Updated COVID-19 vaccine safety in healthy adults 18–64
Official title: A PHASE 4, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF A BNT162B2 RNA-BASED, VARIANT-ADAPTED VACCINE CANDIDATE AGAINST SARS-COV-2 AND EVALUATE THE CIRCULATING SARS-COV-2 SPIKE PROTEIN LEVEL IN HEALTHY PARTICIPANTS 18 THROUGH 64 YEARS OF AGE
Run by BioNTech SE · NCT07730450 · Data updated 2026-11-12
This study tests an updated COVID-19 vaccine and a booster vaccine in healthy adults to see how safe they are and how the body responds.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | BioNTech SE Industry-sponsored |
| Locations | 5 sites (Walnut Creek, California and 4 other locations) |
| Status | Recruiting |
| Started | July 23, 2026 |
| Main results expected | August 20, 2027 |
| Study ends | August 20, 2027 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT07730450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–64 without medical conditions that raise severe COVID-19 risk, who have not had a recent COVID-19 infection or recent vaccination.
✕Probably not a fit
Participants with recent COVID-19 infection, recent vaccination, or conditions increasing risk for complications from COVID-19 may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional, Phase 4 study enrolls adults aged 18–64 who are medically stable and have not recently had COVID-19 or any nonstudy vaccines. Participants are randomized to receive either the updated BNT162b2 vaccine or a Tdap booster, with neither participants nor study staff knowing which vaccine is given. The trial focuses on safety and measurements of SARS-CoV-2 spike protein levels over about 12 months. Sites include clinics in California, Florida, and Hawaii, led by BioNTech with Pfizer collaboration.
Why it matters
Potential benefit: If successful, the study could improve understanding of the safety and immune response of the updated COVID-19 vaccine for the 2026–2027 season.
How similar studies have gone: Previous studies of updated COVID-19 vaccines have shown acceptable safety and immune responses in adults, though this specific 2026–2027 formulation is being studied for confirmatory data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria \- Healthy participants 18 through 64 years of age who do not have medical conditions that put them at a higher risk for severe COVID-19. Key Exclusion Criteria * Participants who tested positive for COVID-19 within 6 months (180 days) prior to Visit 1 * Participants who have recently received a vaccine, or plan to receive a nonstudy COVID-19 or comparator vaccine during participation. The complete list of inclusion and exclusion criteria are listed in the protocol.
Where it's running
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Diablo Clinical Research, LLC dba Flourish Research
Walnut Creek, California, United States Recruiting -
Palm Springs Community Health Center
Miami Lakes, Florida, United States Recruiting -
East-West Medical Research Institute
Honolulu, Hawaii, United States Recruiting -
Duke Vaccine and Trials Unit
Durham, North Carolina, United States Recruiting -
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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COVID-19 vaccine for children and adults at risk of severe disease
This study tests an updated COVID-19 vaccine in people aged 5 to 64 with risk factors and adults 65+, to see how safe it is and how it behaves after vaccination.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.