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Inmunogenicidad y reactogenicidad del refuerzo BNT162b2 en participantes primados con ChAdOx1-S (CombiVacS): ensayo
Alberto M Borobia1, Antonio J Carcas1, Mayte Pérez-Olmeda2
1Servicio de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Hospital Universitario La Paz, IdiPAZ, Universidad Autónoma de Madrid, Madrid, Spain.
Lancet (London, England)
|June 28, 2021
Resumen
Una segunda dosis de la vacuna BNT162b2 (Comirnaty) después de la vacuna ChAdOx1-S (Vaxzevria) generó una fuerte respuesta inmune en adultos. Este esquema de vacunación heterólogo mostró un perfil de seguridad aceptable con efectos secundarios de leves a moderados.
Área de la Ciencia:
- Inmunología
- Vacunas y vacunas
- Salud pública
Sus antecedentes:
- Existen datos inmunológicos limitados para los programas de vacunación heteróloga contra el COVID-19 en humanos.
- Este estudio aborda la inmunogenicidad y la reactogenicidad de una segunda dosis de BNT162b2 después de la preparación primaria de ChAdOx1-S.
Objetivo del estudio:
- Evaluar la respuesta inmune y los efectos secundarios del uso de BNT162b2 como segunda dosis de la vacuna contra la COVID-19 en personas previamente vacunadas con ChAdOx1-S.
- Proporcionar datos cruciales sobre los programas de vacunación heterólogos.
Principales métodos:
- Un ensayo controlado aleatorizado de fase 2, abierto, en el que participaron 676 adultos de entre 18 y 60 años.
- Los participantes recibieron BNT162b2 como segunda dosis 8-12 semanas después de una dosis única de ChAdOx1-S.
- La inmunogenicidad se evaluó a través de los títulos de anticuerpos de proteína de punta y RBD, ensayos de neutralización y respuesta inmune celular; la seguridad se evaluó a través de eventos adversos.
Principales resultados:
- 14 días después de la vacunación con BNT162b2 se observaron aumentos significativos en los títulos de anticuerpos de RBD y de la proteína de pico trímero IgG.
- Se observaron altas proporciones de aumento de anticuerpos en comparación con el grupo de control.
- La mayoría de las reacciones adversas notificadas fueron leves a moderadas, incluyendo dolor en el lugar de la inyección, dolor de cabeza y mialgia, sin reacciones adversas graves.
Conclusiones:
- BNT162b2 como segunda dosis después de ChAdOx1-S induce una respuesta inmune robusta.
- El esquema de vacunación heteróloga demostró un perfil de reactividad aceptable y manejable.
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