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    preemptive

    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 (3)


    Name (Synonyms) Correlation
    drug3947 multipeptide cocktail Wiki 1.00
    drug1366 Gam-COVID-Vac Wiki 0.38
    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 P-pVAC-SARS-CoV-2: Phase I Single-center Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults

    Part I: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). No more than one subject per day will be enrolled. 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the data safety monitoring board (DSMB) as well as an amendment to the regulatory authorities (Paul-Ehrlich Institute and Ethics Committee) before proceeding to Part II. Part II: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study investigational medicinal product (IMP) (CoVac-1). 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the DSMB whether to proceed to next Part III. Part III: 12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). The aim of the clinical is to evaluate the safety and immunogenicity of a single use of a SARS-CoV-2-derived multi-peptide vaccine in combination with the toll like receptor (TLR)1/2 ligand XS15 in adults

    NCT04546841
    Conditions
    1. COVID-19 Vaccine
    Interventions
    1. Biological: multipeptide cocktail
    MeSH:Infection

    Primary Outcomes

    Description: ECOG (Scale 0-5)

    Measure: Safety- Eastern Cooperative Oncology Group (ECOG) Status

    Time: Day 28

    Description: temperature (in grade centigrade)

    Measure: Safety -Vital Signs 2

    Time: Day 28

    Description: blood pressure/pulse mmHg and bpm Follow-Up Days:Signs/symptoms, as assessed on volunteer's diary and visit

    Measure: Safety -Vital Signs 3

    Time: Day 28

    Description: Alkaline phosphatase (AP) Unit: U/l

    Measure: Safety-Blood Chemistry and Coagulation 1

    Time: Day 28

    Description: aspartate transaminase (AST/ SGOT) Unit: U/l

    Measure: Safety-Blood Chemistry and Coagulation 2

    Time: Day 28

    Description: hemoglobin (Hb) Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing Unit: g/dl

    Measure: Safety-Hematology 1

    Time: Day 28

    Description: red blood cells (RBC) Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing Unit: Mio/µl

    Measure: Safety-Hematology 2

    Time: Day 28

    Description: platelet count (PLT) Unit: 1000/µl Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing

    Measure: Safety-Hematology 3

    Time: Day 28

    Description: white blood cells (WBC) Unit: 1/µl Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing.

    Measure: Safety-Hematology 4

    Time: Day 28

    Secondary Outcomes

    Description: 60 ml of heparin blood for immunomonitoring and analysis of peptide specific T-cell response will be analyzed by the Walz lab, KKE Translational Immunologie at the Department of Immunology, Tuebingen (central laboratory). Blood will be taken before peptide vaccination on V1, and during vaccination phase and follow-up at each visit. Unit:Counts

    Measure: CoVac-1 specific T-cell response

    Time: Day 28

    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