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
A Phase 1/2, Randomized, Observer-Blind, Controlled, Dose-Ranging Study of mRNA-1608, an HSV-2 Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes
1 other identifier
interventional
365
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2023
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2023
CompletedStudy Start
First participant enrolled
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2025
CompletedMay 8, 2025
May 1, 2025
1.6 years
September 5, 2023
May 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Up to Day 64 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 85 (28 days after each injection)
Number of Participants with Serious Adverse Events (SAEs)
Day 1 to Day 393 (end of study [EoS])
Number of Participants with Adverse Events of Special Interest (AESIs)
Day 1 to Day 393 (EoS)
Number of Participants with AEs Leading to Discontinuation From Study
Day 1 to Day 393 (EoS)
Number of Participants with Medically-Attended AEs (MAAEs)
Day 1 through 6 months after last study injection (Day 225)
Secondary Outcomes (9)
Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection
Day 71 to Day 225
Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection
Day 71 to Day 393
Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in Genital Herpes Lesion Rate (Proportion of Days With Lesions Present)
Baseline (Day -27 to Day 1), Day 85 to Day 113
Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in Genital Herpes Lesion Rate (Proportion of Days With Lesions Present)
Baseline (Day -27 to Day 1), Day 197 to Day 225
Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Proportion of HSV-2 Deoxyribonucleic acid [DNA] Positive Anogenital Swabs)
Baseline (Day -27 to Day 1), Day 85 to Day 113
- +4 more secondary outcomes
Study Arms (4)
mRNA-1608 Dose A
EXPERIMENTALParticipants 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 Dose B
EXPERIMENTALParticipants 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 Dose C
EXPERIMENTALParticipants 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).
BEXSERO
OTHERParticipants will receive 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (23)
Accel Clinical Sites Network - Cahaba Medical Care
Birmingham, Alabama, 35218, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Cedars-Sinai Medical Center/Carbon Health
Beverly Hills, California, 90211, United States
Acclaim Clinical Research
San Diego, California, 92120, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
Suncoast Research Associates, LLC
Miami, Florida, 33173, United States
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114, United States
Research Works
New Orleans, Louisiana, 70125, United States
Fenway Health
Boston, Massachusetts, 02215, United States
DM Clinical Research
Southfield, Michigan, 48076, United States
Velocity Clinical Research
Grand Island, Nebraska, 68803, United States
Velocity Clinical Research
Norfolk, Nebraska, 68701, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
Velocity Clinical Research Cleveland
Beachwood, Ohio, 44122, United States
Velocity Clinical Research, Austin
Cedar Park, Texas, 78613, United States
Helios CR, Inc Fort Worth
Fort Worth, Texas, 76107, United States
DM Clinical Research
Houston, Texas, 77081, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
DM Clinical Research
Tomball, Texas, 77064, United States
Health Research of Hampton Roads
Newport News, Virginia, 23606, United States
University of Washington Virology Research Clinic
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2023
First Posted
September 13, 2023
Study Start
September 6, 2023
Primary Completion
April 25, 2025
Study Completion
April 25, 2025
Last Updated
May 8, 2025
Record last verified: 2025-05