Retail COVID-19 Study (NCT06761612) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Retail COVID-19 Study
United States2,660 participantsStarted 2024-10-19
Plain-language 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.
Who can participate
Age range3 Years
SexALL
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Inclusion criteria
✓. People ≥3 years of age at time of enrollment.
✓. Willing and able to provide informed consent, or assent in pediatric population, if appropriate, prior to initiation of study procedures.
✓. Able to understand and comply with planned study procedures.
✓. Available for all study data collection points.
✓. Receipt of the most recent FDA-licensed and authorized COVID-19 vaccine (i.e., the 2024-2025 Moderna COVID-19 vaccine or the 2024-2025 Pfizer-BioNTech COVID-19 vaccine which includes the KP.2 strain of the JN.1-lineage vaccine), as recommended by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) and outlined in the FDA's updated guidance, administered within 3 days of enrollment.
Exclusion criteria
✕. Currently participating or plans to participate in another clinical trial involving an investigational product before completing this study.
✕. Planned to receive another COVID-19 vaccine within 180 days.
✕. Receipt of COVID-19 vaccination within 180 days prior to current vaccination.
✕. Receipt of Shingrix vaccine in the 28 days prior to the COVID-19 vaccination or planned receipt of Shingrix vaccine within 28 days after receipt of COVID-19 vaccination.
✕. Self-report of recently confirmed COVID-19 infection within 30 days.
✕
What they're measuring
1
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);
Timeframe: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
2
Valid Viable specimens for SARS-CoV-2 testing
Timeframe: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5).
3
Number of viable specimens for laboratory analysis
Timeframe: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
4
Number of valid specimens for CoP testing
Timeframe: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Trial details
NCT IDNCT06761612
SponsorBiomedical Advanced Research and Development Authority
. Any disease or medical condition that, in the opinion of the principal investigator or sub-investigator, is a contraindication to study participation.