 days after dose 1

    Description: As measured at the central laboratory

    Measure: Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values

    Time: 7 days after dose 2

    Description: 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 1

    Description: 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 1

    Description: 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 2

    Description: 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 2

    Description: 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 2

    Description: 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 dose

    Description: 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 dose

    Description: 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 2

    Description: 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 2

    Description: 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 dose

    Description: 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 dose

    Description: 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 years

    Description: 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 years

    Description: 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 dose

    Description: 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 dose

    Description: 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 2

    Description: 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 2

    Secondary Outcomes

    Description: 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 dose

    Description: 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 dose

    Description: 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 dose

    Description: 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 dose

    Description: 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 dose

    Description: 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 dose

    Description: 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 dose

    Description: 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 years

    Description: 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 years

    Description: 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 years

    Description: 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 years

    Description: 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 years

    Description: 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 years

    Description: 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 years

    Description: 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 years

    Description: 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 years

    Description: 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 years

    Description: 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 dose
    7 COVID-19: A Phase 1, Partially Blind, Placebo-controlled, Dose Escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults

    This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.

    NCT04449276
    Conditions
    1. Severe Acute Respiratory Syndrome
    2. Coronavirus
    3. SARS-CoV-2
    4. COVID-19
    Interventions
    1. Biological: CVnCoV Vaccine
    2. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: This data will be collected for decisions on subsequent vaccination of an additional open-label sentinel group with the same dose level.

    Measure: Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination

    Time: Up to 24 hours after vaccination on Day 1

    Description: This data will be collected for decisions on dose escalation as well as continuation of enrollment at the same dose level in the observer-blind placebo-controlled part of the trial.

    Measure: Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination

    Time: Up to 60 hours after vaccination on Day 1

    Measure: Number of Participants with Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine

    Time: 7 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events

    Time: 28 days after vaccination

    Measure: Intensity of Unsolicited Adverse Events Assessed by the Investigator

    Time: 28 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

    Time: 28 days after vaccination

    Measure: Number of Participants with One or More Serious Adverse events (SAEs)

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Serious Adverse events (SAEs) Considered Related to Trial Vaccine

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

    Time: Baseline to Day 393

    Secondary Outcomes

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

    Time: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

    Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

    Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

    Description: Measured using an activity assay.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

    Time: Baseline and on Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

    Description: Measured using an activity assay.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393

    Description: Measured using an activity assay.

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

    Time: On Day 8, Day 15, Day 29, Day 36, Day 43, Day 57, Day 120, Day 211 and Day 393
    8 A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Clinical Study Evaluating the Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany)

    This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (S) protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years of age or older included in a subset of participants.

    NCT04674189
    Conditions
    1. Coronavirus
    2. Covid19
    3. SARS-CoV-2
    4. Severe Acute Respiratory Syndrome
    Interventions
    1. Biological: CVnCoV Vaccine
    2. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Number of Participants with Medically-attended Adverse Events

    Time: Day 29 to Day 211

    Measure: Intensity of Medically-attended Adverse Events per Investigator's Assessment

    Time: Day 29 to Day 211

    Measure: Number of Participants with Medically-attended Adverse Events Considered Related to Trial Vaccine

    Time: Day 29 to Day 211

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs)

    Time: Day 29 to Day 393

    Measure: Intensity of Serious Adverse Events (SAEs) per Investigator's Assessment

    Time: Day 29 to Day 393

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine

    Time: Day 29 to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

    Time: Day 29 to Day 393

    Measure: Intensity of Adverse Events of Special Interest (AESIs) per Investigator's Assessment

    Time: Day 29 to Day 393

    Measure: Number of Participants with One or More Serious Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

    Time: Day 29 to Day 393

    Measure: Number of Participants with Death due to a Serious Adverse Event (SAE)

    Time: Day 29 to Day 393

    Measure: Number of Participants with Adverse Events (AEs) Leading to Vaccine Withdrawal or Study Disctontinuation

    Time: Day 29 to Day 393

    Measure: Number of Participants with Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events

    Time: 28 days after vaccination

    Measure: Intensity of Unsolicited Adverse Events per the Investigator's Assessment

    Time: 28 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

    Time: 28 days after vaccination

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike (S) Protein-Specific Antibody Levels in Serum

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA). Seroconversion is defined as detectable SARS-CoV-2 RBD of S protein antibodies in the serum of participants who tested seronegative on prior to vaccination on Day 1.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike (S) Protein Antibodies

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Secondary Outcomes

    Measure: Number of Participants that Contract COVID-19 of Any Severity

    Time: Day 1 to Day 393

    Measure: Number of Participants that Contract Mild, Moderate, Severe and Moderate to Severe COVID-19

    Time: Day 1 to Day 393

    Description: Seroconversion is defined as detectable SARS-CoV-2 N protein antibodies in the serum of subjects on Day 211 and/or Day 393 of the trial, who tested seronegative at prior to vaccination on Day 1 and Day 43.

