Salud
El Reino Unido pronto expondrá a los voluntarios a Covid en el primer estudio de «desafío humano» del mundo
El Reino Unido se convertirá en el primer país del mundo en realizar un estudio de «desafío humano» Covid-19, tras la aprobación del organismo de ética de ensayos clínicos del país.
El primer ensayo de desafío humano de Covid-19 verá hasta 90 voluntarios, de entre 18 y 30 años, expuestos a Covid-19 «en un entorno seguro y controlado para aumentar la comprensión de cómo el virus afecta a las personas», dijo el gobierno británico en un comunicado. Miércoles.
Los investigadores están pidiendo a los jóvenes sanos, que tienen el menor riesgo de complicaciones derivadas del coronavirus, que se ofrezcan como voluntarios para el estudio. Los voluntarios serán compensados por el tiempo que pasen en el estudio, que comenzará dentro de un mes.
El estudio cuenta con el respaldo de una inversión de 33,6 millones de libras esterlinas (46,6 millones de dólares) del gobierno británico, y el ensayo se realiza mediante una asociación entre el Grupo de Trabajo de Vacunas del gobierno, el Imperial College London, la Royal Free London NHS Foundation Trust y la empresa clínica hVIVO. que ha sido pionero en modelos de desafío humano viral.
Cómo funciona
El estudio implicará establecer la cantidad más pequeña de virus necesaria para causar la infección (conocido como estudio de caracterización de virus) con voluntarios expuestos «en un ambiente seguro y controlado», dijo el gobierno.
«La seguridad de los voluntarios es primordial, lo que significa que este estudio de caracterización del virus utilizará inicialmente la versión del virus que ha estado circulando en el Reino Unido desde marzo de 2020 y ha demostrado ser de bajo riesgo en adultos jóvenes sanos», agregó. Los médicos y científicos supervisarán de cerca el efecto del virus en los voluntarios y estarán disponibles para cuidarlos las 24 horas del día.
El estudio ayudará a los médicos a comprender cómo reacciona el sistema inmunológico al coronavirus e identificar los factores que influyen en la forma en que se transmite el virus, incluida la forma en que una persona infectada con Covid-19 transmite partículas de virus infecciosos al medio ambiente.
Una vez que se ha realizado el estudio inicial, los participantes podrían recibir una vacuna aprobada y luego exponerse al virus Covid-19 para identificar las vacunas más efectivas.
Consideraciones
Dichos ensayos no están exentos de controversia dado que los participantes están expuestos deliberadamente a patógenos, pero se considera que desempeñan un papel clave en el desarrollo de vacunas y tratamientos efectivos.
“Durante muchas décadas, los estudios sobre desafíos humanos se han realizado de manera segura y han desempeñado un papel importante en la aceleración del desarrollo de tratamientos para enfermedades como la malaria, la fiebre tifoidea, el cólera, el norovirus y la gripe”, señaló el gobierno británico.
La guía de la Organización Mundial de la Salud dice que los ensayos de desafío en humanos son éticos cuando cumplen con ciertos criterios. Las protecciones deben estar claramente establecidas, dijeron los expertos, incluido que los participantes del ensayo son relativamente jóvenes, gozan de buena salud y reciben atención médica de la más alta calidad con un seguimiento frecuente.
La OMS señala que es esencial que los ensayos de impugnación se «lleven a cabo dentro de un marco ético en el que se otorgue un consentimiento verdaderamente informado» y que se realicen con «mucha previsión, precaución y supervisión».
Se deben tener en cuenta tanto los posibles riesgos y beneficios individuales, dice la OMS, como los posibles beneficios y riesgos sociales, como la liberación al medio ambiente de un patógeno que de otro modo no estaría presente.
El ensayo de desafío humano del Reino Unido se llevará a cabo en las próximas semanas en las instalaciones de investigación clínica seguras y especializadas del Royal Free Hospital en Londres. Estas instalaciones “están diseñadas específicamente para contener el virus. Médicos y científicos altamente capacitados estarán disponibles para examinar cuidadosamente cómo se comporta el virus en el cuerpo y garantizar la seguridad de los voluntarios «.
Carrera contra variantes
La aprobación para el ensayo de desafío humano, del Comité de Ética del Reino Unido, se produce la misma semana en que el Reino Unido alcanzó su objetivo de ofrecer una primera dosis de una vacuna contra el coronavirus a 15 millones de personas en sus cuatro principales grupos prioritarios, incluida la atención médica. trabajadores, ancianos y mayores de 70 años.
Existe una urgencia en el lanzamiento de la vacuna debido a las preocupaciones sobre la propagación de variantes del virus, con una cepa particular que surgió en el Reino Unido a fines del año pasado y ahora es la versión dominante en Gran Bretaña y se detectó en más de 80 países en todo el mundo. No obstante, hasta ahora los estudios preliminares han demostrado que las vacunas actuales contra el coronavirus siguen siendo eficaces contra nuevas variantes del virus.
Clive Dix, presidente interino del Grupo de Trabajo sobre Vacunas del Reino Unido, comentó que los ensayos de desafío en humanos eran vitales para comprender mejor el virus y la eficacia de las vacunas.
“Hemos asegurado una serie de vacunas seguras y efectivas para el Reino Unido, pero es esencial que continuemos desarrollando nuevas vacunas y tratamientos para Covid-19. Esperamos que estos estudios ofrezcan información única sobre cómo funciona el virus y nos ayuden a comprender qué vacunas prometedoras ofrecen las mejores posibilidades de prevenir la infección ”.
Fuente: CNBC
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