Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231049
Status:
COMPLETED
Last Update Posted:
2008-10-27
First Post:
2005-09-30
Brief Title:
Trial Evaluating Safety Tolerability and Immune Response of AG-707
Sponsor:
Agenus Inc
Organization:
Agenus Inc
Study Overview
Official Title:
A Phase 1 Trial Evaluating Safety Tolerability and Immune Response of AG-707 Compared to Placebo in HSV-2 Seropositive Patients
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None