NCT06761612

Retail COVID-19 Study

A Longitudinal Assessment of Serology and Effectiveness to Determine COVID-19 Vaccine Correlates of Risk (CoR) and Correlates of Protection (CoP) in a Heterogeneous US Population Through Use of Decentralized Sites and Approaches for Data/Specimen Collection

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,660 (estimated)
• Sponsor: Biomedical Advanced Research and Development Authority · Federal
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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%.

Conditions

• COVID - 19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-19
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2025-01-07
• Last updated: 2025-05-09

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study