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    Inactivated 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 (6)


    Name (Synonyms) Correlation
    drug2919 SARS-CoV-2 inactivated vaccine Wiki 1.00
    drug1395 Group B (Placebo) Wiki 1.00
    drug1394 Group B (AG0302-COVID19) Wiki 1.00
    Name (Synonyms) Correlation
    drug1391 Group A (Placebo) Wiki 1.00
    drug1390 Group A (AG0302-COVID19) Wiki 1.00
    drug2490 Placebo Wiki 0.13

    Correlated MeSH Terms (1)


    Name (Synonyms) Correlation
    D007239 Infection NIH 0.24

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 Multi-center, Phase 3, Double-blind, Randomized, Placebo-controlled, Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of an Inactivated Vaccine Against the SARS-CoV-2 Infection in High Risk of Infection Adults

    The study will evaluate the efficacy, safety, and immunogenicity of an inactivated vaccine against the SARS-CoV-2 infection in high risk of infection adults. Two doses of the vaccine or placebo will be administered in an 0 and 14 days schedule. Follow-up of safety and efficacy will be implemented by 12 months after the first dose. Immunogenicity will be studied in a subgroup of participants.

    NCT04651790
    Conditions
    1. Covid19
    2. Vaccines
    Interventions
    1. Biological: SARS-CoV-2 inactivated vaccine
    2. Other: Placebo
    MeSH:Infection

    Primary Outcomes

    Description: Vaccine efficacy to prevent virologically confirmed COVID-19 two weeks after the second vaccination will be determined

    Measure: Incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second vaccination

    Time: Two weeks after second dose up to one year after first dose

    Description: The frequency of solicited and unsolicited local and systemic adverse reactions will be registered. This will be measured during the first 7 days after each vaccination. These adverse reactions will be registered according to the age group in adult (18-59 years old) and elder (60 years of age or older) subjects.

    Measure: Frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects.

    Time: During the first 7 days after each dose of vaccine/placebo

    Secondary Outcomes

    Description: The incidence of cases confirmed through PCR for COVID-19 after administration of at least one dose of vaccine/placebo will be determined.

    Measure: Incidence of cases of virologically confirmed COVID-19 after administration of at least one dose of vaccine/placebo

    Time: Since first dose and up to 12 months after

    Description: The incidence of severe cases of COVID-19, confirmed through PCR, two weeks after the second vaccination, will be determined.

    Measure: Incidence of severe cases of COVID-19 virologically confirmed two weeks after the second vaccination

    Time: Since two weeks after the second dose up 12 month after first dose

    Description: The incidence of hospitalized cases of COVID-19 two weeks after the second vaccination will be determined.

    Measure: Incidence of hospitalized cases of COVID-19 two weeks after the second vaccination

    Time: Since two weeks after the second dose and up 12 month after first dose

    Description: The incidence of deaths due to COVID-19 two weeks after the second vaccination will be determined.

    Measure: Incidence of deaths due to COVID-19 two weeks after the second vaccination

    Time: Since two weeks after the second dose up 12 month after first dose

    Description: The incidence of adverse reactions to the vaccine, both local and systemic, solicited and unsolicited will be determined. These adverse reactions will be measured within the period of four weeks after each dose of vaccination. These adverse reactions will be registered according to the age group in adult (18-59 years old) and elder (60 years of age or older) subjects.

    Measure: Incidence of adverse reactions to the vaccine, local and systemic, solicited and unsolicited, within the period of four weeks after each dose of vaccination, according to the age group, adults (18-59 years old) and elder (60 years or older) subjects.

    Time: Four weeks after each dose of vaccine/placebo

    Description: The frequency of severe COVID-19 cases in participants who received at least one dose of vaccine/placebo will be determined.

    Measure: Frequency of severe COVID-19 cases in participants who received at least one dose of vaccine/placebo

    Time: Since first dose up to 12 month after

    Description: The occurrence of serious adverse events (SAE) and adverse events of special interest in participants who have received at least one dose of the vaccine, will be determined.

    Measure: Incidence of serious adverse events (SAE) and adverse events in participants who have received at least one dose of the vaccine

    Time: Since first dose up to 12 month after

    Description: The cellular immune response in a subgroup of participants, before and two and four weeks after the administration of each dose of the vaccine, will be evaluated.

    Measure: Percentage of participants that show a significant increase in SARS-CoV-2 specific T cells after vaccination, determined by flow Cytometry and ELISPOT

    Time: Since first dose up to 4 weeks after second dose

    Description: The presence of anti-SARS-CoV-2 antibodies in a subgroup of participants, before and two weeks after the administration of each dose of the vaccine, will be evaluated.

    Measure: Percentage of participants with a significant increase of anti-SARS-CoV-2 antibodies, determined by ELISA

    Time: Since first dose up to 2 weeks after second dose

    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