Phase
Condition
Herpes Simplex Infections
Genital Herpes
Treatment
BEXSERO
mRNA-1608
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has a diagnosis of genital HSV-2 infection for at least 1 year beforethe 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 nomore than 9 reported genital herpes recurrences in the 12 months preceding theScreening Visit, or if currently on suppressive therapy, prior to initiation ofsuppressive therapy.
Willing to refrain from taking suppressive antiviral therapy from the ScreeningVisit 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, adequatecontraception, and not currently breastfeeding.
Exclusion
Exclusion Criteria:
Prior immunization with a vaccine containing HSV antigens.
History of any form of ocular HSV infection, HSV-related erythema multiforme, orHSV-related neurological complications.
History of genital HSV-1 infection.
History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) types 1or 2 (HIV-1, HIV-2).
Reported history of anaphylaxis or severe hypersensitivity reaction after receipt ofany mRNA vaccine(s) or any components of the mRNA vaccines.
Previously received BEXSERO or other vaccine to prevent serogroup B meningococcaldisease (also known as meningitis B).
History of allergic disease or reactions likely to be exacerbated by any componentof BEXSERO vaccine.
Has received or plans to receive any licensed or authorized vaccine, includingCOVID-19 vaccines, ≤ 28 days prior to the first study injection (Day 1), or plans toreceive a licensed or authorized vaccine within 28 days before or after studyinjection with the exception of licensed influenza vaccines, which may be receivedmore than 14 days before or after any study injection.
Note: Other inclusion and exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Accel Clinical Sites Network - Cahaba Medical Care
Birmingham, Alabama 35218
United StatesSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35205
United StatesSite Not Available
Noble Clinical Research
Tucson, Arizona 85704
United StatesSite Not Available
Cedars-Sinai Medical Center/Carbon Health
Beverly Hills, California 90211
United StatesSite Not Available
Artemis Institute for Clinical Research
Riverside, California 92503
United StatesSite Not Available
Acclaim Clinical Research
San Diego, California 92120
United StatesSite Not Available
Multi-Specialty Research Associates, Inc.
Lake City, Florida 32055
United StatesSite Not Available
Multi-Therapeutic Research Associates, Inc.
Lake City, Florida 32055
United StatesSite Not Available
Suncoast Research Associates, LLC
Miami, Florida 33173
United StatesSite Not Available
University of Illinois Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas 66219
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Newton, Kansas 67114
United StatesSite Not Available
Heartland Research Associates LLC
Newton, Kansas 67114
United StatesSite Not Available
Research Works
New Orleans, Louisiana 70125
United StatesSite Not Available
Fenway Health
Boston, Massachusetts 02215
United StatesSite Not Available
DM Clinical Research
Southfield, Michigan 48076
United StatesSite Not Available
Alliance for Multispecialty Research
Kansas City, Missouri 64114
United StatesSite Not Available
The Center for Pharmaceutical Research
Kansas City, Missouri 64114
United StatesSite Not Available
Velocity Clinical Research
Grand Island, Nebraska 68803
United StatesSite Not Available
Velocity Clinical Research
Norfolk, Nebraska 68701
United StatesSite Not Available
Rochester Clinical Research
Rochester, New York 14609
United StatesSite Not Available
UNC Institute for Global Health and Infectious Diseases
Chapel Hill, North Carolina 27599
United StatesSite Not Available
University of North Carolina (UNC) - Kidney Center (UNCKC)
Chapel Hill, North Carolina 27599
United StatesSite Not Available
M3 Wake Research, Inc.
Raleigh, North Carolina 27612
United StatesSite Not Available
Velocity Clinical Research Cleveland
Beachwood, Ohio 44122
United StatesSite Not Available
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Velocity Clinical Research, Austin
Cedar Park, Texas 78613
United StatesSite Not Available
Helios CR, Inc Fort Worth
Fort Worth, Texas 76107
United StatesSite Not Available
DM Clinical Research
Houston, Texas 77081
United StatesSite Not Available
Sun Research Institute
San Antonio, Texas 78215
United StatesSite Not Available
DM Clinical Research
Tomball, Texas 77064
United StatesSite Not Available
Texas Center for Drug Development, INC
Tomball, Texas 77064
United StatesSite Not Available
Health Research of Hampton Roads
Newport News, Virginia 23606
United StatesSite Not Available
University of Washington Virology Research Clinic
Seattle, Washington 98104
United StatesSite Not Available
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