Trial Evaluating Safety, Tolerability and Immune Response of AG-707

This study has been completed.
Sponsor:
Information provided by:
Agenus, Inc.
ClinicalTrials.gov Identifier:
NCT00231049
First received: September 30, 2005
Last updated: October 24, 2008
Last verified: October 2008

September 30, 2005
October 24, 2008
March 2006
Not Provided
Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 80, 240 and 400 µg compared to placebo and QS-21 alone in herpes simplex virus-2 (HSV-2) seropositive adults
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.
Complete list of historical versions of study NCT00231049 on ClinicalTrials.gov Archive Site
Determine immune response to AG-707 vaccination (with and without QS-21) at dose cohorts of 80, 240, and 400 µg as compared to placebo and QS-21 alone
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.
Not Provided
Not Provided
 
Trial Evaluating Safety, Tolerability and Immune Response of AG-707
A Phase 1 Trial Evaluating Safety, Tolerability and Immune Response of AG-707 Compared to Placebo in HSV-2 Seropositive Patients

This is a randomized, multi-center, 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 80 µg dose), AG-707 with QS-21 (at the 80 µg dose), placebo, or QS-21. Each patient will be monitored for safety as specified in the protocol.

Primary Objective:

Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 80, 240 and 400 µg 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 80, 240, and 400 µg as compared to placebo and QS-21 alone.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Genital Herpes
Drug: AG-707
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
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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.
  • Patients must be seronegative for hepatitis B and C
  • Have baseline chemistry and hematology (hemoglobin, white blood cell (WBC), absolute neutrophil count (ANC), eosinophils) within normal limits; prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal (ULN), and platelets above the lower limit of normal (LLN). Basophils, lymphocytes and monocytes must be within 1.2 x ULN or 0.8 x LLN and considered not clinically significant by the investigator. Total creatine phosphokinase (CPK) laboratory values < 1.25X the upper limit of normal (according to the normal reference ranges of the Central Laboratory) at baseline (Screening and Pre-Study Visit) and considered not clinically significant by the Investigator.
  • Patients must not be taking antiviral therapy.
  • Must be between the ages of 18 and 50 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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00231049
C-400-01
Not Provided
Not Provided
Agenus, Inc.
Not Provided
Not Provided
Agenus, Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP