Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2660 participants
OBSERVATIONAL
2024-10-19
2026-05-31
Brief Summary
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Detailed Description
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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%.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary Cohort
Cohort Provides blood draws during on-study visits
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Years
ALL
Yes
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Responsible Party
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Locations
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Walgreens - 3298 S John Young Pkwy
Kissimmee, Florida, United States
Walgreens - 1554 E 55th St
Chicago, Illinois, United States
Walgreens - 4385 S Archer Ave
Chicago, Illinois, United States
Walgreens - 811 Madison St
Oak Park, Illinois, United States
Walgreens - 7251 Lake St
River Forest, Illinois, United States
Walgreens - 15100 W 87th Street Pkwy
Lenexa, Kansas, United States
Walgreens - 7500 Metcalf Ave
Overland Park, Kansas, United States
Walgreens - 215 Beach St
Malden, Massachusetts, United States
Walgreens - 17811 E US Highway 24
Independence, Missouri, United States
Walgreens - 3845 Broadway Blvd
Kansas City, Missouri, United States
Walgreens - 2630 NE Vivion
Kansas City, Missouri, United States
Walgreens - 6401 W Charleston Blvd
Las Vegas, Nevada, United States
Walgreens - 1445 W Craig Rd
North Las Vegas, Nevada, United States
Walgreens - 3218 Atlantic Ave
Atlantic City, New Jersey, United States
Walgreens - 520 Convery Blvd
Perth Amboy, New Jersey, United States
Walgreens - 420 N Frazier St
Conroe, Texas, United States
Walgreens - 1919 W Gray St
Houston, Texas, United States
Walgreens - 7440 FM 1960 Rd E
Humble, Texas, United States
Walgreens - 8430 Broadway St
Pearland, Texas, United States
Walgreens - 3316 Avenue H
Rosenberg, Texas, United States
Countries
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Other Identifiers
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RRPV-24-02-Retail-009
Identifier Type: -
Identifier Source: org_study_id
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