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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of recombinant human heat shock protein 70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital herpes by evaluating viral shedding before and after treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agenus Inc.
• Treatments: QS 21

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.