Primeira fase do ensaio clínico convidará voluntários adultos que receberão duas doses do candidato a imunizante; segundo momento da pesquisa deve incluir mais velhos
POR IMPRENSA BUTANTAN (imprensa@butantan.gov.br)
O Instituto Butantan, órgão ligado à Secretaria do Estado da Saúde de São Paulo, recebeu na terça-feira (1º) a aprovação da Agência Nacional de Vigilância Sanitária (Anvisa) para o início dos ensaios em humanos, da sua candidata à vacina contra a Gripe Aviária A (H5N8). Para isso, o Instituto pretende recrutar 700 adultos e idosos voluntários que participarão das fases 1/2 do Estudo em cinco Centros de Pesquisa brasileiros.
A Vacina Influenza Mmonovalente A (H5N8) (inativada, fragmentada e adjuvada) será testada em duas doses com intervalo de 21 dias, primeiramente em adultos de 18 anos até 59 anos e 11 meses e depois em pessoas com 60 ou mais. O Instituto Butantan concluiu os estudos pré-clínicos com resultados favoráveis de segurança e imunogenicidade.
“Estamos em conversas com o Ministério da Saúde, que se mostrou sensível ao avanço dessa discussão. Com a Plataforma aprovada, o Instituto pode produzir um contingente de 30 milhões de doses após os resultados iniciais. Este contingente estratégico pode ser utilizado caso o vírus comece a se disseminar entre humanos e tenha antígenos semelhantes aos representados pela vacina candidata do Instituto Butantan”, afirma o Diretor do Instituto Butantan, Esper Kallás.
O Ministério da Saúde publicou em dezembro de 2024 um Plano de Contingência Nacional do Setor Saúde para Influenza Aviária no qual define as estratégias que deve adotar em caso de situação de emergência relacionada à doença. Uma delas é prover estoques estratégicos de medicamentos e insumos que possam combater a disseminação da doença.
Como será o Estudo?
Inicialmente serão recrutados 70 adultos, que receberão as doses por via intramuscular, em um Centro de Pesquisa no Recife (PE) e, posteriormente, em quatro Centros de Pesquisa localizados em São Paulo (SP), Belo Horizonte (MG), São José do Rio Preto (SP) e em Ribeirão Preto (SP).
O Estudo vai avaliar a segurança e a capacidade de gerar resposta imune contra a Gripe Aviária (imunogenicidade) de duas formulações da vacina, em comparação com Placebo. O estudo permitirá a escolha da dose da vacina.
Um Comitê Independente de Monitoramento de Dados e Segurança vai fazer a análise de segurança do estudo que inclui, entre outras ações, a avaliação preliminar dos dados de segurança dos 70 primeiros adultos recrutados, após a aplicação da primeira dose. Caso a avaliação seja positiva, abre-se uma nova etapa de recrutamento para incluir mais 280 adultos na Pesquisa.
Se o perfil de segurança for favorável na população adulta testada, inicia-se a segunda fase do estudo, na qual haverá o recrutamento de 70 pessoas com 60 anos ou mais. Novamente, se a avaliação de segurança da candidata vacinal for favorável, segue com o recrutamento de voluntários com 60 anos ou mais até completar 350 voluntários. O objetivo é terminar o acompanhamento destes participantes em 2026 e ter um pacote regulatório que contempla uma faixa etária ampla para ser submetido à Anvisa.
“Se durante o Ensaio Clínico for decretada uma epidemia, o Butantan fica à disposição da Anvisa para ver o que pode ser feito para encurtar prazos e adaptar a vacina para contemplar uma diferente variante do vírus da Influenza Aviária”, afirma a Diretora Médica do Butantan, Fernanda Boulos. “Se isso não ocorrer, o estudo permanece sendo referente ao desenvolvimento de uma vacina pré-pandêmica, tornando o Butantan pioneiro em seu desenvolvimento no Brasil e com capacidade de fornecer o produto em caso de necessidade”, reforça a Diretora.
