Clinical trial NCT06033261: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Genital Herpes
Keywords: HSV-2
Herpes Simplex Virus Type 2
HSV-2 vaccine
Genital Herpes
mRNA-1608
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
timeFrame: Up to Day 64 (7 days after each injection)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 85 (28 days after each injection)
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Day 1 to Day 393 (end of study [EoS])
measure: Number of Participants with Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 to Day 393 (EoS)
measure: Number of Participants with AEs Leading to Discontinuation From Study
timeFrame: Day 1 to Day 393 (EoS)
measure: Number of Participants with Medically-Attended AEs (MAAEs)
timeFrame: Day 1 through 6 months after last study injection (Day 225)
Secondary outcomes:
measure: Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection
timeFrame: Day 71 to Day 225
measure: Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection
timeFrame: Day 71 to Day 393
measure: 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)
timeFrame: Baseline (Day -27 to Day 1), Day 85 to Day 113
measure: 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)
timeFrame: Baseline (Day -27 to Day 1), Day 197 to Day 225
measure: 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)
timeFrame: Baseline (Day -27 to Day 1), Day 85 to Day 113
measure: 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)
timeFrame: Baseline (Day -27 to Day 1), Day 197 to Day 225
measure: Geometric Mean Titer (GMT) of mRNA-1608 Antigen-Specific Binding Antibodies (bAbs) at 1 and 6 Months After the Second Study Injection
timeFrame: Days 85 and 225
measure: Geometric Mean Fold Rise (GMFR) of mRNA-1608 Antigen-Specific bAbs From Baseline to 1 and 6 Months After the Second Study Injection
timeFrame: Baseline (Day 1), Days 85 and 225
measure: Number of Participants With Vaccine Seroresponse
timeFrame: Baseline (Day 1), Days 85 and 225
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Clinical Sites Network - Cahaba Medical Care
state: Alabama
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Beverly Hills
country: United States
facility: Cedars-Sinai Medical Center/Carbon Health
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Lenexa
country: United States
facility: Johnson County Clin-Trials (JCCT)
state: Kansas
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: New Orleans
country: United States
facility: Research Works
state: Louisiana
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
city: Southfield
country: United States
facility: DM Clinical Research
state: Michigan
city: Grand Island
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Beachwood
country: United States
facility: Velocity Clinical Research Cleveland
state: Ohio
city: Cedar Park
country: United States
facility: Velocity Clinical Research, Austin
state: Texas
city: Fort Worth
country: United States
facility: Helios CR, Inc Fort Worth
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads
state: Virginia
city: Seattle
country: United States
facility: University of Washington Virology Research Clinic
state: Washington
Study officials:
References: