A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
Attenuvax
+ M-M-R-II
Complejo Relacionado con el SIDA+14
+ Enfermedades Transmisibles
+ Enfermedades Urogenitales
Estudio de Tratamiento
Resumen
Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system. Patients, HIV infected and uninfected, are randomized to one of two attenuated measles vaccine schedules: at 6 and 12 months of age, or at 12 months of age only. Attenuvax is administered as the month 6 vaccine and M-M-R II as the month 12 vaccine. Patients are followed for 24 months after the last vaccination.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 270 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
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.Entre 6 y 7 meses
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 have: * Willing to have and receive results of HIV test * Been born to mothers with HIV infection or history of AIDS-defining condition by CDC criteria. * No history of opportunistic infection. * No known exposure to measles within 14 days prior to study entry. * CD4+ lymphocyte count \>= 750 cells/mm3 or more than 15% at 6 months of age. * Parent or legal guardian available to give written informed consent and be willing to comply with all study requirements. * Childhood immunizations (other than measles) according to current recommendations of the Immunization Practice Advisory Committee and American Academy of Pediatrics. NOTE: * Coenrollment on other therapeutic protocols (except for ACTG 185) is permitted. NOTE: * Patients must be located in a geographical area where measles immunization at 12 months is standard of care. Recommended: * Childhood immunizations other than measles according to current guidelines. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Intercurrent illness and/or fever for 7 days. * Known sensitivity or allergy to neomycin or eggs. Concurrent Medication: Excluded: * IVIG. * Uninterrupted or anticipated steroid therapy (\>= 2 mg/kg/day) for more than 2 weeks duration. Patients with the prior condition are excluded: * Platelet count \< 50,000/mm3 at any time prior to study entry. Prior Medication: Excluded: * Any IgG preparation within the past 6 months.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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 46 ubicaciones
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, United StatesAbrir UAB, Dept. of Ped., Div. of Infectious Diseases en Google MapsLong Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, United StatesUsc La Nichd Crs
Los Angeles, United StatesUCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, United States