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Retail COVID-19 Study

CompletedN/A

Sponsor: Biomedical Advanced Research and Development Authority

Conditions: COVID - 19

Interventions: FDA approved mRNA vaccines

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 3 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. People ≥3 years of age at time of enrollment.
2. Willing and able to provide informed consent, or assent in pediatric population, if appropriate, prior to initiation of study procedures.
3. Able to understand and comply with planned study procedures.
4. Available for all study data collection points.
5. 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.

PBMC cohort only:

People ages ≥18 years at time of enrollment. Available for first blood sample collection within 1 day of vaccine.

Exclusion Criteria:

1. Currently participating or plans to participate in another clinical trial involving an investigational product before completing this study.
2. Planned to receive another COVID-19 vaccine within 180 days.
3. Receipt of COVID-19 vaccination within 180 days prior to current vaccination.
4. 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.
5. Self-report of recently confirmed COVID-19 infection within 30 days.
6. Any disease or medical condition that, in the opinion of the principal investigator or sub-investigator, is a contraindication to study participation.

PBMC cohort only:

Confirmed positive urine pregnancy test at study visits per Schedule of Activities.

Locations (20)

Kissimmee, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Oak Park, Illinois, United States
River Forest, Illinois, United States
Lenexa, Kansas, United States
Overland Park, Kansas, United States
Malden, Massachusetts, United States
Independence, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
North Las Vegas, Nevada, United States
Atlantic City, New Jersey, United States
Perth Amboy, New Jersey, United States
Conroe, Texas, United States
Houston, Texas, United States
Humble, Texas, United States
Pearland, Texas, United States
Rosenberg, Texas, United States