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MRNA shingles vaccine trial ends early – what we know

NCT ID NCT05703607

Vaccine Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested several experimental mRNA vaccines against shingles in healthy adults aged 50 to 85. The goal was to check safety and immune response compared to the current shingles vaccine, Shingrix. The trial was terminated early, so results are limited, but the data may help develop future shingles vaccines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA vaccine against varicella zoster virus
What this could lead to
If successful, this could lead to a new mRNA-based shingles vaccine that is easier to produce and store than current options.
What could go wrong
The trial was terminated early, so we have limited data. It is still in early phases (1/2), meaning safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

484 people

The number who actually took part.

Started

Jan 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chickenpox human disease herpes zoster prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Herpes zoster infection HUMAN Shingles

Contacts and locations

Locations

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401, United States

  • Acevedo Clinical Research Associates

    Miami, Florida, 33142, United States

  • Associates in Cardiology, PA

    Silver Spring, Maryland, 20910, United States

  • Aventiv Research Inc.

    Mesa, Arizona, 85206, United States

  • C.S. Mott Clinical Research Center (CRC)

    Detroit, Michigan, 48201, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Centennial Medical Group

    Columbia, Maryland, 21045, United States

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213, United States

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229, United States

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas, 78229, United States

  • Columbus Cardiovascular Associates, Inc.

    Columbus, Ohio, 43213, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Tomball, Texas, 77375, United States

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814, 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

  • Henry Ford St. John Hospital

    Grosse Pointe Woods, Michigan, 48236, United States

  • IMA Clinical Research

    Albuquerque, New Mexico, 87109, United States

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Johnson County Clinical Trials

    Lenexa, Kansas, 66219, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida, 33308, United States

  • Quality Clinical Research

    Omaha, Nebraska, 68114, United States

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609, United States

  • Solaris Clinical Research

    Meridian, Idaho, 83646, United States

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244, United States

  • Stanford University Medical Center

    Palo Alto, California, 94304, United States

  • Tisch Hospital

    New York, New York, 10016, United States

  • Tri-City Cardiology

    Gilbert, Arizona, 85233, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Nevada School of Medicine - Reno

    Reno, Nevada, 89557, United States

  • Velocity Clinical Research, Norfolk

    Norfolk, Nebraska, 68701, United States

  • West Valley Cardiology Services

    Meridian, Idaho, 83642, United States

  • Wilmington Health, PLLC (Cardiologist)

    Wilmington, North Carolina, 28401, United States

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