Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
Herpes Simplex Type 2
About this trial
This is an interventional treatment trial for Herpes Simplex Type 2 focused on measuring herpes simplex virus type 2,, genital herpes
Eligibility Criteria
Inclusion Criteria:
- Seropositive for herpes simplex virus type 2 (HSV-2)
- Clinically active genital herpes defined as a history of 1-9 episodes per year for at least 1 year prior to screening or 1 year prior to beginning suppressive therapy.
- Willing to either use an effective method of contraception or abstain from sexual intercourse throughout the 48-week study period.
- If female of childbearing potential, have a negative serum pregnancy test.
- Agree to not receive any other investigational drugs while enrolled in this study.
- The above criteria must be met before participants are allowed to enter the 45-day swabbing period to be screen for the study.
- Completion and collection of greater than or equal to 80% (36 days) of the 45-day consecutive daily genital swabs.
Exclusion Criteria:
- Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion.
- A history of herpes simplex virus (HSV) infection of the eye (herpes simplex interstitial keratitis or uveitis), or herpes-associated erythema multiforme.
- A history of immune suppression or autoimmune disorder.
- Continued use of suppressive anti-viral therapy for HSV-2; a 1 week washout of any anti-viral therapy (suppressive and episodic) is required prior to initiating the swabbing period.
- Concomitant use of systemic corticosteroids or immune-suppressive medications. The use of nasal steroids is acceptable.
- Human immunodeficiency virus (HIV) positive.
- Presence of active Hepatitis B or C infection.
- Known hypersensitivity or allergies to acyclovir or valacyclovir.
- Pregnant or breast-feeding women.
Sites / Locations
- Westover Heights Clinic
- Center for Clinical Studies - Texas Medical Center
- Center for Clinical Studies - Cypress
- Center for Clinical Studies- Webster
- University of Washington Virology Research Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
HerpV 240 μg + QS-21 50 μg
Placebo
Participants will receive a combination of HerpV 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 will receive a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period will be followed by a washout period of 1 week.
Participants will receive a placebo injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period will be followed by a washout period of 1 week.