Sécurité et immunogénicité du vaccin Chiron HIV p24/MF59 chez les adultes en bonne santé
HIV p24/MF59 Vaccine
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude de prévention
Résumé
This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at 0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. If no serious adverse events are observed within 1 week after the first injection in these first 15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to receive HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5 volunteers receive the placebo.
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 50 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 Volunteers must have: Good health as determined by medical history, physical examination, and clinical judgment. Negative serology for HIV infection as determined by licensed HIV ELISA test performed within 6 weeks prior to first immunization. In vitro Epstein-Barr virus-immortalized cell line from peripheral blood can be established (required for selected Part B volunteers only). Exclusion Criteria Co-existing Condition: Volunteers with the following symptoms or conditions are excluded: Significant acute systemic infection. Occupational or other responsibilities that would prevent completion of participation in the study. Any condition that might interfere with the evaluation of the study objectives. Volunteers with the following prior conditions are excluded: History of immunodeficiency, autoimmune disease, or any serious chronic illness. Evidence of psychiatric or medical history or substance abuse that would adversely affect the volunteer's ability to participate in the trial. History of anaphylaxis or other serious adverse reactions to vaccines or vaccine components. 1. Immunosuppressive medications. Live, attenuated vaccine within 60 days of study entry. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza or pneumococcal) are not exclusionary but should be given at least 4 weeks before or after HIV immunizations to avoid potential confusion of adverse reactions. Experimental agents within 30 days of study entry. HIV vaccine or MF59 adjuvant. Blood products or immunoglobulins in the past 3 months. Engaging in high-risk behavior within 6 months of study entry, i.e.: injection drug use, sexual intercourse without a condom with 4 or more partners or with known iv drug user or HIV+ partner, or newly acquired sexually-transmitted disease.
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 1 site
Creighton Univ Med Ctr / Ped Infect Disease Div
Omaha, United StatesOuvrir Creighton Univ Med Ctr / Ped Infect Disease Div dans Google Maps