A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
gp160 Vaccine (MicroGeneSys)
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude de prévention
Résumé
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest. Healthy volunteers are injected on days 0, 30, 180, and 365 with either 160 mcg gp160 vaccine (20 volunteers) or an alum placebo preparation (10 volunteers).
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.30 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 Subjects must have: Normal history and physical exam. Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24). T4 count >= 800 cells/mm3. Normal chest x-ray and urinalysis. Negative hepatitis B surface antigen. Negative HIV p24 antigen test. Normal skin reactivity by Merieux test. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: Positive PPD. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease). Subjects with the following prior conditions are excluded: History of immunodeficiency, chronic illness, or use of immunosuppressive medications. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. Prior Treatment: Excluded: Prior blood transfusions or cryoprecipitates within the past 6 months. Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including: Any history of IV drug use. 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 1 site
St. Louis Univ. School of Medicine AVEG
St Louis, United StatesOuvrir St. Louis Univ. School of Medicine AVEG dans Google Maps