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

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.

Study Overview

• Status: Completed
• Conditions: COVID - 19
• Intervention / Treatment: Biological: FDA approved mRNA vaccines

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%.

• Study Type: Observational
• Enrollment (Actual): 2519

Contacts and Locations

Study Locations

• United States
  • Florida
    • Kissimmee, Florida, United States, 34746
      • Walgreens - 3298 S John Young Pkwy
  • Illinois
    • Chicago, Illinois, United States, 60615
      • Walgreens - 1554 E 55th St
    • Chicago, Illinois, United States, 60632
      • Walgreens - 4385 S Archer Ave
    • Oak Park, Illinois, United States, 60302
      • Walgreens - 811 Madison St
    • River Forest, Illinois, United States, 60305
      • Walgreens - 7251 Lake St
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Walgreens - 15100 W 87th Street Pkwy
    • Overland Park, Kansas, United States, 66204
      • Walgreens - 7500 Metcalf Ave
  • Massachusetts
    • Malden, Massachusetts, United States, 02148
      • Walgreens - 215 Beach St
  • Missouri
    • Independence, Missouri, United States, 64056
      • Walgreens - 17811 E US Highway 24
    • Kansas City, Missouri, United States, 64111
      • Walgreens - 3845 Broadway Blvd
    • Kansas City, Missouri, United States, 64119
      • Walgreens - 2630 NE Vivion
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Walgreens - 6401 W Charleston Blvd
    • North Las Vegas, Nevada, United States, 89032
      • Walgreens - 1445 W Craig Rd
  • New Jersey
    • Atlantic City, New Jersey, United States, 08401
      • Walgreens - 3218 Atlantic Ave
    • Perth Amboy, New Jersey, United States, 08861
      • Walgreens - 520 Convery Blvd
  • Texas
    • Conroe, Texas, United States, 77301
      • Walgreens - 420 N Frazier St
    • Houston, Texas, United States, 77019
      • Walgreens - 1919 W Gray St
    • Humble, Texas, United States, 77346
      • Walgreens - 7440 FM 1960 Rd E
    • Pearland, Texas, United States, 77584
      • Walgreens - 8430 Broadway St
    • Rosenberg, Texas, United States, 77471
      • Walgreens - 3316 Avenue H

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary Cohort; Cohort Provides blood draws during on-study visits	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
PBMC Cohort; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)

Collaborators and Investigators

• Sponsor: Biomedical Advanced Research and Development Authority

Publications and helpful links

Helpful Links

• Retail COVID-19 Study Website

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2024
• Primary Completion (Actual): May 14, 2026
• Study Completion (Actual): May 14, 2026

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): January 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Covid-19; Vaccines; Observational; Walgreens; Correlates of Protective Immunity; Retail Pharmacy
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: RRPV-24-02-Retail-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes