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

Trial status:Recruiting
Trial ID:
C4591076
NCT ID:
NCT07069309
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
Pfizer
Recruiting

Trial Details

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.

Medical Condition
  • COVID-19
    • Study Drug
  • BNT162b2 (Omi LP.8.1)
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    100
    Estimated Trial Date
    Jul 2025 - Jan 2026

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    Yes
    Inclusion and Exclusion Criteria
    Inclusion criteria

      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.

    Trial Locations

    Location
    Status
    Location
    Diablo Clinical Research, Inc.
    Walnut Creek, California, United States, 94598
    Status
    Recruiting
    Location
    Indago Research & Health Center, Inc
    Hialeah, Florida, United States, 33012
    Status
    Recruiting
    Location
    Bio-Kinetic Clinical Applications, LLC dba QPS-MO
    Springfield, Missouri, United States, 65802
    Status
    Recruiting
    Location
    Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
    Springfield, Missouri, United States, 65807
    Status
    Recruiting
    Location
    Accellacare - Wilmington
    Wilmington, North Carolina, United States, 28401
    Status
    Recruiting
    Location
    J. Lewis Research, Inc. / Foothill Family Clinic
    Salt Lake City, Utah, United States, 84109
    Status
    Recruiting