The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19. This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. All participants in this study will receive 1 shot to their arm of a BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg RNA-based vaccine which targets a circulating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6 months for each participant. Participants will either be enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participants enrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2 will have at least 3 visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
774
BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain)
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
GW Vaccine Research Unit
Washington D.C., District of Columbia, United States
The GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, United States
...and 9 more locations
Percentage of participants reporting local reactions
Time frame: For up to 7 days after vaccination
Percentage of participants reporting systemic events
Time frame: For up to 7 days after vaccination
Percentage of participants reporting adverse events
Time frame: Through 1 month after vaccination
Percentage of participants reporting serious adverse events
Time frame: Through 6 months after vaccination
Cohort 1: Geometric Mean Titers (GMTs)
Time frame: At 2 weeks after vaccination
Cohort 1: Geometric Mean Fold Rises (GMFRs)
Time frame: From before vaccination to 2 weeks after vaccination
Cohort 1: Percentages of participants with seroresponse
Time frame: 2 weeks after vaccination
Cohort 2: Geometric Mean Fold Rises (GMFRs)
Time frame: From before vaccination to 1 month after vaccination
Cohort 1: Geometric Mean Titers (GMTs)
Time frame: At 1 month after vaccination
Cohort 1: Geometric Mean Fold Rises (GMFRs)
Time frame: From before vaccination to 1 month after vaccination
Cohort 1: Percentages of participants with seroresponse
Time frame: 1 month after vaccination
Cohort 2: Geometric Mean Titers (GMTs)
Time frame: From before vaccination to 1 month after vaccination
Cohort 2: Percentages of participants with seroresponse
Time frame: 1 month after vaccination
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