A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age

NCT07730450 · tracked via the Priya Life Science USA tracker

Sponsor

BioNTech SE

Phase

Phase 4

Started

2026-07-23

Last updated

2026-08-07

Condition(s) studied

COVID-19 Vaccines

Investigational drug(s) / intervention(s)

BNT162b2 VaccineTdap Vaccine

BNT162b2 Vaccine: Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1.

Tdap Vaccine: Participants will receive a single injection containing Tdap on Day 1.

Study summary

The purpose of this study is to learn about the safety and effects of an updated COVID-19 vaccine (called BNT162b2) in adults 18 to 64 years of age.

This study is seeking participants who:

* are medically stable
* have not had a recent COVID-19 infection
* have not had a recent vaccination
* do not have medical conditions that increase their risk of complications from COVID-19

All participants in this study will randomly receive 1 injection into their arm of either:

* BNT162b2 vaccine which targets COVID-19 and is selected for the 2026-2027 COVID-19 season, or
* Tdap vaccine which targets tetanus, diphtheria, and pertussis (whooping cough).

The study team and participants will not know which injection they receive. We will evaluate safety and SARS-CoV-2 spike protein levels in people receiving each of these vaccines.

Participants will be in the study for about 12 months.

Eligibility

Sex

ALL

Min age

18 Years

Max age

64 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Percentage of participants reporting local reactions or systemic events — From Day 1 up to 7 days after Vaccination
Percentage of participants reporting adverse events — From Day 1 through 1 month after vaccination
Percentage of participants reporting serious adverse events — From Day 1 through 12 months after vaccination
Spike protein levels — Up to 12 months after vaccination

Trial sites (5)

Facility	City	Region	Status
Diablo Clinical Research, LLC dba Flourish Research	Walnut Creek	California	Recruiting
Palm Springs Community Health Center	Miami Lakes	Florida	Recruiting
East-West Medical Research Institute	Honolulu	Hawaii	Recruiting
Duke Vaccine and Trials Unit	Durham	North Carolina	Recruiting
J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07730450 on ClinicalTrials.gov ↗ ← All trials in the USA