A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Adults, Including Those at Higher Risk of Severe COVID-19
Purpose
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 18 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 (Omi LP.8.1) 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, and participants will need to visit the clinical study site at least 4 times.
Conditions
- COVID-19
- SARS-COV-2 Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Participants 18 years of age or older. - Participants who have received a COVID-19 vaccine containing Omicron KP.2 >6 months (>175 days) prior to enrollment in the study and have not received any other COVID-19 vaccine or had physician-confirmed COVID-19 disease since this vaccination through to enrollment in the study. - Participants 18 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19. The following list of conditions have been developed utilizing conditions listed by the CDC and are deemed to increase the risk of developing severe COVID-19 disease in infected participants: - Asthma - Diabetes mellitus type I - Diabetes mellitus type II - Heart conditions (eg. previous coronary artery disease or heart failure but excluding cardiomyopathy, myocarditis and pericarditis) - HIV - Mental health conditions limited to mood disorders, including depression. - Parkinson disease - Obesity (BMI ≥30) - Smoking, current or former The medical conditions mentioned above must have remained stable for at least 6 weeks prior to enrollment.
Exclusion Criteria
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). - History of myocarditis or pericarditis. Refer to the study contact for further eligibility details.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1: 18 through 64 years of age (higher-risk individuals) |
Participants will receive BNT162b2 (Omi LP.8.1) 30 µg at Visit 1 |
|
|
Experimental Group 2: 65 years of age and older |
Participants will receive BNT162b2 (Omi LP.8.1) 30 µg at Visit 1 |
|
Recruiting Locations
Diablo Clinical Research, Inc.
Walnut Creek 5406990, California 5332921 94598
Walnut Creek 5406990, California 5332921 94598
Indago Research & Health Center, Inc
Hialeah 4158476, Florida 4155751 33012
Hialeah 4158476, Florida 4155751 33012
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield 4409896, Missouri 4398678 65802
Springfield 4409896, Missouri 4398678 65802
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield 4409896, Missouri 4398678 65807
Springfield 4409896, Missouri 4398678 65807
Accellacare - Wilmington
Wilmington 4499379, North Carolina 4482348 28401
Wilmington 4499379, North Carolina 4482348 28401
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City 5780993, Utah 5549030 84109
Salt Lake City 5780993, Utah 5549030 84109
More Details
- NCT ID
- NCT07069309
- Status
- Recruiting
- Sponsor
- BioNTech SE