A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-mcg Dose
gp160 Vaccine (Immuno-AG)
Infecciones Transmitidas por la Sangre+13
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Prevención
Resumen
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV. Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are randomly assigned to receive three injections of either 200 mcg gp160 vaccine or a placebo. At each participating site, four volunteers receive vaccine and two volunteers receive placebo. Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting. Volunteers are closely monitored for the first 2 weeks postimmunization (primary and boosters), and extensively followed for 2 years. Volunteers may be offered an additional booster of the same preparation at 12 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 25 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 60 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria Patients must be: Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study. Available for 2 years of follow-up. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: History of positive PPD (tuberculin test) and abnormal chest x-ray. Positive syphilis serology (e.g., RPR). Positive for circulating hepatitis B surface antigen. Patients with the following are excluded: They or their sexual partners have identifiable high-risk behavior for HIV infection. History of immunodeficiency or chronic illness. Evidence of psychological or psychiatric problems that may lead to noncompliance. Prior Medication: Excluded: Immunosuppressive medications. Prior Treatment: Excluded: Blood transfusions or cryoprecipitates within the past 6 months.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 3 ubicaciones
St. Louis Univ. School of Medicine AVEG
St Louis, United StatesAbrir St. Louis Univ. School of Medicine AVEG en Google MapsUniv. of Rochester AVEG
Rochester, United StatesVanderbilt Univ. Hosp. AVEG
Nashville, United States