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

June 23, 2005 updated by: VaxGen

A Phase III Trial to Determine the Efficacy of Bivalent AIDSVAX B/B Vaccine in Adults at Risk of Sexually Transmitted HIV-1 Infection in North America

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VaxGen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 1999

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VAX 004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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