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Seguridad e inmunogenicidad de la vacuna ChAdOx1 nCoV-19 administrada en un régimen de refuerzo primario en adultos
Maheshi N Ramasamy1, Angela M Minassian2, Katie J Ewer2
1Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Lancet (London, England)
|November 22, 2020
Resumen
La vacuna ChAdOx1 nCoV-19 demostró una buena seguridad e inmunogenicidad similar en adultos de 70 años o más en comparación con adultos más jóvenes. Se recomiendan estudios adicionales de eficacia para todos los grupos de edad, incluidos aquellos con comorbilidades.
Área de la Ciencia:
- Vacunas y vacunas
- Inmunología
- Virología
Sus antecedentes:
- Los adultos mayores (≥70 años) enfrentan mayores riesgos de COVID-19, lo que los convierte en una prioridad para la vacunación.
- La inmunosenescencia puede afectar la inmunogenicidad de la vacuna en las poblaciones de edad avanzada.
- La vacuna ChAdOx1 nCoV-19 (AZD1222) vectorial en chimpancés se evaluó en un rango de edad más amplio, incluidos los ≥70 años.
Objetivo del estudio:
- Evaluar la seguridad y la inmunogenicidad de la vacuna ChAdOx1 nCoV-19 en adultos de 70 años o más.
- Comparar las respuestas inmunológicas y la tolerabilidad en diferentes grupos de edad (18-55, 56-69 y ≥70 años).
- Evaluar los esquemas de vacunación tanto de una como de dos dosis.
Principales métodos:
- Componente de la fase 2 de un ensayo aleatorizado y controlado (COV002) en el que participaron adultos sanos mayores de 18 años.
- Los participantes fueron estratificados en grupos de edad y asignados al azar para recibir ChAdOx1 nCoV-19 o una vacuna de control (MenACWY).
- Se midieron las respuestas inmunológicas humoral (ELISA, multiplex, microneutralización) y celular (IFN-γ ELISpot). Se monitoreó la seguridad y la reactividad.
Principales resultados:
- Las reacciones locales y sistémicas a ChAdOx1 nCoV-19 fueron menos frecuentes en adultos mayores (≥56 años) en comparación con los adultos más jóvenes.
- No se consideraron eventos adversos graves relacionados con las vacunas del estudio.
- Los títulos de IgG antipico y de anticuerpos neutralizantes fueron similares en todos los grupos de edad 28 días después de la dosis de refuerzo. También se observaron respuestas de células T en todas las cohortes de edad.
Conclusiones:
- ChAdOx1 nCoV-19 es mejor tolerado en adultos mayores que en adultos más jóvenes.
- La vacuna provoca una inmunogenicidad similar en todos los grupos de edad evaluados después de una dosis de refuerzo.
- Se requiere una evaluación adicional de la eficacia de la vacuna en todos los grupos de edad y en individuos con comorbilidades.
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