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COMPLETED
NCT06033261
PHASE1/PHASE2

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

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

303

Start Date

2023-09-06

Completion Date

2025-04-25

Last Updated

2026-05-08

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

mRNA-1608

Sterile liquid for injection

BIOLOGICAL

BEXSERO

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

Locations (23)

Accel Clinical Sites Network - Cahaba Medical Care

Birmingham, Alabama, United States

Noble Clinical Research

Tucson, Arizona, United States

Cedars-Sinai Medical Center/Carbon Health

Beverly Hills, California, United States

Acclaim Clinical Research

San Diego, California, United States

Multi-Specialty Research Associates, Inc.

Lake City, Florida, United States

Suncoast Research Associates, LLC

Miami, Florida, United States

Johnson County Clin-Trials (JCCT)

Lenexa, Kansas, United States

Alliance for Multispecialty Research, LLC

Newton, Kansas, United States

Research Works

New Orleans, Louisiana, United States

Fenway Health

Boston, Massachusetts, United States

DM Clinical Research

Southfield, Michigan, United States

Velocity Clinical Research

Grand Island, Nebraska, United States

Velocity Clinical Research

Norfolk, Nebraska, United States

Rochester Clinical Research

Rochester, New York, United States

M3 Wake Research, Inc.

Raleigh, North Carolina, United States

Velocity Clinical Research Cleveland

Beachwood, Ohio, United States

Velocity Clinical Research, Austin

Cedar Park, Texas, United States

Helios CR, Inc Fort Worth

Fort Worth, Texas, United States

DM Clinical Research

Houston, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Health Research of Hampton Roads

Newport News, Virginia, United States

University of Washington Virology Research Clinic

Seattle, Washington, United States