Safety of the EnvPro HIV Vaccine in Healthy Volunteers
The purpose of this study is to determine the safety of a new HIV vaccine. The vaccine in this study is mixed with a chemical called alum to improve the body's response to the vaccine. Healthy adults who are not infected with HIV may participate in the study.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluation of Tolerability and Safety of a Recombinant Purified HIV Envelope Vaccine|
|Study Start Date:||August 2003|
EnvPro is a recombinant, purified envelope protein vaccine with an aluminum hydroxide (alum) adjuvant. Aluminum hydroxide is licensed as an adjuvant in other vaccines, such as the hepatitis B vaccine. This study will examine the safety and tolerability of EnvPro with alum adjuvant in healthy, HIV uninfected adults.
All participants in this study will receive vaccine injections in the upper arm muscle. Participants will receive a second vaccine injection eight weeks after the first injection. Blood tests will be performed at study visits before the vaccine is given, during the eight weeks between injections, and at selected times for up to three years after the vaccine is given.
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Karen Slobod, MD|