A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
Pneumococcal Vaccine, Polyvalent (23-valent)
+ Pneumococcal Conjugate Vaccine, Heptavalent
+ Placebo
Complejo Relacionado con el SIDA+17
+ Enfermedades Transmisibles
+ Enfermedades Urogenitales
Estudio de Prevención
Resumen
Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein. Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age. Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months of age.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 60 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.Entre 2 y 6 meses
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria Concurrent Medication: Allowed: * Antipyretics for rectal temperature \>= 100.4 F. * Antiretroviral therapy. Patients must have: * HIV positivity. * Birth weight at least 1800 g (3.75 lb). * Consent and compliance of parent or guardian. NOTE: * Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Enrollment in HIV vaccine trials. * Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures. * Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia. * Hypogammaglobulinemia. Concurrent Medication: Excluded: * Prophylactic antipyretics. Patients with the following prior conditions are excluded: Acute moderate to severe intercurrent illness or fever within 72 hours prior to study entry. Prior Medication: Excluded: * Any prior pneumococcal vaccine. * Measles vaccine within 1 month prior to study vaccination. * Any other routine vaccine within 1 week prior to study vaccination. * Any immunosuppressant agent, including prednisone, for more than 6 weeks. Prior Treatment: Excluded: * Blood products within 56 days prior to study vaccination.
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
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos 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 33 ubicaciones
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, United StatesUCSD Maternal, Child, and Adolescent HIV CRS
San Diego, United StatesSan Francisco Gen. Hosp.
San Francisco, United States