ALVAC-HIV vCP205 et HIV-1 SF-2 rgp120 pour la prévention du VIH-1 chez les adultes non infectés
Cette étude de phase 2 vise à évaluer l'efficacité de l'ALVAC-HIV vCP205 et du HIV-1 SF-2 rgp120 dans la prévention de l'infection au VIH-1 chez les adultes non infectés.
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
+ MN rgp120/HIV-1 and A244 rgp120/HIV-1
+ ALVAC-HIV MN120TMG (vCP205)
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude de prévention
Résumé
In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.] Volunteers are recruited and screened; those who are enrolled are then stratified by their risk status into 2 groups: individuals having lower-risk behavior for HIV and individuals having higher-risk behavior for HIV. Volunteers are then randomly assigned to arm A, B, or C and receive immunizations at months 0, 1, 3, and 6 as follows: Group A- ALVAC vCP205 plus SF-2 rgp120 in MF59. Group B- ALVAC vCP205 plus saline placebo. Group C- Placebo-ALVAC plus saline placebo. [AS PER AMENDMENT 7/2/98: Beginning 12-18 months after initial vaccination, then 2, 6, and 12 months later, 10 volunteers from group A receive saline placebo, while 50 volunteers each from groups B and C are rerandomized within their respective groups, and are treated as follows. Group B (subgroup 1) - AIDSVAX B/B. Group B (subgroup 2) - AIDSVAX B/E. Group B (subgroup 3) - alum placebo. Group C (subgroup 1) - AIDSVAX B/B. Group C (subgroup 2) - AIDSVAX B/E. Group C (subgroup 3) - alum placebo.] Volunteers are followed for 2 years and are tested for humoral immune response to HIV-1. Neutralizing activity to HIV-1 is performed on a subset of volunteers monitored for CTL response. [AS PER AMENDMENT 7/2/98: Volunteers receiving AIDSVAX B/B and AIDSVAX B/E will additionally be studied for formation of various neutralizing antibodies and parameters of cellular immunity.] [AS PER AMENDMENT 4/30/99: Because the subunit boosts that were added in version 3.0 are not available, the subunit boost portion of version 3.0 is cancelled.]
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.420 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
Inclusion Criteria Participants must have: Negative ELISA for HIV within 8 weeks of immunization. Normal history and physical examination. Availability for follow-up for planned duration of at least 24 months and willing to have 2 brief evaluations at 36 and 48 months. Exclusion Criteria Co-existing Condition: Participants with the following symptoms or conditions are excluded: Active syphilis. NOTE: AS PER AMENDMENT 6/25/97: Participant eligible if the serology is documented to be a false positive or due to adequately treated infection. Active tuberculosis (TB). NOTE: Participant eligible if positive purified protein derivative and normal chest x-ray shows no evidence of TB and does not require isoniazid therapy. Participants with the following prior conditions are excluded: History of immunodeficiency, chronic illness, malignancy, idiopathic anaphylaxis (AS PER AMENDMENT 6/25/97) or autoimmune disease. Participants with a history of cancer are excluded unless they have undergone surgery followed by a sufficient observation period to give a reasonable assurance of cure. Any history of anaphylaxis or history of other serious adverse reactions to vaccines. Immediate-type hypersensitivity reaction to egg products or neomycin (used to prepare ALVAC vaccines). Prior Medication: Excluded: Immunosuppressive medications. Live attenuated vaccines within 60 days of study. Use of investigational agents within 30 days prior to study. Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial. Prior Treatment: Excluded: Receipt of blood products or immunoglobulin within past 6 months. Risk Behavior: Excluded: Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol. Specifically excluded are persons with a history of suicide attempts within 3 years, recent suicidal ideation or who have past or present psychosis. Medically indicated subunit or killed vaccines, e.g., influenza, pneumococcal, hepatitis A and B allowed provided administered more than 2 weeks from HIV study immunizations.
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 18 sites
Public Health Enterprises Foundation, Inc. HIVNET
San Francisco, United StatesDenver Dept. of Health HIVNET
Denver, United StatesDenver Public Health CRS
Denver, United States