    Measure: Number of Participants Seroconverting to the Nucleocapsid (N) Protein of SARS-SoV-2

    Time: Day 1, 43, 211 and 393

    Measure: Burden of Disease (BoD) Score Based on First Episodes of Virologically-confirmed Cases of COVID-19

    Time: Day 1 to Day 393

    Description: Measured by a virus neutralizing assay in a subset of participants.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Description: Measured by a virus neutralizing assay in a subset of participants.

    Measure: Number of Participants Seroconverting to SARS-CoV-2

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Description: Measured by a virus neutralizing assay in a subset of participants.

    Measure: Individual Serum Antibodies to Spike (S) Protein of SARS-CoV-2

    Time: Days 43, 57, 120, 211 and 393
    9 A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

    The study will enroll up to 60,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.

    NCT04505722
    Conditions
    1. Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol
    Interventions
    1. Biological: Ad26.COV2.S
    2. Other: Placebo
    MeSH:Disease Progression

    Primary Outcomes

    Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.

    Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status

    Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)

    Secondary Outcomes

    Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.

    Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus

    Time: 1 Day post-vaccination (Day 2) to end of study (2.1 Years)

    Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.

    Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease COVID-19 Regardless of Their Serostatus

    Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)

    Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.

    Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19)

    Time: 1 Day post-vaccination (Day 2) to end of study (2.1 Years)

    Description: Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination will be reported.

    Measure: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention

    Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)

    Description: The viral load of SARS-CoV-2 will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.

    Measure: SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19

    Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)

    Description: Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.

    Measure: Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19

    Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)

    Description: Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.

    Measure: Number of Participants with First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized case Definition

    Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)

    Description: BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.

    Measure: Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19

    Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)

    Description: Serologic conversion between baseline and (Day 1; pre-vaccination), Day 71, 6 Months, 1 year post-vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.

    Measure: Serologic Conversion Between Baseline and (Day 1; Pre-vaccination), Day 71, 6 Months and 1- Year Post-vaccination using an Enzyme-linked Immunosorbent Assay (ELISA)

    Time: Between baseline (Day 1; pre-vaccination) and Day 71, 6 Months, 1-Year post-vaccination (up to 52 Weeks)

    Description: Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after vaccination (Day 15) to end of Study (2.1 Years) will be reported.

    Measure: Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed)

    Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)

    Description: SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

    Measure: Number of Participants with Serious Adverse Events (SAEs)

    Time: Up to 104 Weeks

    Description: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.

    Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs)

    Time: Up to 6 Months

    Description: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.

    Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Leading to Study Discontinuation

    Time: Up to 104 Weeks

    Description: Participants will be asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

    Measure: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination

    Time: Up to Day 8 (7 Days after first vaccination on Day 1)

    Description: Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.

    Measure: Number of Participants with Solicited Systemic AEs During 7 Days Following Vaccination

    Time: Up to Day 8 (7 Days after first vaccination on Day 1)

    Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

    Measure: Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination

    Time: Up to Day 29 (28 Days after first vaccination on Day 1)

    Description: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported

    Measure: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA)

    Time: Up to 104 Weeks

    Description: SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.

    Measure: SARS-CoV-2 Binding Antibodies Assessed by ELISA

    Time: Up to 104 Weeks
    10 COVID-19: A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age

    This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.

    NCT04515147
    Conditions
    1. Coronavirus
    2. Covid19
    3. SARS-CoV-2
    4. Severe Acute Respiratory Syndrome
    Interventions
    1. Biological: CVnCoV 6 μg
    2. Biological: CVnCoV 12 μg
    3. Biological: Hepatitis A vaccine
    4. Biological: Pneumococcal vaccine
    5. Biological: CVnCoV 12μg
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Number of Participants with Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine

    Time: 7 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events

    Time: 28 days after vaccination

    Measure: Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale

    Time: 28 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

    Time: 28 days after vaccination

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs)

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

    Time: Baseline to Day 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

    Time: Day 29

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

    Time: Day 43

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

    Time: Day 29

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

    Time: Day 43

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

    Time: Day 29

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

    Time: Day 43

    Description: Measured using an activity assay.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

    Time: Day 29

    Description: Measured using an activity assay.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

    Time: Day 43

    Description: Measured using an activity assay.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: Day 29

    Description: Measured using an activity assay.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: Day 43

    Description: Measured using an activity assay.

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

    Time: Day 29

    Description: Measured using an activity assay.

