SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine
Condition: Covid19; SARS-CoV2 Infection
MeSH terms: COVID-19
Intervention: Study-provided Moderna mRNA-1273 COVID-19 vaccine; Community-provided Moderna mRNA-1273 COVID-19 Vaccine; Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine
Intervention description: Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).; Participants received a two-dose series.; Participants received a two-dose series.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and efficacy of mRNA COVID-19 vaccines
      in:

      • People with prior COVID-19 (SARS-CoV-2 infection) who were in the ACTIV-2/A5401 study.

      And

      • People who have never had COVID-19 (SARS-CoV-2 infection).
    

Eligibility criteria:

        Inclusion Criteria:

          -  For all participants: Ability and willingness of participant (or legally authorized
             representative) to provide informed consent prior to initiation of any study
             procedures.

          -  For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Receipt
             of all selected investigational therapy or active comparator/placebo for that therapy
             at selected sites.

          -  For participants who are in, or who have completed, the ACTIV-2/A5401 trial and
             receive study-provided Moderna mRNA-1273 COVID-19 vaccine: Receipt of the last dose of
             investigational therapy or active comparator/placebo for that therapy ≥30 days and
             ≤240 days prior to study entry.

          -  For participants who are in, or who have completed, the ACTIV-2/A5401 trial and have
             received or will be receiving community-provided mRNA-based COVID-19 vaccine: Receipt
             of the last dose of investigational therapy or active comparator/placebo for that
             therapy ≥30 and ≤240 days prior to receipt or planned receipt of the first dose of
             community-provided vaccine.

        Exclusion Criteria:

          -  For participants who are in, or who have completed, the ACTIV-2/A5401 trial:
             Self-report of prior receipt of a non-mRNA-based COVID-19 vaccine.

          -  For participants who are in, or who have completed, the ACTIV-2/A5401 trial:
             Self-report of receipt of the first dose of an mRNA-based COVID-19 vaccine 140 days or
             more before A5404 enrollment.

          -  For participants who are in, or who have completed, the ACTIV-2/A5401 trial:
             Self-report of a second SARS-CoV-2 infection after the infection that qualified the
             participant for ACTIV-2/A5401.

          -  For non-A5401/ACTIV-2 participants: Self-report of receipt of any prior COVID-19
             vaccine.

          -  For non-A5401/ACTIV-2 participants: Known prior history of any SARS-CoV-2-positive
             test (e.g., PCR test, Nucleic Acid Amplification Test (NAAT), antigen test, serology
             test).

          -  For participants who receive study-provided Moderna mRNA-1273 COVID-19 vaccine: Known
             allergy to any component of the Moderna COVID-19 vaccine.