Phase 4
N=43
SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine
Covid19 · SARS-CoV2 Infection
Bottom Line
View on ClinicalTrials.gov: NCT04952402 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Neutralizing Antibody (NAb) Level — 2242.47; 2695.21; 2196.74; 888.80 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Study-provided Moderna mRNA-1273 COVID-19 vaccine (Biological); Community-provided Moderna mRNA-1273 COVID-19 Vaccine (Biological); Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neutralizing Antibody (NAb) Level |
2242.47; 2695.21; 2196.74; 888.80; 972.43; 794.90 | — |
| SECONDARY Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine |
6.85; 21.63; 50.80; 8.31; 40.86; 33.05 | — |
| SECONDARY Proportion of Participants With New Grade 3 or Higher AE, or SAE, or AE Leading to Change or Discontinuation in Vaccine Receipt |
0.13; 0.00; 0.00 | — |
| SECONDARY Number of Participants With Grade 1 or Higher Allergic Reaction |
0; 0; 0 | — |
| SECONDARY Proportion of Participants With Grade 2 or Higher Injection Site Reaction |
0.00; 0.10; 0.00 | — |
| SECONDARY Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine by Received Vaccine |
37.75; 28.65 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04952402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.