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A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults
Sponsor: Pfizer
Summary
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 50 through 85 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 10 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 was determined from data collected in Substudy A. Participants will be involved in this study for up to 5 years.
Official title: A PHASE 1/2 RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST VARICELLA ZOSTER VIRUS IN HEALTHY INDIVIDUALS
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
484
Start Date
2023-01-25
Completion Date
2025-09-23
Last Updated
2026-05-04
Healthy Volunteers
Yes
Conditions
Interventions
Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
Intramuscular injection
Candidate 1: PF-07915234: VZV modRNA Suspension for Injection
Intramuscular injection
Candidate 2: PF-07921188: VZV modRNA Suspension for Injection
Intramuscular injection
Candidate 3: PF-07921186: VZV modRNA Suspension for Injection
Intramuscular injection
Shingrix
Intramuscular injection
Candidate 2: PF-07921188: VZV modRNA Powder for Suspension for Injection
Intramuscular injection
Locations (35)
Tri-City Cardiology
Gilbert, Arizona, United States
Aventiv Research Inc.
Mesa, Arizona, United States
Stanford University Medical Center
Palo Alto, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
GW Vaccine Research Unit
Washington D.C., District of Columbia, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
West Valley Cardiology Services
Meridian, Idaho, United States
Solaris Clinical Research
Meridian, Idaho, United States
University of Iowa
Iowa City, Iowa, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
Centennial Medical Group
Columbia, Maryland, United States
Associates in Cardiology, PA
Silver Spring, Maryland, United States
C.S. Mott Clinical Research Center (CRC)
Detroit, Michigan, United States
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States
Quality Clinical Research
Omaha, Nebraska, United States
University of Nevada School of Medicine - Reno
Reno, Nevada, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
IMA Clinical Research
Albuquerque, New Mexico, United States
NYU Langone Health
New York, New York, United States
Tisch Hospital
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Wilmington Health, PLLC (Cardiologist)
Wilmington, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
Columbus Cardiovascular Associates, Inc.
Columbus, Ohio, United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, United States