Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
- Conditions
- HIV InfectionsHIV Seronegativity
- Registration Number
- NCT00002441
- Lead Sponsor
- VaxGen
- Brief Summary
The purpose of this study is to see if an HIV vaccine, AIDSVAX B/B, can protect adults who are at risk from becoming infected with HIV. Patients who become infected despite immunization will be studied to see if receiving the vaccine before becoming infected will help keep HIV levels (viral load) low.
- Detailed Description
Volunteers receive 7 blinded, intramuscular vaccinations (at Months 0, 1, 6, 12, 18, 24, 30) containing either the AIDSVAX B/B vaccine or a placebo (aluminum adjuvant only). Volunteers are randomized in a 2 to 1 vaccine-to-placebo ratio. HIV-uninfected persons are followed for a total of 16 visits beginning at screening and continuing until Month 36. Patients who become HIV infected during study are followed every 4 months for at least 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5000
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 (65)
Chicago Ctr for Clinical Research
🇺🇸Chicago, Illinois, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Ohio State Univ / ACTU-Univ Clinic
🇺🇸Columbus, Ohio, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Pittsburgh Med School
🇺🇸Pittsburgh, Pennsylvania, United States
Clinical Research of Puerto Rico Inc
🇵🇷San Juan, Puerto Rico
Univ of California / UCI Med Ctr
🇺🇸Orange, California, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Denver Hlth and Hosp Authority / Dept of Pub Hlth
🇺🇸Denver, Colorado, United States
Community AIDS Resource Inc
🇺🇸Riviera Beach, Florida, United States
PW Clinical Research / LLC
🇺🇸Winston Salem, North Carolina, United States
Arizona Clinical Research Ctr Inc
🇺🇸Tucson, Arizona, United States
Univ of Illinois at Chicago / Dept of Medicine
🇺🇸Chicago, Illinois, United States
Santa Clara Public Health Dept
🇺🇸San Jose, California, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Ctr Hosp de Universite de Montreal (CHUM)
🇨🇦Montreal, Quebec, Canada
New York Blood Ctr
🇺🇸Bronx, New York, United States
Univ of California - Davis Med Ctr / CARES
🇺🇸Sacramento, California, United States
Boulevard Comprehensive Care Ctr
🇺🇸Jacksonville, Florida, United States
St Luke Roosevelt Hosp
🇺🇸New York, New York, United States
Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch
🇺🇸Dallas, Texas, United States
Dutchess County Dept of Health
🇺🇸Poughkeepsie, New York, United States
Nalle Clinic / Clinical Research Dept
🇺🇸Charlotte, North Carolina, United States
Research and Education Group
🇺🇸Portland, Oregon, United States
Omega Med Research
🇺🇸Providence, Rhode Island, United States
Mem Hosp of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States
Municipal Health Service
🇳🇱Amsterdam, Netherlands
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
San Francisco Dept of Hlth / AIDS Office
🇺🇸San Francisco, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Community Hosp Indianapolis
🇺🇸Indianapolis, Indiana, United States
Abbott Northwestern Hosp
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Med Ctr
🇺🇸Minneapolis, Minnesota, United States
UTMB Ctr for Clinical Studies / St John Prof Bldg
🇺🇸Houston, Texas, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
New York Univ Med Ctr / Dept of Environmental Med
🇺🇸New York, New York, United States
Mount Sinai Med Ctr / Jack Martin Fund Clinic
🇺🇸New York, New York, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
St Paul Public Health
🇺🇸St. Paul, Minnesota, United States
ViRx Inc
🇺🇸Palm Springs, California, United States
Kansas City AIDS Research Consortium
🇺🇸Kansas City, Missouri, United States
Fenway Community Health Ctr
🇺🇸Boston, Massachusetts, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Louisiana State Univ Med Ctr / Infect Diseases
🇺🇸New Orleans, Louisiana, United States
Infectious Disease Research Institute
🇺🇸Tampa, Florida, United States
Wellness Ctr / Las Vegas
🇺🇸Las Vegas, Nevada, United States
AIDS Services Erie County Med Ctr
🇺🇸Buffalo, New York, United States
Miriam Hosp
🇺🇸Providence, Rhode Island, United States
New Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Project Achieve - New York Blood Ctr - Women only
🇺🇸Bronx, New York, United States
Nelson Tebedo Health Resource Ctr
🇺🇸Dallas, Texas, United States
Johns Hopkins Univ / Ctr for Immun Rsch
🇺🇸Washington, District of Columbia, United States
AIDS Research Alliance
🇺🇸West Hollywood, California, United States
Palm Beach Research Ctr
🇺🇸West Palm Beach, Florida, United States
Howard Brown Health Ctr
🇺🇸Chicago, Illinois, United States
Park Nicollet Med Ctr / Hlth Education
🇺🇸St. Louis Park, Minnesota, United States
Albany Med College / Div of HIV Medicine
🇺🇸Albany, New York, United States
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
🇺🇸Albuquerque, New Mexico, United States
Saint Louis Univ Hosp / Ctr for Vacc Dev
🇺🇸Saint Louis, Missouri, United States
Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg
🇺🇸Tulsa, Oklahoma, United States
Univ of Texas Med Branch Ctr for Clinical Studies
🇺🇸Galveston, Texas, United States
St Pauls Hosp
🇨🇦Vancouver, British Columbia, Canada
Wisconsin AIDS Research Consortium
🇺🇸Milwaukee, Wisconsin, United States