This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. Objectives: * To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: * Time to first clinical and/or virologic recurrence after Dose 3 (Day 43) * Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine * Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period * Antiviral use. * To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
University of Alabama Vaccine Research Unit
Birmingham, Alabama, United States
Medical Center for Clinical Research
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Illinois Department of Medicine
Chicago, Illinois, United States
Indiana University Infectious Disease Research
Indianapolis, Indiana, United States
The Fenway Institute
Boston, Massachusetts, United States
UNC Global HIV Prevention and Treatment Clinical Trials Unit
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Westover Heights Clinic
Portland, Oregon, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
...and 6 more locations
Impact on clinical HSV-2 disease based on time to recurrence and lesion rate
Time frame: 53 weeks
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 57 weeks
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