Clinical trial NCT06761612: Retail COVID-19 Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID - 19
Keywords: Covid-19
Vaccines
Correlates of Protective Immunity
Retail Pharmacy
Walgreens
Observational
Lead sponsor: Biomedical Advanced Research and Development Authority
Sponsor class: FED
First posted: 2025-01-07
Enrollment: 2660
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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%.

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.

Primary outcomes:
measure: 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)
measure: 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).
measure: Number of viable specimens for laboratory analysis
timeFrame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
measure: Number of valid specimens for CoP testing
timeFrame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Secondary outcomes:
measure: Representativeness of number of self-collected nasal swabs and blood specimens
timeFrame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5). Various
measure: Representativeness of Number of valid COVID-19 tests
timeFrame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
measure: Assessment of participant recruitment speed
timeFrame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
measure: Assessment of participant retention
timeFrame: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Other outcomes:
Locations:
city: Kissimmee
country: United States
facility: Walgreens - 3298 S John Young Pkwy
state: Florida
city: Chicago
country: United States
facility: Walgreens - 1554 E 55th St
state: Illinois
city: Chicago
country: United States
facility: Walgreens - 4385 S Archer Ave
state: Illinois
city: Oak Park
country: United States
facility: Walgreens - 811 Madison St
state: Illinois
city: River Forest
country: United States
facility: Walgreens - 7251 Lake St
state: Illinois
city: Lenexa
country: United States
facility: Walgreens - 15100 W 87th Street Pkwy
state: Kansas
city: Overland Park
country: United States
facility: Walgreens - 7500 Metcalf Ave
state: Kansas
city: Malden
country: United States
facility: Walgreens - 215 Beach St
state: Massachusetts
city: Independence
country: United States
facility: Walgreens - 17811 E US Highway 24
state: Missouri
city: Kansas City
country: United States
facility: Walgreens - 3845 Broadway Blvd
state: Missouri
city: Kansas City
country: United States
facility: Walgreens - 2630 NE Vivion
state: Missouri
city: Las Vegas
country: United States
facility: Walgreens - 6401 W Charleston Blvd
state: Nevada
city: North Las Vegas
country: United States
facility: Walgreens - 1445 W Craig Rd
state: Nevada
city: Atlantic City
country: United States
facility: Walgreens - 3218 Atlantic Ave
state: New Jersey
city: Perth Amboy
country: United States
facility: Walgreens - 520 Convery Blvd
state: New Jersey
city: Conroe
country: United States
facility: Walgreens - 420 N Frazier St
state: Texas
city: Houston
country: United States
facility: Walgreens - 1919 W Gray St
state: Texas
city: Humble
country: United States
facility: Walgreens - 7440 FM 1960 Rd E
state: Texas
city: Pearland
country: United States
facility: Walgreens - 8430 Broadway St
state: Texas
city: Rosenberg
country: United States
facility: Walgreens - 3316 Avenue H
state: Texas
Study officials:
References: