CClinicalTrials.gg
CompletedNCT00002441Updated Jun 24, 2005

Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection

A Phase 3 interventional study of MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 in HIV Infections and HIV Seronegativity, sponsored by VaxGen. Completed at 67 sites in 4 countries. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by VaxGen · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
5,000
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections
  • HIV Seronegativity

Keywords

  • HIV-1
  • Dose-Response Relationship, Drug
  • Acquired Immunodeficiency Syndrome
  • AIDS Vaccines
  • Sexually Transmitted Diseases
  • Risk Factors
  • HIV Seronegativity
  • Antigens, Viral
  • Alum Compounds
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 5,000 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

VaxGen is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Exclusion Criteria

You will not be eligible for this study if you:

  • Use injection drugs.
  • Have a history of any serious diseases or conditions, including lymphoma.
  • Have ever received an HIV vaccine.
  • Have taken post-exposure treatment to prevent HIV infection within 4 weeks prior to study entry.
  • Are planning to take other HIV vaccines during this study.
  • Are pregnant.
  • Have taken certain medications or received certain therapies, including chemotherapy and radiation.
  • Have received certain vaccines within 2-4 weeks prior to study entry.

You may be eligible for this study if you:

  • Are HIV-negative.
  • Are between 18 and 60 years old.
  • Are available for 3 years of follow-up.
  • Agree to use effective methods of birth control during the study and for 90 days after.
  • Are one of the following:
  • A woman who is currently in a sexual relationship with an HIV-positive man.
  • A woman who has had more than one male partner and at least one sexually transmitted disease (STD) within the past 12 months.
  • A man who has sex with men and has had anal intercourse within the past 12 months. (You will not be eligible if you have been in the same relationship with only one HIV-negative man for at least 12 months.)
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Masking
Double
Enrollment
5,000 participants

