A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes

Last updated: September 23, 2024
Sponsor: ModernaTX, Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Herpes Simplex Infections

Genital Herpes

Treatment

BEXSERO

mRNA-1608

Clinical Study ID

NCT06033261
mRNA-1608-P101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to generate safety and immunogenicity data and establish a proof-of-concept of clinical benefit of the mRNA-1608 vaccine candidate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has a diagnosis of genital HSV-2 infection for at least 1 year beforethe 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 nomore than 9 reported genital herpes recurrences in the 12 months preceding theScreening Visit, or if currently on suppressive therapy, prior to initiation ofsuppressive therapy.

  • Willing to refrain from taking suppressive antiviral therapy from the ScreeningVisit 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, adequatecontraception, and not currently breastfeeding.

Exclusion

Exclusion Criteria:

  • Prior immunization with a vaccine containing HSV antigens.

  • History of any form of ocular HSV infection, HSV-related erythema multiforme, orHSV-related neurological complications.

  • History of genital HSV-1 infection.

  • History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) types 1or 2 (HIV-1, HIV-2).

  • Reported history of anaphylaxis or severe hypersensitivity reaction after receipt ofany mRNA vaccine(s) or any components of the mRNA vaccines.

  • Previously received BEXSERO or other vaccine to prevent serogroup B meningococcaldisease (also known as meningitis B).

  • History of allergic disease or reactions likely to be exacerbated by any componentof BEXSERO vaccine.

  • Has received or plans to receive any licensed or authorized vaccine, includingCOVID-19 vaccines, ≤ 28 days prior to the first study injection (Day 1), or plans toreceive a licensed or authorized vaccine within 28 days before or after studyinjection with the exception of licensed influenza vaccines, which may be receivedmore than 14 days before or after any study injection.

Note: Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 365
Treatment Group(s): 2
Primary Treatment: BEXSERO
Phase: 1/2
Study Start date:
September 06, 2023
Estimated Completion Date:
April 11, 2025

Study Description

Participants with a history of recurrent genital herpes will be randomly assigned in a 1:1:1:1 ratio to receive mRNA-1608 at 1 of the 3 dose levels or control (BEXSERO) administered as 2 doses at 0 and 2 months (Day 1 and Day 57).

Connect with a study center

  • Accel Clinical Sites Network - Cahaba Medical Care

    Birmingham, Alabama 35218
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Noble Clinical Research

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Cedars-Sinai Medical Center/Carbon Health

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    Riverside, California 92503
    United States

    Site Not Available

  • Acclaim Clinical Research

    San Diego, California 92120
    United States

    Site Not Available

  • Multi-Specialty Research Associates, Inc.

    Lake City, Florida 32055
    United States

    Site Not Available

  • Multi-Therapeutic Research Associates, Inc.

    Lake City, Florida 32055
    United States

    Site Not Available

  • Suncoast Research Associates, LLC

    Miami, Florida 33173
    United States

    Site Not Available

  • University of Illinois Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Johnson County Clin-Trials (JCCT)

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas 67114
    United States

    Site Not Available

  • Heartland Research Associates LLC

    Newton, Kansas 67114
    United States

    Site Not Available

  • Research Works

    New Orleans, Louisiana 70125
    United States

    Site Not Available

  • Fenway Health

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • DM Clinical Research

    Southfield, Michigan 48076
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • The Center for Pharmaceutical Research

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Velocity Clinical Research

    Grand Island, Nebraska 68803
    United States

    Site Not Available

  • Velocity Clinical Research

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Rochester Clinical Research

    Rochester, New York 14609
    United States

    Site Not Available

  • UNC Institute for Global Health and Infectious Diseases

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina (UNC) - Kidney Center (UNCKC)

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • M3 Wake Research, Inc.

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Velocity Clinical Research Cleveland

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Velocity Clinical Research, Austin

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • Helios CR, Inc Fort Worth

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • DM Clinical Research

    Houston, Texas 77081
    United States

    Site Not Available

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77064
    United States

    Site Not Available

  • Texas Center for Drug Development, INC

    Tomball, Texas 77064
    United States

    Site Not Available

  • Health Research of Hampton Roads

    Newport News, Virginia 23606
    United States

    Site Not Available

  • University of Washington Virology Research Clinic

    Seattle, Washington 98104
    United States

    Site Not Available

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