A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months
rgp120/HIV-1 SF-2
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude de prévention
Résumé
Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest. Ten healthy volunteers receive 200 mcg gp120 in MF59 emulsion, and four volunteers receive placebo consisting of MF59 emulsion in PBS vehicle. Injections are given at months 0, 1, and 6. Patients are followed for 12 months following the third injection.
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.14 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 Subjects must have: Normal history and physical exam. Negative ELISA for HIV. Normal cell-mediated immune responses using Merieux skin test. Normal urinalysis. Exclusion Criteria Co-existing Condition: Subjects with the following conditions are excluded: Evidence of psychological or psychiatric problems that may lead to noncompliance with study requirements. Positive syphilis serology. If serology is documented as a false positive or is due to a remote (> 6 months) treated infection, subject is eligible. Circulating hepatitis B surface antigen. Subjects with the following prior conditions are excluded: History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. History of anaphylaxis or other adverse reactions to vaccines. Prior Medication: Excluded: Prior HIV vaccines. Immunoglobulins or vaccines within the past 3 months. Experimental agents within the past 30 days. Prior Treatment: Excluded: Blood transfusions or cryoprecipitates within the past 3 months. Identifiable high-risk behavior for HIV infection, including: Any history of intravenous (IV) drug use within the past year. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 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 2 sites
Univ of Washington / Pacific Med Ctr
Seattle, United States