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

Not Applicable

Recruiting

• Conditions: COVID-19; SARS-COV-2 Infection
• Interventions: Biological: BNT162b2 (Omi LP.8.1)

• Registration Number: NCT07069309
• Lead Sponsor: BioNTech SE

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Study Start: 2025-07-08
• Study First Posted: 2025-07-16
• Last Update Submitted: 2025-07-30
• Last Update Posted: 2025-08-03
• Primary Completion: 2026-01-06
• Study Completion: 2026-01-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: 18 through 64 years of age (higher-risk individuals)	BNT162b2 (Omi LP.8.1)	Participants will receive BNT162b2 (Omi LP.8.1) 30 µg at Visit 1
Group 2: 65 years of age and older	BNT162b2 (Omi LP.8.1)	Participants will receive BNT162b2 (Omi LP.8.1) 30 µg at Visit 1

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting local reactions	For up to 7 days after vaccination
Percentage of participants reporting systemic events	For up to 7 days after vaccination
Percentage of participants reporting adverse events	Through 1 month after vaccination
Percentage of participants reporting serious adverse events	Through 6 months after vaccination
Geometric Mean Titers (GMTs)	At 2 weeks after vaccination
Geometric Mean Fold Rises (GMFRs)	From before vaccination to 2 weeks after vaccination
Percentages of participants with seroresponse	2 weeks after vaccination

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs)	At 1 month after vaccination
Geometric Mean Fold Rises (GMFRs)	From before vaccination to 1 month after vaccination
Percentages of participants with seroresponse	1 month after vaccination

Trial Locations

Locations (6)

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Indago Research & Health Center, Inc; 🇺🇸 Hialeah, Florida, 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

Accellacare - Wilmington; 🇺🇸 Wilmington, North Carolina, United States

J. Lewis Research, Inc. / Foothill Family Clinic; 🇺🇸 Salt Lake City, Utah, United States