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
  Purpose

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.


Condition Intervention Phase
Genital Herpes
Drug: AG-707
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Phase 1 Trial Evaluating Safety, Tolerability and Immune Response of AG-707 Compared to Placebo in HSV-2 Seropositive Patients

Resource links provided by NLM:


Further study details as provided by Agenus, Inc.:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 35
Study Start Date: March 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231049

Locations
United States, Indiana
Indianapolis, Indiana, United States
United States, Oregon
Portland, Oregon, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Agenus, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00231049     History of Changes
Other Study ID Numbers: C-400-01
Study First Received: September 30, 2005
Last Updated: October 24, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Agenus, Inc.:
Genital Herpes
HSV-2 Seropositive
Vaccine

Additional relevant MeSH terms:
Herpes Genitalis
DNA Virus Infections
Genital Diseases, Female
Genital Diseases, Male
Herpes Simplex
Herpesviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014