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    dendritic cell

    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
    drug119 AV-COVID-19 Wiki 0.58
    drug3574 VPM1002 Wiki 0.58
    drug2490 Placebo Wiki 0.13

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D003141 Communicable Diseases NIH 0.41
    D007239 Infection NIH 0.24

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 Adaptive Phase I Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From SARS-CoV-2, in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies

    This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.

    NCT04685603
    Conditions
    1. COVID-19
    Interventions
    1. Biological: AV-COVID-19

    Primary Outcomes

    Description: Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination by severity score, duration, and peak intensity.

    Measure: Frequency of solicited local and systemic reactogenicity adverse events (AEs)

    Time: until follow up day 7

    Description: Safety laboratory values (Serum Chemistry) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.

    Measure: Safety Laboratory Values (Serum Chemistry)

    Time: until follow up day 7

    Description: Safety laboratory values (Hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.

    Measure: Safety Laboratory Values (Hematology)

    Time: until follow up day 7

    Description: Percentage of participants with serious undesirable effect associated with the use of a medical product in a patient, which consist of death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), dan other serious important medical events

    Measure: Frequency of any serious adverse events (SAEs)

    Time: until follow up day 365

    Description: NOCMCs will be documented from the time of study vaccination through approximately 1 year after study vaccination

    Measure: Frequency of any new-onset chronic medical conditions (NOCMCs)

    Time: until follow up day 365

    Description: Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 365 by MedDRA classification, severity score, and relatedness.

    Measure: Frequency of medically attended adverse events (MAAEs)

    Time: until follow up day 365

    Description: Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all MAAEs) or AESIs (potential immune-mediated medical conditions or AEs relevant to COVID-19) through the first 90 days by MedDRA classification, severity score, and relatedness.

    Measure: Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs)

    Time: until follow up day 90

    Secondary Outcomes

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 28.

    Measure: Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs)

    Time: until follow up day 28

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs through Day 28.

    Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs)

    Time: until follow up day 28

    Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs through Day 28. SCR is the proportion of participants with ≥4-fold rises in ELISA units.

    Measure: Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs)

    Time: until follow up day 28

    Description: Neutralizing antibody activity as detected by microneutralization assay (MN) expressed as GMTs at multiple time points through Day 28.

    Measure: Neutralizing Antibody Activity Expressed as GMTs

    Time: until follow up day 28

    Description: Neutralizing antibody activity as detected by MN expressed as GMFRs at multiple time points through Day 28.

    Measure: Neutralizing Antibody Activity Expressed as GMFRs

    Time: until follow up day 28

    Description: Neutralizing antibody activity as detected by MN expressed as SCRs at multiple time points through Day 28.

    Measure: Neutralizing Antibody Activity Expressed as SCRs

    Time: until follow up day 28

    Description: Cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro peripheral blood mononuclear cell (PBMC) stimulation (eg, enzyme-linked immunospot [ELISpot], cytokine staining) with SARS-CoV-2 rS protein(s) through Day 28.

    Measure: Assessment of Cell-Mediated (T helper 1 [Th1]/T helper 2 [Th2]) Pathways

    Time: until follow up day 28

    Description: Measurement of IgG in subject blood after one month

    Measure: Optimal dose of SARS-CoV2 antigen and GM-CSF

    Time: until follow up month one

    Description: Measurement of IgG and neutralizing antibody in subject blood after 12 months

    Measure: Duration of detection IgG and neutralizing antibody againts SARS-CoV-2in blood after vaccination

    Time: until follow up month 12

    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