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
NCT ID: NCT06033261
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
365 participants
INTERVENTIONAL
2023-09-06
2025-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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mRNA-1608 Dose A
Participants will receive 2 intramuscular (IM) injections of mRNA-1608 at Dose Level A, each dose administered at 0 and 2 months (Day 1 and Day 57).
mRNA-1608
Sterile liquid for injection
mRNA-1608 Dose B
Participants will receive 2 IM injections of mRNA-1608 at Dose Level B, each dose administered at 0 and 2 months (Day 1 and Day 57).
mRNA-1608
Sterile liquid for injection
mRNA-1608 Dose C
Participants will receive 2 IM injections of mRNA-1608 at Dose Level C, each dose administered at 0 and 2 months (Day 1 and Day 57).
mRNA-1608
Sterile liquid for injection
BEXSERO
Participants will receive 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57).
BEXSERO
A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.
Interventions
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mRNA-1608
Sterile liquid for injection
BEXSERO
A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Accel Clinical Sites Network - Cahaba Medical Care
Birmingham, Alabama, United States
Noble Clinical Research
Tucson, Arizona, United States
Cedars-Sinai Medical Center/Carbon Health
Beverly Hills, California, United States
Acclaim Clinical Research
San Diego, California, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, United States
Research Works
New Orleans, Louisiana, United States
Fenway Health
Boston, Massachusetts, United States
DM Clinical Research
Southfield, Michigan, United States
Velocity Clinical Research
Grand Island, Nebraska, United States
Velocity Clinical Research
Norfolk, Nebraska, United States
Rochester Clinical Research
Rochester, New York, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
Velocity Clinical Research Cleveland
Beachwood, Ohio, United States
Velocity Clinical Research, Austin
Cedar Park, Texas, United States
Helios CR, Inc Fort Worth
Fort Worth, Texas, United States
DM Clinical Research
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Health Research of Hampton Roads
Newport News, Virginia, United States
University of Washington Virology Research Clinic
Seattle, Washington, United States
Countries
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Other Identifiers
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mRNA-1608-P101
Identifier Type: -
Identifier Source: org_study_id
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