Study Evaluating Vaccine in Adults With HIV
The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV.
A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.
Biological: HIV CTL MEP 1000 micrograms, 19 months per subject
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.|
- To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.
- To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
|Study Start Date:||December 2004|
|Study Completion Date:||February 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195234
|United States, California|
|Sacramento, California, United States, 95817|
|United States, Colorado|
|Denver, Colorado, United States, 80262|
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|New York, New York, United States, 10003|
|United States, Ohio|
|Cleveland, Ohio, United States, 44106-5083|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232-2582|
|United States, Texas|
|Austin, Texas, United States, 78705|
|Dallas, Texas, United States, 75246|
|Dallas, Texas, United States, 75390-9103|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|