TerminatedPhase 1/2

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

Stopped: Strategic decision made by the company

United States484 participantsStarted 2023-01-25

Plain-language 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.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female participants 50 through 69 years of age (inclusive) at the time of consent.

Exclusion criteria

. 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
. Male or female participants 50 through 69 years of age (inclusive) at the time of consent.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SSA: Percentage of participants reporting local reactions

Timeframe: For 7 days after Vaccination 1 and Vaccination 2

SSA: Percentage of participants reporting systemic events

Timeframe: For 7 days after Vaccination 1 and Vaccination 2

SSA: Percentage of participants reporting adverse events

Timeframe: From Vaccination 1 to 4 weeks after last vaccination

SSA: Percentage of participants reporting serious adverse events

Timeframe: From Vaccination 1 to 6 months after the last study vaccination

SSA: Percentage of participants reporting medically attended adverse event

Timeframe: From Vaccination 1 to 6 months after the last study vaccination

SSA: Percentage of participants with abnormal hematology and chemistry laboratory assessments

Timeframe: 3 days and 1 week after each vaccination

SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities

Trial details

NCT IDNCT05703607

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-23

View on ClinicalTrials.gov More Shingles trials

Plain-language summary

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female participants 50 through 69 years of age (inclusive) at the time of consent.

Exclusion criteria

. 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
. Male or female participants 50 through 69 years of age (inclusive) at the time of consent.
. 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.

What they're measuring

SSA: Percentage of participants reporting local reactions

Timeframe: For 7 days after Vaccination 1 and Vaccination 2

SSA: Percentage of participants reporting systemic events

Timeframe: For 7 days after Vaccination 1 and Vaccination 2

SSA: Percentage of participants reporting adverse events

Timeframe: From Vaccination 1 to 4 weeks after last vaccination

SSA: Percentage of participants reporting serious adverse events

Timeframe: From Vaccination 1 to 6 months after the last study vaccination

SSA: Percentage of participants reporting medically attended adverse event

Timeframe: From Vaccination 1 to 6 months after the last study vaccination

SSA: Percentage of participants with abnormal hematology and chemistry laboratory assessments

Timeframe: 3 days and 1 week after each vaccination

SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities