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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

Primary Purpose

Genital Herpes

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-1608
BEXSERO
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Herpes focused on measuring HSV-2, Herpes Simplex Virus Type 2, HSV-2 vaccine, Genital Herpes, mRNA-1608

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Noble Clinical ResearchRecruiting
  • Cedars-Sinai Medical Center/Carbon Health
  • Artemis Institute for Clinical Research
  • Acclaim Clinical Research
  • Multi-Therapeutic Research Associates, Inc.
  • Suncoast Research Associates, LLC
  • University of Illinois Medical Center
  • Johnson County Clin-Trials (JCCT)Recruiting
  • Heartland Research Associates LLC
  • Fenway Health
  • The Center for Pharmaceutical Research
  • Velocity Clinical Research
  • Velocity Clinical Research
  • Rochester Clinical Research
  • University of North Carolina (UNC) - Kidney Center (UNCKC)
  • M3 Wake Research, Inc.
  • Lynn Health Science Institute
  • Velocity Clinical Research, AustinRecruiting
  • Helios CR, Inc Fort Worth
  • DM Clinical Research
  • Sun Research Institute
  • Texas Center for Drug Development, INC
  • Health Research of Hampton Roads
  • University of Washington Virology Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

mRNA-1608 Dose A

mRNA-1608 Dose B

mRNA-1608 Dose C

BEXSERO

Arm Description

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).

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).

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).

Participants will receive 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57).

Outcomes

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Adverse Events of Special Interest (AESIs)
Number of Participants with AEs Leading to Discontinuation From Study
Number of Participants with Medically-Attended AEs (MAAEs)

Secondary Outcome Measures

Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection
Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection
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)
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).
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)
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).
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)
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).
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)
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).
Geometric Mean Titer (GMT) of mRNA-1608 Antigen-Specific Binding Antibodies (bAbs) at 1 and 6 Months After the Second Study Injection
Geometric Mean Fold Rise (GMFR) of mRNA-1608 Antigen-Specific bAbs From Baseline to 1 and 6 Months After the Second Study Injection
Number of Participants With Vaccine Seroresponse
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.

Full Information

First Posted
September 5, 2023
Last Updated
September 11, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06033261
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
June 4, 2025 (Anticipated)
Study Completion Date
June 4, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
Keywords
HSV-2, Herpes Simplex Virus Type 2, HSV-2 vaccine, Genital Herpes, mRNA-1608

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1608 Dose A
Arm Type
Experimental
Arm Description
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).
Arm Title
mRNA-1608 Dose B
Arm Type
Experimental
Arm Description
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).
Arm Title
mRNA-1608 Dose C
Arm Type
Experimental
Arm Description
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).
Arm Title
BEXSERO
Arm Type
Other
Arm Description
Participants will receive 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57).
Intervention Type
Biological
Intervention Name(s)
mRNA-1608
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
BEXSERO
Intervention Description
A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame
Up to Day 64 (7 days after each injection)
Title
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 85 (28 days after each injection)
Title
Number of Participants with Serious Adverse Events (SAEs)
Time Frame
Day 1 to Day 393 (end of study [EoS])
Title
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame
Day 1 to Day 393 (EoS)
Title
Number of Participants with AEs Leading to Discontinuation From Study
Time Frame
Day 1 to Day 393 (EoS)
Title
Number of Participants with Medically-Attended AEs (MAAEs)
Time Frame
Day 1 through 6 months after last study injection (Day 225)
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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)
Description
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).
Time Frame
Baseline (Day -27 to Day 1), Day 85 to Day 113
Title
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)
Description
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).
Time Frame
Baseline (Day -27 to Day 1), Day 197 to Day 225
Title
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)
Description
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).
Time Frame
Baseline (Day -27 to Day 1), Day 85 to Day 113
Title
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)
Description
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).
Time Frame
Baseline (Day -27 to Day 1), Day 197 to Day 225
Title
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
Title
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
Title
Number of Participants With Vaccine Seroresponse
Description
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.
Time Frame
Baseline (Day 1), Days 85 and 225

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moderna Clinical Trials Support Center
Phone
1-877-777-7187
Email
clinicaltrials@modernatx.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Noble Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedars-Sinai Medical Center/Carbon Health
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Artemis Institute for Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Acclaim Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Multi-Therapeutic Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Suncoast Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Illinois Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Johnson County Clin-Trials (JCCT)
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Individual Site Status
Recruiting
Facility Name
Heartland Research Associates LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Fenway Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Velocity Clinical Research
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Velocity Clinical Research
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of North Carolina (UNC) - Kidney Center (UNCKC)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
M3 Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Velocity Clinical Research, Austin
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Individual Site Status
Recruiting
Facility Name
Helios CR, Inc Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DM Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Texas Center for Drug Development, INC
City
Tomball
State/Province
Texas
ZIP/Postal Code
77064
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Health Research of Hampton Roads
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Washington Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

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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