Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Antigenics |
---|---|
Information provided by: | Antigenics |
ClinicalTrials.gov Identifier: | NCT00231049 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 Trial Evaluating Safety, Tolerability and Immune Response of AG-707 Compared to Placebo in HSV-2 Seropositive Patients |
Enrollment: | 35 |
Study Start Date: | March 2006 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
Study ID Numbers: | C-400-01 |
Study First Received: | September 30, 2005 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00231049 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Genital Herpes HSV-2 Seropositive Vaccine |
Genital Diseases, Female Virus Diseases Herpes Simplex Sexually Transmitted Diseases, Viral Herpes Genitalis |
Sexually Transmitted Diseases DNA Virus Infections Genital Diseases, Male Herpesviridae Infections |
Genital Diseases, Female Virus Diseases Herpes Simplex Sexually Transmitted Diseases, Viral Herpes Genitalis |
Sexually Transmitted Diseases DNA Virus Infections Genital Diseases, Male Herpesviridae Infections |