Vaccin AIDSVAX B/B pour la prévention de l'infection par le VIH-1 chez les adultes
Cette étude vise à évaluer l'efficacité du vaccin AIDSVAX B/B dans la prévention de l'infection par le VIH-1 chez les adultes.
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Infections transmises par le sang+16
+ Maladies génito-urinaires
+ Maladies Génitales
Étude de prévention
Résumé
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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.5000 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 60 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.)
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 67 sites
Univ of Alabama at Birmingham
Birmingham, United StatesOuvrir Univ of Alabama at Birmingham dans Google MapsPhoenix Body Positive
Phoenix, United StatesArizona Clinical Research Ctr Inc
Tucson, United StatesUniv of California / UCI Med Ctr
Orange, United States