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New mRNA vaccine aims to tame genital herpes recurrences

NCT ID NCT06033261

Disease control 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental mRNA vaccine (mRNA-1608) in 303 healthy adults aged 18 to 55 with recurrent genital herpes caused by HSV-2. The goal was to see if the vaccine is safe and can reduce the number of outbreaks. Participants received different doses of the vaccine or a placebo, and researchers tracked side effects and recurrence episodes over six months.

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

303 people

The number who actually took part.

Started

Sep 2023

Finished

Apr 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

18 to 55 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.

Inclusion Criteria: * Participant has a diagnosis of genital HSV-2 infection for at least 1 year before the Screening Visit. * Seropositive for HSV-2 as determined by Western Blot. * Participant has a history of recurrent genital herpes defined as at least 3 and no more than 9 reported genital herpes recurrences in the 12 months preceding the Screening Visit, or if currently on suppressive therapy, prior to initiation of suppressive therapy. * Willing to refrain from taking suppressive antiviral therapy from the Screening Visit until the end of the study. * Willing to refrain from the use of episodic antiviral therapy during the three 28-day anogenital swabbing periods. Episodic therapy may be used outside the three 28-day swabbing periods. * For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding. Exclusion Criteria: * Prior immunization with a vaccine containing HSV antigens. * History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications. * History of genital HSV-1 infection. * History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) types 1 or 2 (HIV-1, HIV-2). * Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines. * Previously received BEXSERO or other vaccine to prevent serogroup B meningococcal disease (also known as meningitis B). * History of allergic disease or reactions likely to be exacerbated by any component of BEXSERO vaccine. * Has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤ 28 days prior to the first study injection (Day 1), or plans to receive a licensed or authorized vaccine within 28 days before or after study injection with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study injection. Note: Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

genital herpes

As listed by the trial registrant

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

Genital herpes

Contacts and locations

Locations

  • Accel Clinical Sites Network - Cahaba Medical Care

    Birmingham, Alabama, 35218, United States

  • Acclaim Clinical Research

    San Diego, California, 92120, United States

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas, 67114, United States

  • Cedars-Sinai Medical Center/Carbon Health

    Beverly Hills, California, 90211, United States

  • DM Clinical Research

    Southfield, Michigan, 48076, United States

  • DM Clinical Research

    Houston, Texas, 77081, United States

  • DM Clinical Research

    Tomball, Texas, 77064, United States

  • Fenway Health

    Boston, Massachusetts, 02215, United States

  • Health Research of Hampton Roads

    Newport News, Virginia, 23606, United States

  • Helios CR, Inc Fort Worth

    Fort Worth, Texas, 76107, United States

  • Johnson County Clin-Trials (JCCT)

    Lenexa, Kansas, 66219, United States

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612, United States

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida, 32055, United States

  • Noble Clinical Research

    Tucson, Arizona, 85704, United States

  • Research Works

    New Orleans, Louisiana, 70125, United States

  • Rochester Clinical Research

    Rochester, New York, 14609, United States

  • Sun Research Institute

    San Antonio, Texas, 78215, United States

  • Suncoast Research Associates, LLC

    Miami, Florida, 33173, United States

  • University of Washington Virology Research Clinic

    Seattle, Washington, 98104, United States

  • Velocity Clinical Research

    Grand Island, Nebraska, 68803, United States

  • Velocity Clinical Research

    Norfolk, Nebraska, 68701, United States

  • Velocity Clinical Research Cleveland

    Beachwood, Ohio, 44122, United States

  • Velocity Clinical Research, Austin

    Cedar Park, Texas, 78613, United States

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Other studies related to the condition(s) this trial covers.