A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults
NCT ID: NCT05703607
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
485 participants
INTERVENTIONAL
2023-01-25
2025-09-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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Substudy B (SSB): Group 1
Candidate 2, Dose level 3, lyophilized, 0, 2 months schedule
Candidate 2: PF-07921188: VZV modRNA Powder for Suspension for Injection
Intramuscular injection
SSB: Group 2
Candidate 2, Dose level 4, lyophilized, 0, 2 months schedule
Candidate 2: PF-07921188: VZV modRNA Powder for Suspension for Injection
Intramuscular injection
SSB: Group 3
Candidate 2, Dose level 4, lyophilized, 0, 2 months schedule (saline at month 2)
Candidate 2: PF-07921188: VZV modRNA Powder for Suspension for Injection
Intramuscular injection
SSB: Group 4
Shingrix, 0, 2 months schedule
Shingrix
Intramuscular injection
SubStudy A (SSA): Group 1
Candidate 1, Dose Level 1, lyophilized, 0, 2 months schedule
Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
Intramuscular injection
SSA: Group 2
Candidate 1, Dose Level 2, lyophilized, 0, 2 months schedule
Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
Intramuscular injection
SSA: Group 3
Candidate 1, Dose Level 3, lyophilized, 0, 2 months schedule
Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
Intramuscular injection
SSA: Group 4
Candidate 1, Dose Level 2, frozen, 0, 2 months schedule
Candidate 1: PF-07915234: VZV modRNA Suspension for Injection
Intramuscular injection
SSA: Group 5
Candidate 1, Dose Level 2, Frozen, 0, 6 months schedule
Candidate 1: PF-07915234: VZV modRNA Suspension for Injection
Intramuscular injection
SSA: Group 6
Candidate 2, frozen, 0, 2 months schedule
Candidate 2: PF-07921188: VZV modRNA Suspension for Injection
Intramuscular injection
SSA: Group 7
Candidate 3, Frozen, 0, 2 months schedule
Candidate 3: PF-07921186: VZV modRNA Suspension for Injection
Intramuscular injection
SSA: Group 8
Shingrix, 0, 2 months schedule
Shingrix
Intramuscular injection
SSA: Group 9
Shingrix, 0, 6 months schedule
Shingrix
Intramuscular injection
SSA: Group 10
Candidate 1, Dose level 4, lyophilized, 0, 6 months schedule (saline at month 6)
Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
Intramuscular injection
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Healthy participants who are determined by clinical assessment, including medical history and clinical judgment of the investigator, to be eligible for inclusion in the study. Note: Known infection with HIV, HCV or HBV is an exclusion in Substudy A.
3. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
4. 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
1. Male or female participants 50 through 69 years of age (inclusive) at the time of consent.
2. Healthy participants who are determined by clinical assessment, including medical history and clinical judgment of the investigator, to be eligible for inclusion in the study. Note: Known infection with HIV, HCV or HBV is an exclusion in Substudy A.
3. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
4. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
5. Has a body mass index (BMI) between 18 and 35 (inclusive) kg/m2 at the screening visit.
Substudy A: Group 1 to Group 10
1. Male or female participants 50 through 85 years of age (inclusive) at the time of consent.
2. Healthy participants who are determined by clinical assessment, including medical history and clinical judgment of the investigator, to be eligible for inclusion in the study.
3. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
4. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
5. Has a BMI between 18 and 35 (inclusive) kg/m2 at the screening visit.
Exclusion Criteria
2. History of Guillain-Barré syndrome.
3. Known infection with HIV, HCV, or HBV.
4. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
5. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
7. 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.
8. Women who are pregnant or breastfeeding.
9. Prior history of heart disease (eg, heart failure, recent coronary artery disease, cardiomyopathies, pericarditis/myocarditis).
10. Previous vaccination with any varicella or HZ vaccine.
11. 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.
12. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
13. Any participant who has received or plans to receive an RNA vaccine 28 days prior to Vaccination 1.
14. 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.
15. 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.
16. Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis/pericarditis or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
17. Participation or planned participation in strenuous or endurance exercise within 7 days before or after each study intervention administration.
18. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
SubStudy B:
1. History of HZ (shingles).
2. History of Guillain-Barré syndrome.
3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
4. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
5. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
6. 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.
7. Women who are pregnant or breastfeeding.
8. Prior history of heart disease (eg, heart failure, recent coronary artery disease, cardiomyopathies, pericarditis, or myocarditis).
9. Previous vaccination with any varicella or HZ vaccine.
10. 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.
11. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
12. Any participant who has received or plans to receive an RNA vaccine 28 days prior to Vaccination 1.
13. 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 is prohibited. Participation in observational studies is permitted.
14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
50 Years
85 Years
ALL
Yes
Sponsors
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BioNTech SE
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05703607
Identifier Type: REGISTRY
Identifier Source: secondary_id
C5031001
Identifier Type: -
Identifier Source: org_study_id
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