Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes

This study will evaluate the biological effectiveness and safety of the HerpV vaccine in combination with adjuvant QS-21. The Safety and tolerability of HerpV plus QS-21 will also be evaluated by collecting number and severity of adverse events throughout the study.

Participants will undergo a baseline/ screening period. This is a 45 day period when the participant collects a swab of the genital area each day. In case of a recurrence, participant will be required to collect two swabs a day. If the participant collects at least 80% of the swabbing samples and meets all eligibility criteria they may enroll in the study.

Study Period 1 consists of three treatments and a 45 day swabbing period after the last treatment. The participant will collect swabs of the genital region each day for 45 days.

Participants who successfully complete Study Period 1 will proceed to Study Period 2. They will receive a booster injection of study drug or placebo according to their original randomization assignment. The participants will again enter a 45 day swabbing period, collecting swabs of the genital area each day for 45 days.

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.