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    RNA 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 (17)


    Name (Synonyms) Correlation
    drug384 BNT162b1 Wiki 0.67
    drug840 Comparable Placebo of drug Wiki 0.58
    drug454 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group Wiki 0.58
    Name (Synonyms) Correlation
    drug739 ChAdOx1 nCoV-19 single dose + paracetamol Wiki 0.58
    drug2108 NA-831 Wiki 0.58
    drug2002 MenACWY single dose + paracetamol Wiki 0.58
    drug386 BNT162b3 Wiki 0.58
    drug740 ChAdOx1 nCoV-19 two dose + paracetamol Wiki 0.58
    drug452 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki 0.58
    drug453 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki 0.58
    drug829 Combination of oral polio vaccine and NA-831 Wiki 0.58
    drug458 Biological: oral polio vaccine Wiki 0.58
    drug2001 MenACWY prime & saline placebo boost + paracetamol Wiki 0.58
    drug839 Comparable Placebo of Oral Polio Vaccine and Placebo of drug Wiki 0.58
    drug838 Comparable Placebo Wiki 0.58
    drug385 BNT162b2 Wiki 0.29
    drug2490 Placebo Wiki 0.15

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.28
    D045169 Severe Acute Respiratory Syndrome NIH 0.12

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 3 clinical trials


    1 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
    2 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
    3 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

    No related HPO nodes (Using clinical trials)


    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    No related HPO nodes (Using clinical trials)


    Reports

    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  

    Interventions

    4,818 reports on interventions/drugs

    MeSH

    706 reports on MeSH terms

    HPO

    306 reports on HPO terms

    All Terms

    Alphabetical index of all Terms

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    Python example via Google Colab Notebook