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Efecto de la vacuna de vesículas de membrana externa contra la enfermedad meningocócica del grupo B en Noruega
G Bjune1, E A Høiby, J K Grønnesby
1National Institute of Public Health, Oslo, Norway.
Lancet (London, England)
|November 2, 1991
Resumen
Una vacuna meningocócica B de membrana externa mostró una eficacia del 57,2% en un gran ensayo noruego. Si bien es protectora, la vacuna también lo es.
Área de la Ciencia:
- Enfermedades infecciosas Enfermedades infecciosas.
- Vacunología Vacunología.
- Epidemiología La epidemiología.
Sus antecedentes:
- Noruega tiene la mayor incidencia de enfermedad meningocócica en el norte de Europa.
- Los meningococos del serogrupo B causan el 80% de los casos, con una alta tasa de mortalidad de aproximadamente el 10%.
Objetivo del estudio:
- Evaluar la eficacia de una vacuna de vesícula de membrana externa (VMO) contra la enfermedad meningocócica del serogrupo B.
- Para determinar si el nivel de protección de la vacuna justifica un programa público de vacunación.
Principales métodos:
- Un ensayo de eficacia a gran escala, aleatorizado, doble ciego y controlado con placebo en el que participaron 171.800 estudiantes de secundaria en Noruega.
- La escuela era la unidad de aleatorización.
- Informe urgente de sospecha de meningitis y/o casos de septicemia en estudiantes de entre 13 y 21 años.
Principales resultados:
- Se confirmaron 89 casos de enfermedad sistémica grave debido a meningococos del grupo B.
- Se produjeron 36 casos dentro del ensayo (11 escuelas vacunadas, 24 escuelas de placebo).
- La eficacia calculada de la vacuna fue del 57,2% (p = 0,012).
Conclusiones:
- La vacuna meningocócica B OMV confirió protección contra la enfermedad meningocócica del grupo B.
- La eficacia observada fue insuficiente para justificar un programa público de vacunación.
- Puede ser necesaria más investigación para mejorar la efectividad de la vacuna o explorar estrategias alternativas.
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