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

Completed · Phase 2 · Has a placebo group

Conditions studied: Herpes Simplex Type 2

In brief

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.

Key facts

Study ID

NCT01687595

Run by

Agenus Inc.

People needed

80

Starts

2012-10-29

Expected to finish

2015-01-01

Last updated by the study team

2021-07-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Westover Heights Clinic — Portland, Oregon, United States
• Center for Clinical Studies - Texas Medical Center — Houston, Texas, United States
• Center for Clinical Studies - Cypress — Houston, Texas, United States
• Center for Clinical Studies- Webster — Houston, Texas, United States
• University of Washington Virology Research Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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