Retail COVID-19 Study

NCT06761612 | Completed FDA Drug

• 1 other identifier: RRPV-24-02-Retail-009
• Study Type: observational
• Target: 2,519
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

COVID - 19

Keywords

Covid-19; Vaccines; Correlates of Protective Immunity; Retail Pharmacy; Walgreens; Observational

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)

Secondary Outcomes (4)

• Representativeness of number of self-collected nasal swabs and blood specimens

  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

  Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)

• Assessment of participant recruitment speed

  Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)

• Assessment of participant retention

  Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)

Study Arms (2)

Primary Cohort

Cohort Provides blood draws during on-study visits

Biological: FDA approved mRNA vaccines

PBMC Cohort

Up to 80 participants providing PBMCs

Biological: FDA approved mRNA vaccines

Interventions

FDA approved mRNA vaccines BIOLOGICAL

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

PBMC Cohort; Primary Cohort

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Biomedical Advanced Research and Development Authority: lead

Study Sites (20)

Walgreens - 3298 S John Young Pkwy

Kissimmee, Florida, 34746, United States

Location

Walgreens - 1554 E 55th St

Chicago, Illinois, 60615, United States

Location

Walgreens - 4385 S Archer Ave

Chicago, Illinois, 60632, United States

Location

Walgreens - 811 Madison St

Oak Park, Illinois, 60302, United States

Location

Walgreens - 7251 Lake St

River Forest, Illinois, 60305, United States

Location

Walgreens - 15100 W 87th Street Pkwy

Lenexa, Kansas, 66219, United States

Location

Walgreens - 7500 Metcalf Ave

Overland Park, Kansas, 66204, United States

Location

Walgreens - 215 Beach St

Malden, Massachusetts, 02148, United States

Location

Walgreens - 17811 E US Highway 24

Independence, Missouri, 64056, United States

Location

Walgreens - 3845 Broadway Blvd

Kansas City, Missouri, 64111, United States

Location

Walgreens - 2630 NE Vivion

Kansas City, Missouri, 64119, United States

Location

Walgreens - 6401 W Charleston Blvd

Las Vegas, Nevada, 89146, United States

Location

Walgreens - 1445 W Craig Rd

North Las Vegas, Nevada, 89032, United States

Location

Walgreens - 3218 Atlantic Ave

Atlantic City, New Jersey, 08401, United States

Location

Walgreens - 520 Convery Blvd

Perth Amboy, New Jersey, 08861, United States

Location

Walgreens - 420 N Frazier St

Conroe, Texas, 77301, United States

Location

Walgreens - 1919 W Gray St

Houston, Texas, 77019, United States

Location

Walgreens - 7440 FM 1960 Rd E

Humble, Texas, 77346, United States

Location

Walgreens - 8430 Broadway St

Pearland, Texas, 77584, United States

Location

Walgreens - 3316 Avenue H

Rosenberg, Texas, 77471, United States

Location

Related Links

• Retail COVID-19 Study Website

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 7, 2025
• Study Start: October 19, 2024
• Primary Completion: May 14, 2026
• Study Completion: May 14, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (20)