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A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults
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
2 other identifiers
interventional
484
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2023
Typical duration for phase_1
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2023
CompletedStudy Start
First participant enrolled
January 25, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2025
CompletedMay 4, 2026
April 1, 2026
2.7 years
January 19, 2023
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
SSA: Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling as self-reported in electronic diaries.
For 7 days after Vaccination 1 and Vaccination 2
SSA: Percentage of participants reporting systemic events
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
For 7 days after Vaccination 1 and Vaccination 2
SSA: Percentage of participants reporting adverse events
As elicited by investigational site staff
From Vaccination 1 to 4 weeks after last vaccination
SSA: Percentage of participants reporting serious adverse events
As elicited by investigational site staff
From Vaccination 1 to 6 months after the last study vaccination
SSA: Percentage of participants reporting medically attended adverse event
As elicited by investigational site staff
From Vaccination 1 to 6 months after the last study vaccination
SSA: Percentage of participants with abnormal hematology and chemistry laboratory assessments
As measured at the central laboratory
3 days and 1 week after each vaccination
SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
3 days and 1 week after each vaccination
SSA: Percentage of participants with abnormal troponin I laboratory values
as measured at the central laboratory
3 days and 1 week after each vaccination
SSB: Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling as self-reported in electronic diaries.
For 7 days after Vaccination 1 and Vaccination 2
SSB: Percentage of participants reporting systemic events
Fever, fatigue, headache, chills, vomiting, diarrhea, muscle pain, and joint pain, as self-reported in electronic diaries
For 7 days after Vaccination 1 and Vaccination 2
SSB: Percentage of participants reporting adverse events
As elicited by investigational site staff
From Vaccination 1 to 4 weeks after last vaccination
SSB: Percentage of participants reporting serious adverse events
As elicited by investigational site staff
From Vaccination 1 to 6 months after the last study vaccination
SSB: Percentage of participants reporting medically attended adverse events
As elicited by investigational site staff
From Vaccination 1 to 6 months after the last study vaccination
Secondary Outcomes (6)
SSA: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
SSA: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
SSA: Proportion of evaluable immunogenicity participants with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
SSB: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant
At baseline (before vaccination 1), at 4-weeks after each vaccination and 6-months after last vaccination
SSB: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants
At baseline (before vaccination 1), at 4-weeks after each vaccination and 6-months after last vaccination
- +1 more secondary outcomes
Study Arms (14)
SubStudy A (SSA): Group 1
EXPERIMENTALCandidate 1, Dose Level 1, lyophilized, 0, 2 months schedule
SSA: Group 2
EXPERIMENTALCandidate 1, Dose Level 2, lyophilized, 0, 2 months schedule
SSA: Group 3
EXPERIMENTALCandidate 1, Dose Level 3, lyophilized, 0, 2 months schedule
SSA: Group 4
EXPERIMENTALCandidate 1, Dose Level 2, frozen, 0, 2 months schedule
SSA: Group 5
EXPERIMENTALCandidate 1, Dose Level 2, Frozen, 0, 6 months schedule
SSA: Group 6
EXPERIMENTALCandidate 2, frozen, 0, 2 months schedule
SSA: Group 7
EXPERIMENTALCandidate 3, Frozen, 0, 2 months schedule
SSA: Group 8
ACTIVE COMPARATORShingrix, 0, 2 months schedule
SSA: Group 9
ACTIVE COMPARATORShingrix, 0, 6 months schedule
SSA: Group 10
EXPERIMENTALCandidate 1, Dose level 4, lyophilized, 0, 6 months schedule (saline at month 6)
Substudy B (SSB): Group 1
EXPERIMENTALCandidate 2, Dose level 3, lyophilized, 0, 2 months schedule
SSB: Group 2
EXPERIMENTALCandidate 2, Dose level 4, lyophilized, 0, 2 months schedule
SSB: Group 3
EXPERIMENTALCandidate 2, Dose level 4, lyophilized, 0, 2 months schedule (saline at month 2)
SSB: Group 4
ACTIVE COMPARATORShingrix, 0, 2 months schedule
Interventions
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Eligibility Criteria
You may qualify if:
- Male or female participants 50 through 69 years of age (inclusive) at the time of consent.
- Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol
- Substudy A: Group 11 to Group 14
- Male or female participants 50 through 69 years of age (inclusive) at the time of consent.
- Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
- Has a body mass index (BMI) between 18 and 35 (inclusive) kg/m2 at the screening visit.
- Substudy A: Group 1 to Group 10
You may not qualify if:
- History of HZ (shingles).
- History of Guillain-Barré syndrome.
- Known infection with HIV, HCV, or HBV.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Women who are pregnant or breastfeeding.
- Prior history of heart disease (eg, heart failure, recent coronary artery disease, cardiomyopathies, pericarditis/myocarditis).
- Previous vaccination with any varicella or HZ vaccine.
- Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
- Any participant who has received or plans to receive an RNA vaccine 28 days prior to Vaccination 1.
- Participation in other interventional studies within 28 days prior to study entry or anticipated involvement through and including 6 months after the last dose of study intervention. Participation in observational studies is permitted.
- Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality; or any abnormal bilirubin or troponin I value.
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- BioNTech SEcollaborator
Study Sites (35)
Tri-City Cardiology
Gilbert, Arizona, 85233, United States
Aventiv Research Inc.
Mesa, Arizona, 85206, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
GW Vaccine Research Unit
Washington D.C., District of Columbia, 20037, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, 33308, United States
Acevedo Clinical Research Associates
Miami, Florida, 33142, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
West Valley Cardiology Services
Meridian, Idaho, 83642, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Johnson County Clinical Trials
Lenexa, Kansas, 66219, United States
Centennial Medical Group
Columbia, Maryland, 21045, United States
Associates in Cardiology, PA
Silver Spring, Maryland, 20910, United States
C.S. Mott Clinical Research Center (CRC)
Detroit, Michigan, 48201, United States
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan, 48236, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
University of Nevada School of Medicine - Reno
Reno, Nevada, 89557, United States
South Jersey Infectious Disease
Somers Point, New Jersey, 08244, United States
IMA Clinical Research
Albuquerque, New Mexico, 87109, United States
NYU Langone Health
New York, New York, 10016, United States
Tisch Hospital
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401, United States
Wilmington Health, PLLC (Cardiologist)
Wilmington, North Carolina, 28401, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213, United States
Columbus Cardiovascular Associates, Inc.
Columbus, Ohio, 43213, United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- SSA: Observer-blinded, Sponsor Open label SSB: Observer-blinded
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2023
First Posted
January 30, 2023
Study Start
January 25, 2023
Primary Completion
September 23, 2025
Study Completion
September 23, 2025
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.