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    2019-nCoV (mRNA-1273)

    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 (1)


    Name (Synonyms) Correlation
    drug3923 mRNA-1273 Wiki 0.58

    Correlated MeSH Terms (0)


    Name (Synonyms) Correlation

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

    This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. One hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.

    NCT04283461
    Conditions
    1. COVID-19
    2. COVID-19 Immunisation
    Interventions
    1. Biological: mRNA-1273

    Primary Outcomes

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

    Time: Through 7 days post-vaccination

    Measure: Frequency of any medically-attended adverse events (MAAEs)

    Time: Day 1 to Day 394

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

    Time: Day 1 to Day 394

    Measure: Frequency of any serious adverse events (SAEs)

    Time: Day 1 to Day 394

    Measure: Frequency of any unsolicited adverse events (AEs)

    Time: Through 28 days post-vaccination

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

    Time: Through 7 days post-vaccination

    Measure: Grade of any unsolicited adverse events (AEs)

    Time: Through 28 days post-vaccination

    Measure: Grade of solicited local reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Measure: Grade of solicited systemic reactogenicity adverse events (AEs)

    Time: Through 7 days post-vaccination

    Secondary Outcomes

    Measure: Geometric mean fold rise (GMFR) in IgG titer from baseline

    Time: Day 1 to Day 57

    Measure: Geometric mean titer (GMT) of antibody

    Time: Day 57

    Description: Seroconversion is defined as a 4-fold change in antibody titer from baseline

    Measure: Percentage of subjects who seroconverted

    Time: Day 1 to Day 57

    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