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

Genital Herpes Clinical Trial

Official title:
A Phase 1 Trial Evaluating Safety, Tolerability and Immune Response of AG-707 Compared to Placebo in HSV-2 Seropositive Patients

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00231049
Study type Interventional
Source Agenus, Inc.
Contact
Status Completed
Phase Phase 1
Start date March 2006
View Details
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