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    Reactogenicity

    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 (10)


    Name (Synonyms) Correlation
    drug677 CVnCoV 6 μg Wiki 0.71
    drug676 CVnCoV 12μg Wiki 0.71
    drug2593 Pneumococcal vaccine Wiki 0.71
    Name (Synonyms) Correlation
    drug1443 Hepatitis A vaccine Wiki 0.71
    drug675 CVnCoV 12 μg Wiki 0.71
    drug678 CVnCoV Vaccine Wiki 0.50
    drug370 BCG-Denmark Wiki 0.41
    drug366 BCG Vaccine Wiki 0.35
    drug2985 Saline Wiki 0.32
    drug2490 Placebo Wiki 0.09

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D045169 Severe Acute Respiratory Syndrome NIH 0.29
    D018352 Coronavirus Infections NIH 0.23

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 2 clinical trials


    1 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
    2 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

    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

    Google Colab

    Python example via Google Colab Notebook