Lote reserva
O Instituto começou a estudar a possibilidade de fazer uma vacina contra a Gripe Aviária ainda em 2023. O processo está sendo desenvolvido com a cepa do vírus Influenza tipo A (H5N8), fornecida ao Instituto Butantan pelo Centro de Controle e Prevenção de Doenças dos Estados Unidos (CDC).
Durante o desenvolvimento da vacina contra Gripe Aviária – incluindo os ensaios pré-clínicos – foi incluída na vacina uma Cepa H5 de importância epidemiológica atual, por se tratar de uma variante altamente patogênica que mais se aproxima da Cepa circulante nas Américas. Com isso, o Butantan já tem disponível um lote reserva de vacinas pronto para ser usado na pesquisa clínica.
Em 2018, o Instituto chegou a fazer Estudo Fase 1 com uma outra vacina pandêmica de Gripe Aviária A (H7N9), em parceria com Organização Mundial de Saúde (OMS), com a Autoridade de Pesquisa e Desenvolvimento Biomédico Avançado do Departamento de Saúde e Serviços Humanos dos Estados Unidos (BARDA), e com o Instituto de Pesquisa em Doenças Infecciosas dos Estados Unidos (IDRI). Na lógica da preparação para pandemia, houve mudança de rota, devido ao avanço dos casos de Gripe A (H5N1).
“Fomos testando lotes, cada um com três candidatas vacinais, para avaliar o rendimento e a produtividade de cada Cepa. Com base na melhor escolha, avançou-se para os estudos pré-clínicos coordenados pela equipe da Diretora do Centro de Desenvolvimento e Inovação do Butantan, Ana Marisa Chudzinski-Tavassi”, afirma o Diretor do Centro Bioindustrial do Butantan, Ricardo Oliveira.
Risco de pandemia preocupa
A transmissão da Gripe Aviária em humanos, considerada esporádica, ocorre após contato próximo com uma ave infectada e/ou suas fezes. A forma de transmissão mais plausível é o contato com as penas, pele, mucosas e aerossóis, isto é, pela manipulação do animal infectado vivo ou morto – este último na manipulação em frigoríficos, por exemplo – e depois de encostar a mão contaminada nos olhos, nariz ou boca, segundo a OMS.
Não há, até o momento, comprovação da transmissão do vírus de humano para humano, embora um artigo da revista Science relata a possibilidade cada vez mais próxima de isso ocorrer devido às mutações do vírus – se antes ele só atingia aves, agora já infecta vacas e humanos que têm contato com os bovinos.
A possível disseminação entre pessoas preocupa cientistas pela alta mortalidade do vírus em humanos (próxima de 50%), e pela gravidade dos sintomas, que podem variar de uma conjuntivite com sintomas leves de Gripe a uma Doença Respiratória Aguda Grave, levando à morte.
“O vírus de Influenza A(H5N1) está sendo transmitido de aves para aves, de aves para mamíferos, de mamíferos para mamíferos, de aves para humanos e mamíferos para humanos. Só não vimos ainda a transmissão de pessoa para pessoa, mas existe um potencial do vírus adquirir essa capacidade, o que é muito perigoso porque aumenta o risco de uma pandemia”, afirma o Pesquisador Científico e Gerente de Desenvolvimento e Inovação de Produtos do Butantan, Paulo Lee Ho.
No Brasil não há casos registrados da doença em pessoas, embora este ano tenha sido notificado pelo Ministério da Agricultura e Pecuária (MAPA) a infecção em aves comerciais de uma granja no município de Montenegro (RS) e de outros Estados do país, que estão sob investigação. A pasta esclarece que está rastreando as granjas com atuais focos e adotando medidas sanitárias nos locais, nas proximidades e entre pessoas que trabalham nas granjas.
O país já havia notificado um foco de infecção em aves silvestres em 2023. “Ter uma vacina pronta, com uma Plataforma já testada, que mostra que produz anticorpos contra o vírus, é o objetivo do Butantan. Não é para já comercializar, mas para propor um estoque estratégico”, afirma o Diretor do Butantan, Esper Kallás.
Foto: imprensa butantan
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