Completed

AIDSVAX B/B Vaccine for HIV-1 Infection Prevention in Adults

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Study Aim

This study aims to evaluate the effectiveness of the AIDSVAX B/B Vaccine in preventing HIV-1 infection in adults.

What is being tested

MN rgp120/HIV-1 and GNE8 rgp120/HIV-1

Biological
Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorVaxGen
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorVaxGen
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

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

5000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPathologic ProcessesRetroviridae InfectionsRNA Virus InfectionsSlow Virus DiseasesPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsDisease AttributesAcquired Immunodeficiency SyndromeSexually Transmitted DiseasesHIV Infections

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.)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 67 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

Phoenix Body Positive

Phoenix, United States

Arizona Clinical Research Ctr Inc

Tucson, United States

Univ of California / UCI Med Ctr

Orange, United States
Completed67 Study Centers