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
303
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
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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
CompletedResults Posted
Study results publicly available
May 8, 2026
CompletedMay 8, 2026
April 1, 2026
1.6 years
September 5, 2023
April 17, 2026
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants With Solicited Local and Systemic ARs
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to Day 64 (Within 7 days after study vaccination)
Number of Participants With Unsolicited Adverse Events (AEs)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to Day 85 (Up to 28 days after study vaccination)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor were required. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through Day 393
Number of Participants With Medically Attended AEs (MAAEs)
A MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through Day 393
Secondary Outcomes (9)
Number of Genital Herpes Recurrence Episode Per Participant, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection
Day 71 up to Day 225
Number of Genital Herpes Recurrence Episode Per Participant, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection
Day 71 up 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 (Percentage of Days With Lesions Present)
Baseline (Day -27 to Day 1), 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 (Percentage of Days With Lesions Present)
Baseline (Day -27 to Day 1), 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 (Percentage of HSV-2 Deoxyribonucleic Acid [DNA] Positive Anogenital Swabs)
Baseline (Day -27 to Day 1), 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)
Results Point of Contact
- Title
- Moderna WeCare Team
- Organization
- ModernaTX, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
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, 2026
Results First Posted
May 8, 2026
Record last verified: 2026-04