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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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Active, not recruiting |
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