An observational study in COVID - 19, sponsored by Biomedical Advanced Research and Development Authority. Completed at 20 sites in United States. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Biomedical Advanced Research and Development Authority · Observational
Despite the availability of vaccines, there remains a need to identify specific immune responses that correlate with protection against SARS-CoV-2 infection. Additionally, the operational capability of retail pharmacy infrastructure to collect longitudinal data and biological samples needs to be assessed. This study aims to fill these gaps by determining correlates of protection (CoP), assessing the infrastructure's capability, and examining demographic and geographic differences in participation.
This multi-center study will utilize a prospective, longitudinal observational design to assess CoR and CoP for COVID-19 vaccinations. Prior to enrollment in this study, participants will receive a federally licensed and authorized vaccine, manufactured by Pfizer-BioNTech or Moderna, for the prevention of COVID-19. Each participant will complete a pre-screener questionnaire which will collect information to confirm the participant's eligibility. Upon passing the pre-screener, the participant will complete their electronic consent form and will be enrolled in the study within 72 hours of their vaccination with blood collected to establish baseline for humoral immune marker. A subset of total enrollment, a cohort of 80 participants, will also enroll in the PBMC cohort; participants in the PBMC cohort will enroll in the study within 24 hours of their vaccination with blood collected to establish baseline immune marker levels.
During this study, participants will complete five (5) visits on site (Day 01, Day 31, Day 91, Day 181, Day 366), which will involve data collection and a blood draw. Participants enrolled in the PBMC cohort will have an additional blood draw at Day 01, Day 31, Day 181, and Day 366.
All study participants will complete a weekly electronic patient reported outcome (ePRO) to report symptoms of COVID-19, and to report if they have been exposed to anyone who has tested positive for COVID-19.
Participants will be asked to report to the clinic for a nasal swab test (via molecular assay) when: participant has at least one symptom with or without a fever, and/or if the participant has recent exposure or close contact to another person with COVID-19.
This study aims to enroll at least 90 COVID-19 endpoint cases, based on an annual incidence rate of 2.5%.
Prior to enrollment in this study, participants will receive a federally licensed and authorized vaccine, manufactured by Pfizer-BioNTech or Moderna, for the prevention of COVID-19. Each participant will complete a pre-screener questionnaire which will collect information to confirm the participant's eligibility. Upon passing the pre-screener, the participant will complete their electronic consent form and will be enrolled in the study within 72 hours of their vaccination with blood collected to establish baseline for humoral immune marker. A subset of total enrollment, a cohort of 80 participants, will also enroll in the PBMC cohort; participants in the PBMC cohort will enroll in the study within 24 hours of their vaccination with blood collected to establish baseline immune marker levels.
PBMC cohort only:
People ages ≥18 years at time of enrollment. Available for first blood sample collection within 1 day of vaccine.
Exclusion Criteria:
PBMC cohort only:
Confirmed positive urine pregnancy test at study visits per Schedule of Activities.
Cohort Provides blood draws during on-study visits
Biological: FDA approved mRNA vaccines
Up to 80 participants providing PBMCs
Biological: FDA approved mRNA vaccines
This study is non-interventional as participants will have received an FDA approved mRNA COVID-19 vaccine prior to entering the study. The study protocol does not determine or allocate receipt of vaccine
Serum S protein-specific binding antibody (bAb) concentrations (peak and exposure proximal assessments) Serum SARS-CoV-2 specific neutralizing antibody (nAb) titers (peak and exposure proximal assessments);
Correlates of Protective Immunity
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Valid Viable specimens for SARS-CoV-2 testing
Number of viable specimens collected at retail pharmacies or retail clinics over the Day 366 follow-up period that meet quality standards required for laboratory analysis.
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5).
Number of viable specimens for laboratory analysis
Viable specimens collected at retail pharmacies or retail clinics that meet quality standards required for laboratory analysis.
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Number of valid specimens for CoP testing
Valid specimens collected at retail pharmacies or retail clinics that meet quality standards required for CoP testing.
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Representativeness of number of self-collected nasal swabs and blood specimens
Number of self-collected nasal swabs and blood specimens received over the Day 366 follow-up period overall and stratified by participant demographic and social determinants of health.
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5). Various
Representativeness of Number of valid COVID-19 tests
COVID-19 resulting in a positive or negative result for SARS-CoV-2 infection overall and stratified by participant demographic and social determinants of health.
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Assessment of participant recruitment speed
Participant recruitment speed measured as time of vaccination to time of enrollment, overall and by site, as well as time to full enrollment overall and stratified by age.
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Assessment of participant retention
Participant retention over study period (from Day 1 through Day 366 follow-up) overall and stratified by age.
Time frame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Biomedical Advanced Research and Development Authority