> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-a-modified-rna-vaccine-against-3e26c431-af2d-4342-bc23-54831513cb43 > Record changed: 2026-10-29 # A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults NCT05703607 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) Participants 484 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) Start date 2023-01-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) Number of sites 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Short title** A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Reason stopped** Strategic decision made by the company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Dates **Completion date** 2025-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **First posted** 2023-01-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Registry last updated** 2026-05-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Primary completion date** 2025-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Start date** 2023-01-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Size and sites **Actual participants** 484 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Participants** 484 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Protocol amendments** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Number of sites** 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Identifiers **Registry ID** NCT05703607 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **ClinicalTrials.gov ID** NCT05703607 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Prevention **Masking** Quadruple masking **Masking description** SSA: Observer-blinded, Sponsor Open label SSB: Observer-blinded **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Outcomes ### Primary outcomes 1. SSA: Percentage of participants reporting local reactions Timeframe: For 7 days after Vaccination 1 and Vaccination 2 Pain at the injection site, redness, and swelling as self-reported in electronic diaries. 2. SSA: Percentage of participants reporting systemic events Timeframe: For 7 days after Vaccination 1 and Vaccination 2 Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries 3. SSA: Percentage of participants reporting adverse events Timeframe: From Vaccination 1 to 4 weeks after last vaccination As elicited by investigational site staff 4. SSA: Percentage of participants reporting serious adverse events Timeframe: From Vaccination 1 to 6 months after the last study vaccination As elicited by investigational site staff 5. SSA: Percentage of participants reporting medically attended adverse event Timeframe: From Vaccination 1 to 6 months after the last study vaccination As elicited by investigational site staff 6. SSA: Percentage of participants with abnormal hematology and chemistry laboratory assessments Timeframe: 3 days and 1 week after each vaccination As measured at the central laboratory 7. SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities Timeframe: 3 days and 1 week after each vaccination ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist 8. SSA: Percentage of participants with abnormal troponin I laboratory values Timeframe: 3 days and 1 week after each vaccination as measured at the central laboratory 9. SSB: Percentage of participants reporting local reactions Timeframe: For 7 days after Vaccination 1 and Vaccination 2 Pain at the injection site, redness, and swelling as self-reported in electronic diaries. 10. SSB: Percentage of participants reporting systemic events Timeframe: For 7 days after Vaccination 1 and Vaccination 2 Fever, fatigue, headache, chills, vomiting, diarrhea, muscle pain, and joint pain, as self-reported in electronic diaries 11. SSB: Percentage of participants reporting adverse events Timeframe: From Vaccination 1 to 4 weeks after last vaccination As elicited by investigational site staff 12. SSB: Percentage of participants reporting serious adverse events Timeframe: From Vaccination 1 to 6 months after the last study vaccination As elicited by investigational site staff 13. SSB: Percentage of participants reporting medically attended adverse events Timeframe: From Vaccination 1 to 6 months after the last study vaccination As elicited by investigational site staff ### Secondary outcomes 1. SSA: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant Timeframe: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination As measured at the central laboratory 2. SSA: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants Timeframe: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination As measured at the central laboratory 3. SSA: Proportion of evaluable immunogenicity participants with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint Timeframe: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination As measured at the central laboratory 4. SSB: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant Timeframe: At baseline (before vaccination 1), at 4-weeks after each vaccination and 6-months after last vaccination As measured at the central laboratory 5. SSB: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants Timeframe: At baseline (before vaccination 1), at 4-weeks after each vaccination and 6-months after last vaccination As measured at the central laboratory 6. SSB: Proportion of evaluable immunogenicity participants with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint Timeframe: At baseline (before vaccination 1), at 4-weeks after each vaccination and 6-months after last vaccination As measured at the central laboratory Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 50 Years **Maximum age** 85 Years **Healthy volunteers** Yes Substudy A: Group 1 to Group 10 ### Inclusion criteria 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 Substudy A: Group 11 to Group 14 ### Inclusion criteria 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 ### Exclusion criteria 1. History of HZ (shingles). 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: ### Inclusion criteria 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 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Sites - Tri-City CardiologyGilbert, United States - Aventiv Research Inc.Mesa, United States - Stanford University Medical CenterPalo Alto, United States - Diablo Clinical Research, Inc.Walnut Creek, United States - GW Medical Faculty AssociatesWashington D.C., United States - GW Vaccine Research UnitWashington D.C., United States - Proactive Clinical Research,LLCFort Lauderdale, United States - Acevedo Clinical Research AssociatesMiami, United States - East-West Medical Research InstituteHonolulu, United States - West Valley Cardiology ServicesMeridian, United States - Solaris Clinical ResearchMeridian, United States - University of IowaIowa City, United States - Johnson County Clinical TrialsLenexa, United States - Centennial Medical GroupColumbia, United States - Associates in Cardiology, PASilver Spring, United States - C.S. Mott Clinical Research Center (CRC)Detroit, United States - Henry Ford St. John HospitalGrosse Pointe Woods, United States - Velocity Clinical Research, NorfolkNorfolk, United States - Quality Clinical ResearchOmaha, United States - University of Nevada School of Medicine - RenoReno, United States - South Jersey Infectious DiseaseSomers Point, United States - IMA Clinical ResearchAlbuquerque, United States - NYU Langone HealthNew York, United States - Tisch HospitalNew York, United States - Icahn School of Medicine at Mount SinaiNew York, United States And 10 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C5031001) ### Other registry identifiers - NCT05703607 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05703607) ## Related records ### Drugs (2) - [Insulin zinc](https://trialight.com/data/asset/insulin-zinc-463180c5-b6f9-4313-aaa6-59cbb2adbfe5.md) - [Varicella zoster virus envelope glycoprotein E](https://trialight.com/data/asset/varicella-zoster-virus-envelope-glycoprotein-e-ff6f0103-e6e7-4f17-9aed-0ca05c8633ef.md) ### Collaborators (1) - [BioNTech SE](https://trialight.com/data/company/biontech-se-85cb6dcc-6a40-467f-aab1-af1123099f83.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (2) - [Chickenpox](https://trialight.com/data/condition/chickenpox-4213f806-c779-5b01-9e52-7179e9edebeb.md) - [Herpes zoster](https://trialight.com/data/condition/herpes-zoster-b5c04cf4-ae28-5154-8254-f4f1fde4c3c9.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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