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

    Time: Day 43

    Secondary Outcomes

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Number of Participants with Solicited Local Adverse Events Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Duration of Solicited Local Adverse Events Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Number of Participants with Solicited Systemic Adverse Events Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Duration of Solicited Systemic Adverse Events Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Number of Participants with Unsolicited Adverse Events Following the Booster Vaccine

    Time: 28 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine

    Time: 28 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine

    Time: 28 days after booster vaccination

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393

    Description: Measured using an activity assay.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393

    Description: Measured using an activity assay.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393

    Description: Measured using an activity assay.

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393
    11 Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind Study

    This is a phase I, randomized, placebo-controlled, observer-blind study, for evaluation of safety and immunogenicity of SARS-CoV-2 mRNA vaccine (BNT162b1) in Chinese healthy population. After randomization, the trial for each subject will last for approximately 12 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and each dose of either SARS-CoV-2 vaccine (BNT162b1) or placebo will be given intramuscularly (IM).

    NCT04523571
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: BNT162b1
    2. Other: Placebo

    Primary Outcomes

    Measure: Occurrence of solicited local reactions in the subjects (e.g., vaccination sites: pain/tenderness, erythema/redness, induration/swelling) during the 14-days after each dose of BNT162b1 or placebo.

    Time: 14 days following each dose administration

    Measure: Occurrence of solicited systematic reactions (e.g., nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) during 14-day after each dose of BNT162b1 or placebo.

    Time: 14 days following each dose administration

    Measure: Occurrence of adverse event (AE) associated with vaccination in subjects during the 21-day period after prime vaccination of BNT162b1 or placebo.

    Time: 21-day period after prime vaccination

    Measure: Occurrence of AE associated with vaccination in subjects during the 28-day period after boost dose of BNT162b1 or placebo.

    Time: 28-day period after boost dose

    Secondary Outcomes

    Measure: The proportion of subjects experiencing serious adverse events (SAEs), occurring up to Day 21 after prime vaccination and Day 28 after boost vaccination, up to Month 3, 6 and 12.

    Time: Day 21 after prime vaccination, Day 28 after boost vaccination, and Month 3, 6 and 12

    Measure: The proportion of subjects experiencing AE associated with BNT162b1, occurring up to Month 3, 6 and 12.

    Time: up to Month 3, 6 and 12

    Measure: The proportion of subjects experiencing abnormal markers of hematology, blood chemistry and urine analysis, occurring at Hour 24 and Day 7 after prime vaccination and Day 7 period after boost dose of BNT162b1 or placebo.

    Time: Hour 24 and Day 7 after prime vaccination and Day 7 after boost dose

    Measure: Geometric mean titer (GMT) of anti-S1 IgG antibody at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: GMT of anti-receptor binding domain (RBD) immunoglobulin G (IgG) antibody at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: GMT of SARS-CoV-2 neutralizing antibody (including true virus-based SARS-CoV-2 neutralizing test) at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: Fold increase in antibody anti-S1 IgG antibody titers, as compared to baseline, at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: Fold increase in antibody anti-RBD IgG antibody titers, as compared to baseline, at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: Fold increase in SARS-CoV-2 neutralizing antibody titers (virus neutralizing test), as compared to baseline, at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: Seroconversion rates (SCR) defined as a minimum of 4-fold increase of antibody titers, as compared to baseline, at Day 7, Day 21 after prime vaccination, and at Day 7, Day 21 after boost vaccination.

    Time: Day 7, Day 21 after prime vaccination, and Day 7, Day 21 after boost vaccination
    12 Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blinded Study

    This is a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population. After randomization, the trial for each participant will last for approximately 13 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo will be given intramuscularly (IM) separated by 21 days.

    NCT04649021
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: BNT162b2
    2. Other: Placebo

    Primary Outcomes

    Description: SCR of SARS-CoV-2 serum neutralizing titers at 1-month after dose 2. Seroconversion is defined as ≥4-fold rise from before vaccination to 1-month post dose 2.

    Measure: SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR)

    Time: 1 Month after Dose 2

    Measure: The geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers at 1 month after dose 2

    Time: 1 Month after Dose 2

    Secondary Outcomes

    Description: Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 serum neutralizing titers - SCR

    Time: 1 Week, 6 and 12 Months after Dose 2

    Description: GMT of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 serum neutralizing titers - GMT

    Time: 1 Week, 6 and 12 Months after Dose 2

    Description: Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 anti-S1 immunoglobulin G (IgG) antibody level - SCR

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: GMT of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 anti-S1 IgG antibody level - GMT

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: Compared with baseline before Vaccination 1, the GMFR of SARS-CoV-2 serum neutralizing antibody titers at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 serum neutralizing antibody level - Geometric mean fold rise (GMFR)

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: Compared with baseline before Vaccination 1, GMFR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 anti-S1 IgG antibody level - GMFR

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: Pain at the injection site, redness, and swelling as self-reported on diary cards.

