A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults

Trial status:Recruitment Complete
Trial ID:
C5031001
NCT ID:
NCT05703607
EudraCT ID:
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.
Pfizer
Recruitment Complete

Trial Details

The purpose of this clinical study is to learn about the safety, extent of the side effects (reaction to vaccine), and immune response (your immune system's reaction) of the study vaccine called Varicella Zoster Virus modRNA (VZV modRNA). We are seeking for healthy participants who are between 50 and 69 years of age. This study will be conducted in 2 substudies: Substudy A (Phase 1) and Substudy B (Phase 2). Substudy A: This substudy is the Phase 1 portion of the study. In this substudy, participants will receive 1 of 3 VZV modRNA vaccine candidates (different construct, different dose levels and different formulation \[frozen or freeze dry powder\]) or the approved shingles vaccine intramuscularly. Participants will be assigned in 1 of 14 groups in the study. Vaccination will be given either as a 2-dose series using one of two dosing schedules (either 2-months apart or 6-months apart), or (in one of the groups), as a single VZV modRNA vaccine at the first vaccination visit and saline at the second vaccination visit. Participants will take part in this study for 8 to 12 months depending on the group they are assigned to. Some group(s) will continue into persistence-of-immunity (overtime assessment of effect of vaccine) portion of the study. Those participants assigned to these selected groups will be involved in the study for up to 5 years. Substudy B: This substudy is the Phase 2 portion of the study. In this part of the study, participants will receive either VZV modRNA vaccine at selected dose level/schedule/formulation or approved shingles vaccine. This selection will be determined from Substudy A. Participants will be involved in this study for up to 5 years.

Medical Condition
  • Shingles
    • Trial Drug
  • Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
    • See more
  • Candidate 1: PF-07915234: VZV modRNA Suspension for Injection
  • Candidate 2: PF-07921188: VZV modRNA Suspension for Injection
  • Candidate 3: PF-07921186: VZV modRNA Suspension for Injection
  • Shingrix
  • Selected Vaccine Candidate group (Dose level, Schedule)
  • Shingrix - SSB
  • Candidate 2: PF-07921188: VZV modRNA Powder for Suspension for Injection
    • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    900
    Estimated Trial Date
    Jan 2023 - Nov 2025

    Trial Participant Requirements

    Age
    50 - 69 Years
    Sex
    Female & Male
    Healthy Volunteers
    Yes

    Trial Locations

    Location
    Status
    Location
    Tri-City Cardiology
    Gilbert, Arizona, United States, 85233
    Status
    Location
    Aventiv Research Inc.
    Mesa, Arizona, United States, 85206
    Status
    Location
    Stanford University Medical Center
    Palo Alto, California, United States, 94304
    Status
    Location
    Diablo Clinical Research, Inc.
    Walnut Creek, California, United States, 94598
    Status
    Location
    Cardiology Associates of Fairfield County
    Stamford, Connecticut, United States, 06905
    Status
    Location
    Stamford Therapeutics Consortium
    Stamford, Connecticut, United States, 06905
    Status