Interventions

  • BiologicalMN rgp120/HIV-1 and GNE8 rgp120/HIV-1
06

Study locations

67 sites
  • Univ of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • Phoenix Body Positive
    Phoenix, Arizona 85016, United States
  • Arizona Clinical Research Ctr Inc
    Tucson, Arizona 85712, United States
  • Univ of California / UCI Med Ctr
    Orange, California 92868, United States
  • ViRx Inc
    Palm Springs, California 92262, United States
  • Univ of California - Davis Med Ctr / CARES
    Sacramento, California 95817, United States
  • San Francisco Dept of Hlth / AIDS Office
    San Francisco, California 94102, United States
  • San Francisco Gen Hosp
    San Francisco, California 941102859, United States
  • UCSF - San Francisco Gen Hosp
    San Francisco, California 94110, United States
  • Santa Clara Public Health Dept
    San Jose, California 95128, United States
  • AIDS Research Alliance
    West Hollywood, California 90069, United States
  • Denver Hlth and Hosp Authority / Dept of Pub Hlth
    Denver, Colorado 80204, United States
  • Johns Hopkins Univ / Ctr for Immun Rsch
    Washington, District of Columbia 20003, United States
  • IDC Research Initiative
    Altamonte Springs, Florida 32701, United States
  • Community AIDS Resource Inc
    Coral Gables, Florida 33146, United States
  • Community AIDS Resource Inc
    Fort Lauderdale, Florida 33308, United States
  • Boulevard Comprehensive Care Ctr
    Jacksonville, Florida 32209, United States
  • Community AIDS Resource Inc
    Riviera Beach, Florida 33404, United States
  • Infectious Disease Research Institute
    Tampa, Florida 33614, United States
  • Palm Beach Research Ctr
    West Palm Beach, Florida 33409, United States
  • AIDS Research Consortium of Atlanta
    Atlanta, Georgia 30308, United States
  • Univ of Hawaii
    Honolulu, Hawaii 96816, United States
  • Chicago Ctr for Clinical Research
    Chicago, Illinois 60610, United States
  • Univ of Illinois at Chicago / Dept of Medicine
    Chicago, Illinois 60612, United States
  • Howard Brown Health Ctr
    Chicago, Illinois 60613, United States
  • Community Hosp Indianapolis
    Indianapolis, Indiana 46219, United States
  • Louisiana State Univ Med Ctr / Infect Diseases
    New Orleans, Louisiana 70112, United States
  • Fenway Community Health Ctr
    Boston, Massachusetts 02115, United States
  • Abbott Northwestern Hosp
    Minneapolis, Minnesota 55407, United States
  • Hennepin County Med Ctr
    Minneapolis, Minnesota 55415, United States
  • Park Nicollet Med Ctr / Hlth Education
    St. Louis Park, Minnesota 55416, United States
  • St Paul Public Health
    St. Paul, Minnesota 55101, United States
  • Kansas City AIDS Research Consortium
    Kansas City, Missouri 64111, United States
  • Saint Louis Univ Hosp / Ctr for Vacc Dev
    Saint Louis, Missouri 63104, United States
  • Wellness Ctr / Las Vegas
    Las Vegas, Nevada 89102, United States
  • New Jersey Community Research Initiative
    Newark, New Jersey 07103, United States
  • Univ of New Mexico Hlth Sciences Ctr / Dept of Med
    Albuquerque, New Mexico 87131, United States
  • Albany Med College / Div of HIV Medicine
    Albany, New York 12208, United States
  • New York Blood Ctr
    Bronx, New York 10456, United States
  • Project Achieve - New York Blood Ctr - Women only
    Bronx, New York 10456, United States
  • AIDS Services Erie County Med Ctr
    Buffalo, New York 14215, United States
  • St Luke Roosevelt Hosp
    New York, New York 10011, United States
  • New York Univ Med Ctr / Dept of Environmental Med
    New York, New York 10016, United States
  • Mount Sinai Med Ctr / Jack Martin Fund Clinic
    New York, New York 10029, United States
  • Dutchess County Dept of Health
    Poughkeepsie, New York 12601, United States
  • Univ of Rochester Med Ctr
    Rochester, New York 14642, United States
  • Nalle Clinic / Clinical Research Dept
    Charlotte, North Carolina 28207, United States
  • PW Clinical Research / LLC
    Winston Salem, North Carolina 27103, United States
  • Case Western Reserve Univ
    Cleveland, Ohio 44106, United States
  • Ohio State Univ / ACTU-Univ Clinic
    Columbus, Ohio 43210, United States
  • Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg
    Tulsa, Oklahoma 74104, United States
  • Research and Education Group
    Portland, Oregon 97210, United States
  • Philadelphia FIGHT
    Philadelphia, Pennsylvania 19017, United States
  • Univ of Pittsburgh Med School
    Pittsburgh, Pennsylvania, United States
  • Mem Hosp of Rhode Island
    Pawtucket, Rhode Island 02860, United States
  • Miriam Hosp
    Providence, Rhode Island 02906, United States
  • Omega Med Research
    Providence, Rhode Island 02907, United States
  • Nelson Tebedo Health Resource Ctr
    Dallas, Texas 75219, United States
  • Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch
    Dallas, Texas 75219, United States
  • Univ of Texas Med Branch Ctr for Clinical Studies
    Galveston, Texas 77555, United States
  • UTMB Ctr for Clinical Studies / St John Prof Bldg
    Houston, Texas 77058, United States
  • Univ of Washington
    Seattle, Washington 98104, United States
  • Wisconsin AIDS Research Consortium
    Milwaukee, Wisconsin 53203, United States
  • St Pauls Hosp
    Vancouver, British Columbia, Canada
  • Ctr Hosp de Universite de Montreal (CHUM)
    Montreal, Quebec, Canada
  • Municipal Health Service
    Amsterdam, Netherlands
  • Clinical Research of Puerto Rico Inc
    San Juan, 00909, Puerto Rico
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002441
Lead sponsor
VaxGen
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2000. You cannot join it, but the record below documents what was studied.

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