    Measure: Percentage of participants reporting local reactions

    Time: Within 7 Days and 14 Days after each vaccination

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on diary cards.

    Measure: Percentage of participants reporting systemic events

    Time: Within 7 Days and 14 Days after each vaccination

    Description: Percentage of participants with abnormal hematology laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.

    Measure: Hematology laboratory assessments

    Time: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2

    Description: Percentage of participants with abnormal chemistry laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.

    Measure: Chemistry laboratory assessments

    Time: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2

    Description: Percentage of participants with grading shifts in hematology laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.

    Measure: Hematology laboratory assessments

    Time: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2

    Description: Percentage of participants with grading shifts in chemistry laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.

    Measure: Chemistry laboratory assessments

    Time: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2

    Description: AEs from dose 1 to 1 month after the last dose.

    Measure: Adverse events (AEs)

    Time: From Dose 1 through 1 Month after the last Dose

    Description: SAEs from dose 1 to 6 months after the last dose.

    Measure: Serious AEs (SAEs)

    Time: From Dose 1 through 6 Months after the last Dose
    13 A Phase I/II Randomized, Multi-Center, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults

    The 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.

    NCT04608305
    Conditions
    1. Covid19
    Interventions
    1. Biological: IIBR-100, low dose (prime)
    2. Biological: IIBR-100 medium dose (prime)
    3. Biological: IIBR-100 high-dose (prime)
    4. Biological: IIBR-100 low-dose (prime-boost)
    5. Other: Saline Placebo
    6. Other: Saline Placebo

    Primary Outcomes

    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 vaccination

    Measure: Phase II - IIBR-100 Immunogenicity as determined by GMT, GMFR, Seroconversion rates of the neutralizing antibody titers to SARS-CoV-2 per group at 28 days following last vaccination (in relation to Day 0-baseline).

    Time: 28 days post last vaccination

    Secondary Outcomes

    Description: 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 vaccination

    Description: 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 vaccination

    Description: 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 vaccination

    Other Outcomes

    Measure: phase I and II - Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19, 14 days after having received on or two active vaccine injections

    Time: 14 days post last vaccination

    Measure: phase I and II - Number of virologically confirmed (PCR positive) severe cases of COVID-19, 14 days after having received on or two active vaccine injections

    Time: 14 days post last vaccination

    Measure: phase I and II - Number of serology confirmed symptomatic cases of COVID-19, 14 days after having received on or two active vaccine injections

    Time: 14 days post last vaccination

    Description: 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 days
    14 A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older

    The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort, in healthy adults aged greater than or equal to 18 to less than or equal to 55 years and in adults aged greater than or equal to 65 years in good health with or without stable underlying conditions.

    NCT04436276
    Conditions
    1. Healthy
    Interventions
    1. Biological: Ad26.COV2.S
    2. Biological: Placebo

    Primary Outcomes

    Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination

    Time: Day 8 (7 Days after first vaccination on Day 1)

    Description: Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after second vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination

    Time: Day 64 (7 Days after second vaccination on Day 57)

    Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after first vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination

    Time: Day 8 (7 Days after first vaccination on Day 1)

    Description: Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after second vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination

    Time: Day 64 (7 Days after second vaccination on Day 57)

    Description: Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination

    Time: Day 29 (28 Days after first vaccination on Day1)

    Description: Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned.

    Measure: Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination

    Time: Day 85 (28 Days after second vaccination)

    Description: SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

    Measure: Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the Second Vaccination

    Time: From Day 57 (vaccination 2) up to 1 year

    Description: SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

    Measure: Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination

    Time: Day 1 (vaccination 1) up to 6 Months

    Secondary Outcomes

    Description: Number of participants with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported.

    Measure: Cohorts 1, 2, and 3: Number of Participants With SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA)

    Time: Up to 38 Months

    Description: Number of participants with SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.

    Measure: Cohorts 1, 2, and 3: Number of Participants with SARS-CoV-2 Binding Antibodies Assessed by ELISA

    Time: Up to 38 Months

    Description: Number of participants with Th-1 and Th-2 immune responses will be reported. Th1 and Th2 immune responses will be assessed by flow cytometry after SARS-CoV-2 S protein peptide stimulation of peripheral blood mononuclear cells (PBMCs) and intracellular staining [ICS] including cluster of differentiation (CD)-4+/CD-8+, Interferons (INF)-gamma, interleukin [IL] 2, Tumor Necrosis Factor (TNF)-alpha, IL-4, IL-5, IL-13, and/or other Th-1/Th-2 markers.

    Measure: Cohorts 1, 2, and 3: Number of Participants with T-helper (Th)-1 and Th-2 Immune Responses as Assessed by Flow Cytometry

    Time: Up to 38 Months

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    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.

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