This is a sequential, dose-escalating study of three dose cohorts of AG-707. Individuals who meet all of the inclusion and exclusion criteria for eligibility will be randomized to receive either AG-707 (at the 100 µg dose), AG-707 with QS-21 (at the 100 µg dose), placebo, or QS-21. Each patient will be monitored for safety as specified in the protocol.

Condition	Intervention	Phase
Genital Herpes HSV-2 Seropositive	Drug: AG-707	Phase I

Further study details as provided by Antigenics:

Primary Outcomes: Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 100, 300 and 500 mg compared to placebo and QS-21 alone in HSV-2 seropositive adults.
Secondary Outcomes: Determine immune response to AG-707 vaccination (with and without QS-21) at dose cohorts of 100, 300, and 500 mg as compared to placebo and QS-21 alone.
Expected Total Enrollment:  84

Primary Objective:

Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 100, 300 and 500 mg compared to placebo and QS-21 alone in HSV-2 seropositive adults.

Secondary Objective:

Determine immune response to AG-707 vaccination (with and without QS-21) at dose cohorts of 100, 300, and 500 mg as compared to placebo and QS-21 alone.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients must be seropositive for HSV-2 (+/- HSV-1) and have a documented history of clinically active genital herpes (at least one prior outbreak).
• Patients must be seronegative for HIV.
• Have baseline chemistry, hematology, PT, PTT within normal limits, and total CPK laboratory values < 1.25X the upper limit of normal (according to the normal reference ranges of the Central Laboratory) at baseline (Screening & Pre-Study Visit) and considered not clinically significant by the investigator.]
• Patients must not be taking antiviral therapy.
• Must be 18 years of age and willing to either use an effective method of contraception or abstain from sexual activity for the 28-week duration of the trial.

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.
• History of HSV infection of the eye (herpes simplex interstitial keratitis or uveitis), or herpes-associated erythema multiforme.
• History of immune suppression or autoimmune disorder.
• Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable.
• Patients with known hypersensitivity or allergies to acyclovir or valacyclovir.

Please refer to this study by ClinicalTrials.gov identifier  NCT00231049

Medical Communications      1-866-805-8994    clinicalaffairs@antigenics.com

Study ID Numbers:  C-400-01
Last Updated:  December 8, 2005
Record first received:  September 30, 2005
ClinicalTrials.gov Identifier:  NCT00231049
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10