AIDSVAX B/B Vaccine for HIV-1 Infection Prevention in Adults
This study aims to evaluate the effectiveness of the AIDSVAX B/B Vaccine in preventing HIV-1 infection in adults.
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Blood-Borne Infections+16
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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 MapsPhoenix Body Positive
Phoenix, United StatesArizona Clinical Research Ctr Inc
Tucson, United StatesUniv of California / UCI Med Ctr
Orange, United States