{"id":68226,"date":"2021-11-16T09:43:13","date_gmt":"2021-11-16T08:43:13","guid":{"rendered":"https:\/\/www.pcb.ub.edu\/la-aemps-autoriza-el-ensayo-clinico-fase-iib-de-la-vacuna-de-hipra-contra-la-covid-19\/"},"modified":"2025-10-13T15:31:47","modified_gmt":"2025-10-13T13:31:47","slug":"la-aemps-autoriza-el-ensayo-clinico-fase-iib-de-la-vacuna-de-hipra-contra-la-covid-19","status":"publish","type":"post","link":"https:\/\/www.pcb.ub.edu\/es\/la-aemps-autoriza-el-ensayo-clinico-fase-iib-de-la-vacuna-de-hipra-contra-la-covid-19\/","title":{"rendered":"La AEMPS autoriza el inicio del ensayo cl\u00ednico Fase IIb de la vacuna de Hipra contra la Covid-19"},"content":{"rendered":"<p><strong>La farmac\u00e9utica\u00a0<a href=\"https:\/\/www.hipra.com\/portal\/es\/hipra\/home\" target=\"_blank\" rel=\"noopener\">Hipra<\/a>, con sede en Amer (Girona), ha recibido la autorizaci\u00f3n por parte de la Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (AEMPS) para iniciar la Fase IIb del ensayo cl\u00ednico de su vacuna contra la Covid-19. Se trata del primer ensayo en humanos de una vacuna contra el SARS-CoV-2 que se est\u00e1 desarrollando en Espa\u00f1a. El equipo que la multinacional tiene en su <a href=\"https:\/\/www.pcb.ub.edu\/es\/empresa\/hipra-scientific\/\" target=\"_blank\" rel=\"noopener noreferrer\">centro de I+D en el Parc Cient\u00edfic de Barcelona<\/a>\u00a0-donde se lleva a cabo una parte de la investigaci\u00f3n necesaria para el dise\u00f1o, generaci\u00f3n y caracterizaci\u00f3n de nuevos ant\u00edgenos vacunales- est\u00e1 participando activamente en el proyecto.<\/strong><\/p>\n<p>Los objetivos principales del ensayo de Fase IIb son confirmar la seguridad y tolerabilidad cuando se utiliza como <em>booster<\/em> y comprobar que esta dosis de refuerzo prolonga la respuesta inmunol\u00f3gica ante la Covid19 en personas ya vacunadas. La Fase IIb se inicia despu\u00e9s de que la Fase I\/IIa, aprobada por la AEMPS el pasado agosto, haya demostrado una buena tolerabilidad y ausencia de efectos adversos relevantes en la totalidad de los participantes.<\/p>\n<p>Est\u00e1 previsto que el ensayo cl\u00ednico comience en los pr\u00f3ximos d\u00edas en 10 hospitales espa\u00f1oles: Hospital Cl\u00ednic de Barcelona (Barcelona, Catalu\u00f1a), Hospital Universitari Dr. Josep Trueta (Girona, Catalu\u00f1a), Hospital Universitari Vall d\u2019Hebron (Barcelona, Catalu\u00f1a), Hospital Germans Trias i Pujol \u2013 Can Ruti (Badalona, Catalu\u00f1a), Hospital General Universitario Gregorio Mara\u00f1\u00f3n (Madrid, Comunidad de Madrid), Hospital Universitario La Paz (Madrid, Comunidad de Madrid), Hospital Universitario Pr\u00edncipe de Asturias (Alcal\u00e1 de Henares, Comunidad de Madrid), Hospital Universitario de Cruces (Barakaldo, Pa\u00eds Vasco), Hospital Regional Universitario Carlos Haya de M\u00e1laga (M\u00e1laga, Andaluc\u00eda) y Hospital Cl\u00ednico Universitario de Valencia (Valencia, Comunidad Valenciana).<\/p>\n<p>Se llevar\u00e1 a cabo con un total de 1.075 voluntarios mayores de 18 a\u00f1os, que hayan recibido la pauta completa de la vacuna Comirnaty de Pfizer-BioNTech hace 6 meses y que no hayan pasado la enfermedad.<\/p>\n<p>Si los resultados que se obtienen de la Fase IIb son favorables, se iniciar\u00e1 la Fase III inmediatamente, sumando m\u00e1s hospitales espa\u00f1oles y de otros pa\u00edses europeos y con un mayor n\u00famero de voluntarios.<\/p>\n<p>La vacuna contra la Covid-19 que est\u00e1 desarrollando Hipra es una vacuna de prote\u00edna recombinante que ha sido dise\u00f1ada para optimizar su seguridad y conseguir una potente respuesta inmunitaria neutralizadora del virus de la Covid-19. Se conservar\u00e1 entre 2 y 8\u00ba C, lo que facilitar\u00e1 la log\u00edstica y distribuci\u00f3n.<\/p>\n<p>La previsi\u00f3n es que la vacuna pueda estar disponible en el primer semestre de 2022, una vez obtenidas las autorizaciones oportunas.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La farmac\u00e9utica\u00a0Hipra, con sede en Amer (Girona), ha recibido la autorizaci\u00f3n por parte de la Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (AEMPS) para iniciar la Fase IIb del ensayo&#8230;<\/p>\n","protected":false},"author":4,"featured_media":68219,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[356],"tags":[],"class_list":["post-68226","post","type-post","status-publish","format-standard","has-post-thumbnail","category-empresas"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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