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Can mRNA technology outsmart shingles? a new vaccine trial aims to find out

NCT ID NCT05701800

Vaccine Sponsor: ModernaTX, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests an experimental mRNA vaccine, mRNA-1468, to see if it can safely prevent shingles in healthy adults aged 50 and older. Participants receive either the new vaccine, a placebo, or an existing shingles vaccine (Shingrix) to compare safety and immune response. The study aims to find the right dose and assess how well the vaccine triggers the body's defenses against the virus that causes shingles.

What this could mean

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

Active substance
mRNA-1468, an experimental mRNA-based vaccine designed to prevent herpes zoster (shingles)
What this could lead to
If successful, this could lead to a new mRNA-based vaccine option for preventing shingles, potentially offering better protection or convenience compared to existing vaccines.
What could go wrong
This is an early-phase trial, so the vaccine may not prove safe or effective. Possible side effects include injection-site reactions and systemic symptoms like fever or fatigue.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

659 people

The number who actually took part.

Started

Jan 2023

Finished

Dec 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 years and older

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.

Inclusion Criteria: * Part 1: Is an adult 50 years of age or older at the time of consent. Part 2: Is an adult 50-69 years of age at the time of consent. * Has a body mass index of 18 to \<40 kilograms/meter squared at the Screening Visit. * Females of childbearing potential: have a negative pregnancy test at the Screening Visit and on the day of the first vaccination (Day 1); have practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1; have agreed to continue adequate contraception through 3 months following vaccine administration; are not currently breastfeeding. Exclusion Criteria: * Has a history of HZ within the past 10 years. * Has been previously vaccinated against varicella or HZ. * Is acutely ill or febrile * Body temperature ≥38.0°Celsius/100.4°Fahrenheit 72 hours prior to or at the Screening Visit or on Day 1. Participants meeting this criterion may be rescheduled within the allowed window. * Has a current or previous diagnosis of congenital or acquired immunodeficiency, immunocompromizing/immunosuppressive condition, asplenia, or recurrent severe infections. Certain immune-mediated conditions that are well controlled and stable (for example, Hashimoto thyroiditis) as well as those that do not require systemic immunosuppressive therapy (for example, asthma, psoriasis, or vitiligo) may be permitted at the discretion of the Investigator. * Has a dermatologic condition that could affect local solicited adverse reaction assessments (for example, tattoos, psoriasis patches affecting skin over the deltoid areas). * Has any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. * Has a history of myocarditis, pericarditis, or myopericarditis. * Has a reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines. * Has received systemic immunosuppressants for \>14 days in total within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, intra-articular and topical steroids are allowed. * Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, Infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study. Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

herpes zoster prevention target

As listed by the trial registrant

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

Herpes zoster

Contacts and locations

Locations

  • Centricity Research

    Columbus, Georgia, 31904, United States

  • Clinical Trials of Florida, LLC

    Miami, Florida, 33186, United States

  • DM Clinical Research

    Tomball, Texas, 77375, United States

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107, United States

  • DM Clinical Research- River Forest

    River Forest, Illinois, 60305, United States

  • Florida Pulmonary Research Institute, LLC

    Winter Park, Florida, 32789, United States

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Gadolin Research

    Beaumont, Texas, 77702, United States

  • Great Lakes

    Chicago, Illinois, 60640, United States

  • Johnson County Clin-Trials (JCCT)

    Lenexa, Kansas, 66219, United States

  • LinQ Research, LLC

    Houston, Texas, 77087, United States

  • Meridian Clinical Research - Dakota Dunes

    Sioux City, Iowa, 51106, United States

  • Meridien Research

    Lakeland, Florida, 33805, United States

  • NOLA Research Works

    New Orleans, Louisiana, 70115, United States

  • Research Works San Juan

    San Juan, 00907, Puerto Rico

  • Tekton Research

    Austin, Texas, 78745, United States

  • Tekton Research, Inc - Longmont Center

    Longmont, Colorado, 80501, United States

  • Velocity Clinical Research - Medford

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research - Westlake

    Los Angeles, California, 90057, United States

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421, United States

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