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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

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ClinicalTrials.gov Identifier: NCT06033261
Recruitment Status : Active, not recruiting
First Posted : September 13, 2023
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Genital Herpes Biological: mRNA-1608 Biological: BEXSERO Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 6, 2023
Estimated Primary Completion Date : June 4, 2025
Estimated Study Completion Date : June 4, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Bexsero

Arms and Interventions
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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
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.


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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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 ]
  8. 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 ]
  9. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06033261


Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT06033261    
Other Study ID Numbers: mRNA-1608-P101
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
HSV-2
Herpes Simplex Virus Type 2
HSV-2 vaccine
Genital Herpes
mRNA-1608
Additional relevant MeSH terms:
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Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Communicable Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Genital Diseases, Male
Male Urogenital Diseases