Efecto de 2 vacunas inactivadas contra el SARS-CoV-2 en la infección sintomática por COVID-19 en adultos: un ensayo clínico aleatorizado
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Ver abstracta en PubMed
Resumen
Este resumen es generado por máquina.Dos vacunas inactivadas contra el COVID-19 (SARS-CoV-2) demostraron una eficacia significativa en la prevención de la enfermedad sintomática. Los acontecimientos adversos graves fueron raros en este ensayo de fase 3, lo que indica un perfil de seguridad favorable para ambas vacunas.
Área De La Ciencia
- Vacunas y vacunas
- Enfermedades infecciosas
- Ensayos clínicos
Sus Antecedentes
- Las vacunas efectivas son cruciales para controlar la pandemia de COVID-19.
- Se necesitan vacunas candidatas adicionales para satisfacer la demanda mundial y abordar las posibles variantes.
Objetivo Del Estudio
- Evaluar la eficacia y seguridad de dos vacunas inactivadas contra el SARS-CoV-2.
- Para comparar el rendimiento de dos vacunas COVID-19 inactivadas distintas en un ensayo controlado aleatorio.
Principales Métodos
- Un ensayo aleatorizado, doble ciego, controlado con placebo de fase 3 en el que participaron adultos sin COVID-19 previo.
- Los participantes recibieron dos inyecciones intramusculares de una vacuna de SARS-CoV-2 inactivada (WIV04 o HB02) o un control solo de hidróxido de aluminio (alum).
- Se midió la eficacia frente al COVID-19 sintomático, y se evaluó la seguridad a través del monitoreo de eventos adversos.
Principales Resultados
- La eficacia de la vacuna contra el COVID-19 sintomático fue del 72,8% para WIV04 y del 78,1% para HB02 en comparación con el grupo de control.
- No se produjeron casos graves de COVID-19 en los grupos vacunados, frente a dos en el grupo de control.
- Las reacciones adversas fueron frecuentes pero leves, y los eventos adversos graves fueron raros y similares en todos los grupos.
Conclusiones
- Las dos vacunas de SARS-CoV-2 inactivadas son efectivas para prevenir el COVID-19 sintomático.
- Las vacunas presentan un perfil de seguridad favorable con raras reacciones adversas graves.
- Se está recopilando más datos para el análisis final de estas vacunas contra la COVID-19.
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