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Efecto de una vacuna en investigación para prevenir infecciones por Staphylococcus aureus después de una cirugía

Vance G Fowler¹, Keith B Allen, Edson D Moreira

¹Duke University Medical Center, Hanes Bldg, Room 153, Trent Drive, PO Box 102359, Durham, NC 27710, USA. fowle003@mc.duke.edu

|April 4, 2013

Resumen

La vacuna V710 no impidió las infecciones por Staphylococcus aureus después de la cirugía cardiotorácica y se relacionó con una mayor mortalidad en pacientes infectados. Estos hallazgos no apoyan su uso en pacientes quirúrgicos.

Área de la Ciencia:

Enfermedades infecciosas Enfermedades infecciosas.
Vacunología Vacunología.
Cirugía cardiotorácica Cirugía cardiotorácica es una cirugía para el corazón.

Sus antecedentes:

Las infecciones por Staphylococcus aureus presentan serios riesgos después de una cirugía cardiotorácica.
Se desarrolló un nuevo candidato a vacuna, V710, dirigido al determinante B de la superficie de hierro de S. aureus, y mostró inmunogenicidad en voluntarios.

Objetivo del estudio:

Evaluar la eficacia y seguridad de la vacunación preoperatoria V710 en la prevención de infecciones graves postoperatorias por S. aureus en pacientes sometidos a cirugía cardiotorácica.

Principales métodos:

Un ensayo doble ciego, aleatorizado y basado en eventos que involucró a 8031 pacientes programados para una esternotomía mediana.
Los participantes recibieron la vacuna V710 (60 μg) o placebo por vía intramuscular.
Endpoint primario: prevención de la bacteremia por S. aureus y/o infección de herida sternal profunda hasta el día 90 postoperatorio.

Principales resultados:

El estudio se terminó antes de tiempo debido a preocupaciones de seguridad y baja eficacia.
La vacuna V710 no mostró eficacia significativa sobre el placebo en la prevención de infecciones primarias o secundarias por S. aureus.
La vacuna V710 se asoció con más experiencias adversas y una mayor tasa de insuficiencia multiorgánica.
La mortalidad entre los pacientes que desarrollaron infecciones por S. aureus fue significativamente mayor en el grupo V710.

Conclusiones:

La vacunación preoperatoria V710 no redujo las infecciones graves postoperatorias por S. aureus en pacientes sometidos a cirugía cardiotorácica.
La vacuna se asoció con un aumento de la mortalidad en pacientes que contrajeron infecciones por S. aureus.
Estos resultados no apoyan el uso de la vacuna V710 para pacientes sometidos a intervenciones quirúrgicas.

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