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Ébola : um fim à vista? Revisão narrativa sobre o processo de aprovação da primeira vacina contra doença por vírus ébola
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Orientador(es)
Resumo(s)
A doença por vírus Ébola (DVE) é uma doença zoonótica grave, com alta taxa de letali-dade, causada pela infeção por vírus Ébola (EBOV). Isolados em 1976, os Ebolavirus têm sido identificados em vários surtos no continente africano, com principal destaque para o surto ocorrido em 2014-2016 na África Ocidental e o atual, a decorrer desde agosto de 2018, na República Democrática do Congo (RDC).
Ervebo®, uma vacina viva atenuada do vírus recombinante da estomatite vesicular, a apresentar a glicoproteína de membrana de EBOV (rVSVΔG-ZEBOV-GP), foi, recente-mente, aprovada pelas entidades reguladoras de diversos países para o uso em adultos saudáveis, depois de ter demonstrado um bom perfil de segurança, imunogenicidade e eficácia, tendo já um papel ativo nos surtos referidos, com mais de 300.000 indivíduos vacinados na RDC.
Esta revisão narrativa pretende identificar as características clínicas da DVE e acompa-nhar o percurso da vacina Ervebo® até à licença, descrevendo as principais conclusões pré-clínicas e clínicas que motivaram a sua aprovação.
Ebola virus disease (EVD) is a severe zoonotic disease with a very high fatality rate caused by infection with Ebola virus (EBOV). Isolated in 1976, the Ebolavirus have been identified in outbreaks in the African continent, of note the 2014-2016 outbreak in West-ern Africa and the current outbreak, ongoing since August 2018, in the Democratic Re-public of Congo (DRC). Ervebo®, a live attenuated vaccine of the recombinant vesicular stomatitis virus present-ing the membrane glycoprotein of EBOV (rVSVΔG-ZEBOV-GP), was recently approved by the regulatory authorities of different countries for the use in healthy adults, after demonstrating a safety, immunologic and effective profile in clinical studies, already hav-ing an active role in the mentioned outbreaks, with more than 300,000 individuals vac-cinated in DRC. This narrative review aims to identify the clinical features of EVD and define the Ervebo® vaccine pathway to licensure, whilst describing the preclinical and clinical data that motivated its approval.
Ebola virus disease (EVD) is a severe zoonotic disease with a very high fatality rate caused by infection with Ebola virus (EBOV). Isolated in 1976, the Ebolavirus have been identified in outbreaks in the African continent, of note the 2014-2016 outbreak in West-ern Africa and the current outbreak, ongoing since August 2018, in the Democratic Re-public of Congo (DRC). Ervebo®, a live attenuated vaccine of the recombinant vesicular stomatitis virus present-ing the membrane glycoprotein of EBOV (rVSVΔG-ZEBOV-GP), was recently approved by the regulatory authorities of different countries for the use in healthy adults, after demonstrating a safety, immunologic and effective profile in clinical studies, already hav-ing an active role in the mentioned outbreaks, with more than 300,000 individuals vac-cinated in DRC. This narrative review aims to identify the clinical features of EVD and define the Ervebo® vaccine pathway to licensure, whilst describing the preclinical and clinical data that motivated its approval.
Descrição
Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2020
Palavras-chave
Doença por vírus Ébola Vacina Ervebo® rVSVΔG-ZEBOV-GP