01/07/2016 07H43 - Actualizado 1/07/2016 07H43

FMT y el Instituto Butantan para iniciar las pruebas de la vacuna contra el dengue, en Manaus

La Fundación de Medicina Tropical es una de las 14 centros de investigación elegidos, No brasil, para la última fase de los estudios sobre la vacuna.
foto: Valdo León / Secom
foto: Valdo León / Secom

La Medicina Tropical de la Fundación Dr. Heitor Vieira Dourado (FMT-HVD), vinculado al Departamento de Salud del Estado (sésamo), y el Instituto Butantan, Sao Paulo, Ellos comenzaron el jueves (30), en Manaus, pruebas de la vacuna contra el dengue, Es desarrollado por el instituto de investigación de Sao Paulo, con el apoyo del Ministerio de Salud. El FMT-HVD es una de 14 centros de investigación elegidos, No brasil, para llevar a cabo esta es la tercera y última fase de los estudios sobre la vacuna, antes de que pueda ser presentado a la Agencia Nacional de Vigilancia Sanitaria (Anvisa) para registro.

El anuncio de las pruebas en la capital amazónica se llevó a cabo en la Unidad Básica de Salud (UBS) Arthur Virgílio Hijo, el Municipal de Salud (sems), que será un socio de FMT en el estudio, en Manaus. de vez en cuando, los primeros voluntarios fueron vacunados.

Asistieron al evento, el director ejecutivo de FMT, la gracia de romero, el secretario municipal de Salud, Homero de Miranda Neto Hijo León, el director del Instituto Butantan, Jorge Kalil, Director de Enseñanza y la Investigación de la FMT, Marcus Lacerda, que coordinará el estudio en Manaus y CEO de la Fundación para la Vigilancia de la Salud (FVS-AM), Bernardino de Albuquerque, en representación del Secretario de Estado de Salud, Pedro Elías de Souza – que participa, en Brasilia, el Consejo Nacional de Secretarios de Salud de la Asamblea (CONASS).

En todo el país, prueba debe cubrir la vacunación y el seguimiento 17 miles de voluntarios, repartido 13 ciudades, de 12 estados, en las cinco regiones brasileñas. El presidente ejecutivo de la FMT, la gracia de romero, explica que, en Manaus, El estudio se establece la vacunación 1,2 miles de voluntarios, que será seguido por un período de 5 años, para verificar la eficacia y la duración de la protección de la vacuna. La previsión es que 1,2 son todos los voluntarios vacunados mil hasta un año.

Durante la rueda de prensa para explicar los detalles del estudio, Jorge Kalil dijo que en esta última etapa de la investigación, estudios apuntan a confirmar la eficacia de la vacuna. De los voluntarios totales, 2/3 recibirá la vacuna y 1/3 recibir placebo, una sustancia con las mismas características de la vacuna, pero sin virus, o sea, sin efecto. Ni el personal médico ni los participantes saben lo que los voluntarios recibirán la vacuna y que recibieron el placebo. El objetivo es descubrir, más adelante, a partir de las muestras obtenidas de voluntarios, si quien tomó la vacuna fue protegido y que tomaron el placebo contrajeron la enfermedad. "Los datos disponibles hasta el momento, las dos primeras fases del estudio, indican que la vacuna es segura, que induce el cuerpo para producir un anticuerpos de manera equilibrada contra todos los virus del dengue de cuatro que es potencialmente eficaz " ', dijo el director del Instituto Butantan.

A pesar de la vigilancia de los voluntarios debe ampliarse para 5 años, es posible que los resultados parciales de la solicitud de permiso de estudios de la inscripción de la nueva atAnvisa inmunobiológico antes de que la vacuna y pueden ser puestos a disposición del público por el Ministerio de Salud en dos o tres años. Kalil dijo que el Instituto Butantan tiene una fábrica pequeña escala para la vacuna preparada y equipada para producir el dengue 500 millones de dosis por año, capacidad se puede aumentar a hasta 12 millón de dosis / año con algunas adaptaciones industriales. El Butantan también tiene proyecto de construcción de una planta a gran escala que fabricará 60 millón de dosis / año. "Después de haber desarrollado y producido por una vacuna nacional productor público es una ventaja competitiva para Brasil, se asegura la disponibilidad del producto, lo que permite la autosuficiencia productiva, además de garantizar más asequible ", dijo.

El director del Instituto Butantan subrayó, todavía, la importancia de una asociación con el Gobierno de Amazonas, a través de la Fundación de Medicina Tropical, para este estudio, y dijo que la institución Amazon es capaz de ayudar con la prueba de varias otras vacunas en desarrollo. "La fundación tiene una muy buena estructura, para generar conocimiento y hacer la investigación. Por eso, estamos aqui", dijo.

El secretario municipal de Salud, Homero Miranda León, Dijo que este es un momento histórico para la salud pública en el mundo y dio las gracias al Susam y el Instituto Butantan de haber insertado una unidad de salud de atención primaria en este estudio como simbólica. "Estoy seguro de que será un éxito y tenemos el honor de contribuir", declarado.

metodología

Marcus Lacerda, que también es un investigador de la Fiocruz Amazonia, Se hace hincapié en que los voluntarios para las pruebas de vacuna contra el dengue serán elegidos por sorteo, entre los pacientes seguidos durante equipo de Salud de la Familia de UBS Arthur Virgílio. "Este criterio del sorteo es evitar que los voluntarios están, mayormente, personas que han tenido a menudo y el dengue, ciertamente, tendría mayor interés en participar en el estudio. El seleccionado al azar que tengan la intención de participar en el signo de pruebas de consentimiento plazo, con toda la información sobre el proceso de seguimiento, riesgos y beneficios. Es un proceso muy riguroso, dispuesto en el protocolo aprobado por el Comité de Ética en Investigación de las respectivas instituciones implicadas ", Said Lacerda.

En general, voluntarios deben ser mayores 2 un 59 años. Para fines de estudio, Ellos serán organizados en grupos 2 un 6 años; 7 un 17 años; mi 18 un 59 años. No pueden participar embarazada, personas que sufren de enfermedades crónicas como el cáncer - -, en tratamiento con quimioterapia, altas dosis de corticosteroides u otras situaciones de baja inmunidad.

Indicadores

Este año, Amazon tiene 10.655 casos de dengue notificados, y 6.187 en la capital, según datos de la Fundación para la Vigilancia de la Salud (FVS), Vinculada en Susam.

permanecer en: Para una vacuna pueden estar disponibles, un riguroso proceso debe ser seguido. Según lo explicado por el Instituto Butantan, antes ofrecida a la población, La vacuna se estudió en modelos animales (los llamados estudios preclínicos). En seguida, Se necesita ser estudiado en humanos (estudios clínicos). En la fase I de esta etapa, El objetivo es demostrar que la vacuna es capaz de ser utilizado en los seres humanos. En seguida, en la Fase II, observado la capacidad de la vacuna para estimular el sistema inmune para producir anticuerpos. En la Fase III - que está en curso - se solicita la prueba de que la persona vacunada está protegido contra la infección.

Además de Sao Paulo (capital), São José do Rio Preto (SP), Manaos y Boa Vista, donde ya se ha iniciado el estudio, las pruebas también se llevan a cabo en las ciudades de Porto Velho, Aracaju, Recife, fortaleza, Brasilia, Cuiaba, Campo Grande y Belo Horizonte.

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