A Phase I Trial to Evaluate the HIV-1 SF-2 Recombinant p24 Subunit Vaccine [Chiron Vaccines] Administered as a Novel Boost in "Prime-Boost" Vaccination Regimens With ALVAC-HIV vCP205 [Pasteur Merieux Connaught] and HIV-1 SF-2 rgp120 in MF59 [Chiron Vaccines]
HIV p24/MF59 Vaccine
+ ALVAC-HIV MN120TMG (vCP205)
+ ALVAC-RG Rabies Glycoprotein (vCP65)
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude de prévention
Résumé
There are currently several Phase I and II clinical trials being performed within AVEG to evaluate different HIV-1 vaccine candidates. The HIV-1 vaccination approach that is furthest along the clinical development pathway is the so-called prime-boost regimen of live recombinant canarypox priming (ALVAC-HIV vCP205) with recombinant subunit protein boosting (HIV-1 SF-2 rgp120 in MF59 adjuvant). The protein boost enhances neutralizing antibody responses against laboratory strains of HIV-1 in assays performed in vitro, as well as enhancing CD4 cell response and increasing the frequency of CD8 cytotoxic T lymphocytes (CTLs). In all of the ALVAC-HIV trials of the prime-boost regimen completed to date, the protein boost has been the HIV-1 SF-2 rgp120 subunit protein. This study is designed to explore whether boosting of live recombinant canarypox vaccination with a novel protein subunit, recombinant HIV-1 SF-2 p24, can enhance the CD4 and CD8 cell responses directed against HIV-1 antigens. Volunteers are randomized to 1 of 5 groups. All volunteers receive a total of 4 immunizations, administered at Months 0, 1, 3, and 6. Each group receives a different combination of vaccines as follows: Group 1: ALVAC-HIV vCP205 plus HIV-1 SF-2 p24. Group 2: ALVAC-HIV vCP205 plus MF59 adjuvant and citrate vehicle (control for HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120) at Months 0 and 1; then ALVAC-HIV vCP205 plus HIV-1 SF-2 p24 at months 3 and 6. Group 3: ALVAC-HIV vCP205 plus control at Months 0 and 1; then ALVAC-HIV vCP205 plus HIV-1 SF-2 p24 combined with HIV-1 SF-2 rgp120 at Months 3 and 6. Group 4: ALVAC-HIV vCP205 plus control at Months 0 and 1; then ALVAC-HIV vCP205 plus HIV-1 SF-2 rgp 120 at Months 3 and 6. Group 5: ALVAC-RG vCP65 (control for ALVAC-HIV vCP205) plus control at Months 0,1,3, and 6. The study lasts for approximately 18 months; patients receive clinical evaluations to measure vaccine safety at 11 study visits at specified time intervals.
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.40 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 You may be eligible for this study if you: Are between the ages of 18 and 60. Are HIV-negative. Are negative for Hepatitis B. Have a normal physical exam. Are available for 18 months of follow-up. Agree to use an effective method of birth control for 1 month before receiving a vaccine and during the study. Exclusion Criteria You will not be eligible for this study if you: Have a history of an immunodeficiency, chronic illness, or cancer. Have a medical or psychiatric condition which would make you unable to comply with the study. Are at higher-risk for HIV infection; for example, have a history of injection drug use in the past year or practice higher risk sexual behavior. Have syphilis or tuberculosis. Have received a live vaccine in the past 60 days, have ever received an HIV vaccine or placebo in a previous HIV vaccine study, or have ever received a rabies vaccine. Have a history of a serious allergic reaction to a vaccine or to any other substance, including neomycin or egg products. Have received certain medications. Are pregnant or breast-feeding.
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 7 sites
JHU AVEG
Baltimore, United StatesSt. Louis Univ. School of Medicine AVEG
St Louis, United StatesUniv. of Rochester AVEG
Rochester, United States