Baja respuesta de anticuerpos anti-RBD neutralizantes al esquema heterólogo Soberana 02/ Soberana Plus y datos de seguridad
Keywords:
vaccines, anti-COVID vaccines, neutralizing antibodies, SARS-CoV-2Abstract
Introducción: Los inmunógenos Soberanos fueron clave en el control de la COVID-19 en Cuba. Un paso en la reducción de riesgos de las estrategias de inmunización ante pandemias.
Objetivo: Caracterizar la respuesta subóptima de anticuerpos anti-RBD neutralizantes y documentar el perfil de seguridad.
Método: Se empleó un estudio observacional analítico y análisis diferenciado en una serie de 59 sujetos con respuestas subóptimas del inmunizados con el esquema heterólogo Soberana02/Soberana Plus, entre marzo-mayo de 2021 en Santiago de Cuba. Se utilizó una prueba de neutralización molecular de virus a una dilución sérica de 1/100. Una respuesta de inhibición de unión de RBD-ACE2 ˂70 %, se manejó como respuesta humoral subóptima, mientras que una ˂30 % manejó como respuesta humoral critica.
Resultado: La media aritmética de la respuesta de inhibición de unión de RBD-ACE2 fue de 40,74%. Para una respuesta humoral subóptima la menor proporción de pacientes estuvo en el grupo de controles respecto de vacunados: 40% vs. 22% (p=0,000). Para una respuesta humoral critica la menor proporción de afectados estuvo en el grupo de vacunados 8 % vs. 30 %(p=0,000). No se reportaron eventos adversos graves en los pacientes vacunados. Se mostraron dos tipos de eventos adversos, sin relación de causalidad definitiva y de intensidad leve: dolor en el sitio de inyección (46.6 %) y aumento de cifras tensionales (20 %).
Conclusiones: El esquema de inmunización estudiado, fue consistente con los resultados de los ensayos clínicos respecto a la potente respuesta de anticuerpos inhibitorios, con un perfil de seguridad adecuado.
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