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

ModernaTX, Inc.365 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

365

Conditions

Genital Herpes

Interventions

mRNA-1608BIOLOGICAL

Sterile liquid for injection

BEXSEROBIOLOGICAL

A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (23)

Accel Clinical Sites Network - Cahaba Medical Care

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

Time frame: Up to Day 64 (7 days after each injection)

Number of Participants with Unsolicited Adverse Events (AEs)

Time frame: Up to Day 85 (28 days after each injection)

Number of Participants with Serious Adverse Events (SAEs)

Time frame: 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)

Number of Participants with AEs Leading to Discontinuation From Study

Time frame: 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)

Secondary Outcomes

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

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

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).

Data from ClinicalTrials.gov

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