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    EpiVacCorona

    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 (4)


    Name (Synonyms) Correlation
    drug2503 Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) Wiki 1.00
    drug1210 EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) Wiki 1.00
    drug157 Ad26.COV2.S Wiki 0.58
    Name (Synonyms) Correlation
    drug2490 Placebo Wiki 0.13

    Correlated MeSH Terms (1)


    Name (Synonyms) Correlation
    D018450 Disease Progression NIH 0.71

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 Simple, Blind, Placebo-controlled, Randomized Study of the Safety, Reactogenicity and Immunogenicity of Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), in Volunteers Aged 18-60 Years (I-II Phase)

    The aim of the clinical study is to determine the safety, reactogenicity and immunogenicity parameters of the EpiVacCorona vaccine in volunteers aged 18-60 years. The research tasks are to: - evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly; - evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly; - identify the development of adverse reactions to vaccine administration; - study the humoral and cellular immune responses following two doses of the EpiVacCorona vaccine.

    NCT04527575
    Conditions
    1. Covid19
    Interventions
    1. Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)
    2. Other: Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)

    Primary Outcomes

    Description: • The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 9 months post vaccination versus a placebo.

    Measure: The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination

    Time: throughout the study, an average of 270 days

    Secondary Outcomes

    Description: • The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA greater ≥ 4 times 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination compared with a placebo.

    Measure: The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA following the vaccination compared with a placebo.

    Time: at days 0, 1, 14, 20, 35, 42, 90, 180, 270

    Description: • The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA greater than ≥ 4 times 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination, compared with a placebo.

    Measure: The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo

    Time: at days 0, 1, 14, 20, 35, 42, 90, 180, 270

    Description: • The proportion of volunteers with an ex vivo cellular immune response 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination, compared with a placebo.

    Measure: The proportion of volunteers with an ex vivo cellular immune response following the vaccination, compared with a placebo

    Time: at days 0, 1, 14, 20, 35, 42, 90, 180, 270

    Description: • Immediate adverse events (allergic reactions) that occur within 2 hours after vaccination and that are identified both by the clinical investigator and based on information provided by the volunteer; adverse events (local and systemic reactions) that occur within 7 days after vaccination and that are identified both by the clinical investigator and based on information provided by the volunteer; other adverse events that occur 7 days after each vaccination (from 8 to 42 days after the first vaccination, excluding the allowable interval of visits) and noted by the volunteer in the Self-observation Diary.

    Measure: Incidence and type of adverse events during the study

    Time: throughout the study, an average of 270 days

    Description: • Incidence of serious adverse events during the study.

    Measure: Incidence of serious adverse events during the study

    Time: throughout the study, an average of 270 days

    Description: • Cases of early termination of participation of volunteers in the study due to the development of adverse events / sever adverse events associated with the use of products under study.

    Measure: Cases of early termination of the study due to the development of adverse events / sever adverse events

    Time: throughout the study, an average of 270 days

    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.

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    Interventions

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    MeSH

    706 reports on MeSH terms

    HPO

    306 reports on HPO terms

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    Alphabetical index of all Terms

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