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TERMINATED
NCT05703607
PHASE1/PHASE2

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection

Intramuscular injection

BIOLOGICAL

Candidate 1: PF-07915234: VZV modRNA Suspension for Injection

Intramuscular injection

BIOLOGICAL

Candidate 2: PF-07921188: VZV modRNA Suspension for Injection

Intramuscular injection

BIOLOGICAL

Candidate 3: PF-07921186: VZV modRNA Suspension for Injection

Intramuscular injection

BIOLOGICAL

Shingrix

Intramuscular injection

BIOLOGICAL

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