An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV
- Conditions
- HIV Infections
- Registration Number
- NCT00027365
- Brief Summary
The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines.
There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to prevent HIV disease is the best way to try to deal with this situation. Several vaccine products have been tested, but only 2 are still in trial. There is a need for a new product.
- Detailed Description
Despite recent advances in the treatment and prevention of HIV disease, the epidemic is worsening throughout most of the world. HIV/AIDS is the leading cause of death in sub-Saharan Africa and the leading infectious cause of death in the world. An effective and inexpensive vaccine to prevent HIV disease remains as the best option to try to deal with this expanding epidemic. A number of vaccine products have been tested; however, only 2 have progressed to a Phase III trial, underscoring the need for new vaccine strategies.
Prior to study entry, participants have their risk status for HIV infection determined by a series of questions. Further eligibility is determined by results of physical exam, laboratory tests, and further questions. Blood is drawn on each study visit. Participants are assigned randomly to 1 of 4 study groups:
Group I: NefTat or placebo. Groups II, III, and IV: NefTat and gp120 or placebo. Each group receives a different concentration of gp120.
All immunizations are admixed with AS02A adjuvant. Vaccinations are administered intramuscularly at 3 time points (entry, 1 month, and 3 months). Product safety and immunogenicity are performed at designated time points; participants have about 11 clinic visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Fenway Community Health Clinical Research Site (FCHCRS)
🇺🇸Boston, Massachusetts, United States
HIV Prevention & Treatment CRS
🇺🇸New York, New York, United States
NY Blood Ctr./Bronx CRS
🇺🇸Bronx, New York, United States
Univ. of Rochester HVTN CRS
🇺🇸Rochester, New York, United States
NY Blood Ctr./Union Square CRS
🇺🇸New York, New York, United States
Vanderbilt Vaccine CRS
🇺🇸Nashville, Tennessee, United States
Alabama Vaccine CRS
🇺🇸Birmingham, Alabama, United States
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research, Project SAVE-Baltimore
🇺🇸Baltimore, Maryland, United States
San Francisco Vaccine and Prevention CRS
🇺🇸San Francisco, California, United States
Project Brave HIV Vaccine CRS
🇺🇸Baltimore, Maryland, United States
Miriam Hospital's HVTU
🇺🇸Providence, Rhode Island, United States
Saint Louis Univ. School of Medicine, HVTU
🇺🇸Saint Louis, Missouri, United States
FHCRC/UW Vaccine CRS
🇺🇸Seattle, Washington, United States
Brigham and Women's Hosp. CRS
🇺🇸Boston, Massachusetts, United States
Infectious Diseases Physicians, Inc.
🇺🇸Annandale, Virginia, United States