Vacuna de polisacárido meningocócico del grupo C conjugada con toxoide tetánico. Un meta-análisis de la inmunogenicidad, seguridad y posología / Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine. A Meta-Analysis of Immunogenicity, Safety and Posology
Pediátrika (Madr.)
; Pediátrika (Madr.);27(2): 58-71, feb. 2007. ilus, tab
Article
en Es
| IBECS
| ID: ibc-64702
Biblioteca responsable:
ES15.1
Ubicación: ES15.1 - BNCS
La vacuna que contiene polisacárido de meningococodel grupo C de-O-acetilado, conjugada con toxoidetetánico (GCMP-TT), se ha autorizado en 32países y se ha incorporado en un programa de vacunaciónrutinaria en el Reino Unido. Rápidamentese ha acumulado una gran experiencia, que es elobjeto de este meta-análisis, sobre la inmunogenicidad,seguridad y posología de GCMP-TT, así comosobre su impacto epidemiológico. GCMP-TT ha demostradoser efectiva tras una dosis única en individuosmayores de 12 meses de edad y su posologíainicial especificaba tres dosis en lactantes. Sin embargo,según un ensayo clínico reciente, la posologíase redujo a dos dosis en lactantes. La tasa deprotección recogida, definida como la proporción deindividuos con títulos de anticuerpos bactericidas ensuero (SBA) ≥1:8, fue del 99,4% (CI, 98.2-99.9%) ensiete estudios clínicos que abarcan todos los gruposde edad. Se han demostrado respuestas fuertes aGCMP-TT con respecto a SBA, niveles de IgG y deavidez a los anticuerpos. En la farmacovigilanciadespués de la comercialización, que abarca >12 x106 GCMP-TT dosis distribuidas por todo el mundo,la vacuna ha sido bien tolerada con una tasa de incidenciade 0,01% para todos los tipos de efectos adversosmás comúnmente encontrados. Después deuna campaña de vacunación general en el ReinoUnido, en la que a los niños de 5-8 años se les dioprimeramente GCMP-TT, se observó una disminucióndel 93% en la incidencia de enfermedad meningocócica.A la vista de esta inmunogenicidad, seguridady adaptación potencial al uso en lactantes enprogramas de posología reducida, la vacuna GCMPTTmarca un mayor avance sobre las vacunas depolisacárido predecesoras en la prevención de enfermedadmeningocócica C
A conjugate vaccine comprised of de-O-acetylatedgroup C meningococcal polysaccharide coupledto tetanus toxoid (GCMP-TT) has been licensed in32 countries and incorporated in a comprehensiveUK vaccination program. Extensive evidence, formingthe subject of this meta-analysis, has rapidlyaccumulated on the immunogenicity, safety and posologyof GCMP-TT as well as its epidemiologicalimpact. GCMP-TT has been shown effective after asingle dose in individuals > 12 months of age, andinitial posology specified three doses in infants. However,based on a recent clinical trial, posology wasreduced to two doses in infants. Pooled protectionrate, defined as proportion of subjects with serumbactericidal antibody (SBA) levels 1:8, was 99.4%(CI, 98.2-99.9%) in 7 clinical trials covering all agegroups. Robust responses to GCMP-TT have been demonstrated with respect to SBA, IgG levels andantibody avidity. In post-marketing pharmacosurveillanceencompassing > 12*106 GCMP-TT doses distributedworldwide, the vaccine has been well toleratedwith an incidence rate of 0.01% for all the mostcommonly encountered types of adverse events. Aftera catch-up UK vaccination campaign where 5-8year old children were primarily given GCMP-TT, a93% decline in meningococcal disease incidencewas observed. In view of its immunogenicity, safetyand potential suitability for use among infants in reduceddose schedules, GCMP-TT appears to marka major advance over predecessor polysaccharidevaccines for the prevention of meningococcal C disease
A conjugate vaccine comprised of de-O-acetylatedgroup C meningococcal polysaccharide coupledto tetanus toxoid (GCMP-TT) has been licensed in32 countries and incorporated in a comprehensiveUK vaccination program. Extensive evidence, formingthe subject of this meta-analysis, has rapidlyaccumulated on the immunogenicity, safety and posologyof GCMP-TT as well as its epidemiologicalimpact. GCMP-TT has been shown effective after asingle dose in individuals > 12 months of age, andinitial posology specified three doses in infants. However,based on a recent clinical trial, posology wasreduced to two doses in infants. Pooled protectionrate, defined as proportion of subjects with serumbactericidal antibody (SBA) levels 1:8, was 99.4%(CI, 98.2-99.9%) in 7 clinical trials covering all agegroups. Robust responses to GCMP-TT have been demonstrated with respect to SBA, IgG levels andantibody avidity. In post-marketing pharmacosurveillanceencompassing > 12*106 GCMP-TT doses distributedworldwide, the vaccine has been well toleratedwith an incidence rate of 0.01% for all the mostcommonly encountered types of adverse events. Aftera catch-up UK vaccination campaign where 5-8year old children were primarily given GCMP-TT, a93% decline in meningococcal disease incidencewas observed. In view of its immunogenicity, safetyand potential suitability for use among infants in reduceddose schedules, GCMP-TT appears to marka major advance over predecessor polysaccharidevaccines for the prevention of meningococcal C disease
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Bases de datos:
IBECS
Asunto principal:
Vacunas Neumococicas
/
Infecciones Meningocócicas
Tipo de estudio:
Clinical_trials
/
Systematic_reviews
Límite:
Humans
Idioma:
Es
Revista:
Pediátrika (Madr.)
Año:
2007
Tipo del documento:
Article