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

April 2, 2024 updated by: ModernaTX, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

365

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35218
        • Accel Clinical Sites Network - Cahaba Medical Care
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research
    • California
      • Beverly Hills, California, United States, 90211
        • Cedars-Sinai Medical Center/Carbon Health
      • San Diego, California, United States, 92120
        • Acclaim Clinical Research
    • Florida
      • Lake City, Florida, United States, 32055
        • Multi-Specialty Research Associates, Inc.
      • Miami, Florida, United States, 33173
        • Suncoast Research Associates, LLC
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin-Trials (JCCT)
      • Newton, Kansas, United States, 67114
        • Alliance for Multispecialty Research, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70125
        • Research Works
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Fenway Health
    • Michigan
      • Southfield, Michigan, United States, 48076
        • DM Clinical Research
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Velocity Clinical Research
      • Norfolk, Nebraska, United States, 68701
        • Velocity Clinical Research
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • M3 Wake Research, Inc.
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Velocity Clinical Research Cleveland
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Velocity Clinical Research, Austin
      • Fort Worth, Texas, United States, 76107
        • Helios CR, Inc Fort Worth
      • Houston, Texas, United States, 77081
        • DM Clinical Research
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • Tomball, Texas, United States, 77064
        • DM Clinical Research
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington Virology Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Biological: mRNA-1608
Sterile liquid for injection
Experimental: 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).
Biological: mRNA-1608
Sterile liquid for injection
Experimental: 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).
Biological: mRNA-1608
Sterile liquid for injection
Other: BEXSERO
Participants will receive 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57).
Biological: BEXSERO
A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 85 (28 days after each injection)
Up to Day 85 (28 days after each injection)
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame: Up to Day 64 (7 days after each injection)
Up to Day 64 (7 days after each injection)
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Day 1 to Day 393 (end of study [EoS])
Day 1 to Day 393 (end of study [EoS])
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame: Day 1 to Day 393 (EoS)
Day 1 to Day 393 (EoS)
Number of Participants with AEs Leading to Discontinuation From Study
Time Frame: Day 1 to Day 393 (EoS)
Day 1 to Day 393 (EoS)
Number of Participants with Medically-Attended AEs (MAAEs)
Time Frame: Day 1 through 6 months after last study injection (Day 225)
Day 1 through 6 months after last study injection (Day 225)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection
Time Frame: Day 71 to Day 225
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
Time Frame: Day 71 to Day 393
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)
Time Frame: Baseline (Day -27 to Day 1), Day 85 to Day 113
To calculate the 'Change from Baseline', the herpes lesion rate during the timeframe of Day 85 to Day 113 will be compared against the herpes lesion rate during the timeframe of Day -27 to Day 1 (Baseline).
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)
Time Frame: Baseline (Day -27 to Day 1), Day 197 to Day 225
To calculate the 'Change from Baseline', the herpes lesion rate during the timeframe of Day 197 to Day 225 will be compared against the herpes lesion rate during the timeframe of Day -27 to Day 1 (Baseline).
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)
Time Frame: Baseline (Day -27 to Day 1), Day 85 to Day 113
To calculate the 'Change from Baseline', the HSV-2 genital shedding rate during the timeframe of Day 85 to Day 113 will be compared against the HSV-2 genital shedding rate during the timeframe of Day -27 to Day 1 (Baseline).
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 HSV-2 Genital Shedding Rate (Proportion of HSV-2 DNA Positive Anogenital Swabs)
Time Frame: Baseline (Day -27 to Day 1), Day 197 to Day 225
To calculate the 'Change from Baseline', the HSV-2 genital shedding rate during the timeframe of Day 197 to Day 225 will be compared against the HSV-2 genital shedding rate during the timeframe of Day -27 to Day 1 (Baseline).
Baseline (Day -27 to Day 1), Day 197 to Day 225
Geometric Mean Titer (GMT) of mRNA-1608 Antigen-Specific Binding Antibodies (bAbs) at 1 and 6 Months After the Second Study Injection
Time Frame: Days 85 and 225
Days 85 and 225
Geometric Mean Fold Rise (GMFR) of mRNA-1608 Antigen-Specific bAbs From Baseline to 1 and 6 Months After the Second Study Injection
Time Frame: Baseline (Day 1), Days 85 and 225
Baseline (Day 1), Days 85 and 225
Number of Participants With Vaccine Seroresponse
Time Frame: Baseline (Day 1), Days 85 and 225
Seroresponse is defined by an increase in HSV-2 bAb levels at Day 85 and Day 225 ≥4-fold if baseline level is above the lower level of quantitation (LLOQ) or ≥4 × LLOQ if baseline bAb level is <LLOQ prior to study injection.
Baseline (Day 1), Days 85 and 225

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Estimated)

June 4, 2025

Study Completion (Estimated)

June 4, 2025

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1608-P101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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