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24 de abril de 2024
estudio fase III
¿Quién se anota? reclutan voluntarios para probar una vacuna contra el Covid jueves 10 de septiembre de 2020 07:46 Siguen los estudios de comprobación de la vacuna contra el coronavirus
La Fundación Huésped anunció que comienza el reclutamiento de personas que quieran participar del estudio de fase III de una de las vacunas candidatas contra el coronavirus desarrollada en China por el CNBG (China National Biotech Group) y basada en virus inactivado, el segundo ensayo clínico que se pone en marcha en la Argentina para compuestos en etapas finales previas a su aprobación.
Las vacunas inactivadas utilizan una versión muerta del germen y hay otros ejemplos de este tipo como la de la gripe, la de la hepatitis A, la polio y la de la rabia, por lo cual ya se sabe que es imposible contraer la enfermedad a partir de la vacuna, lo que implica un enfoque tradicional.
El estudio, que fue aprobado ya por ANMAT, será aleatorizado (recibir la vacuna o el placebo dependerá del azar), de doble enmascaramiento (ni la persona voluntaria ni el equipo investigador saben si recibió la vacuna o el placebo), controlado con placebo (una sustancia inerte), en grupos paralelos para evaluar la inmunogenicidad (la capacidad de activar el sistema inmune) y la seguridad.
En los estudios de fase I y II más de 800 personas voluntarias recibieron esta vacuna con buenos resultados preliminares y sin efectos adversos serios. El estudio en la Argentina, que será llevado adelante en tres de los centros de Vacunar y es patrocinado por los Laboratorios Elea-Phoenix, durará 12 meses e incluirá 3.000 personas voluntarias, mayores de 18 años, que por su historia clínica y examen físico tengan un buen estado de salud y sean elegibles, tengan menos de 65 años y no estén gestando. Quienes quieran participar pueden inscribirse en https://estudios.huesped.org.ar/.