01/07/2016 07h43 - Updated 1/07/2016 07h43

FMT and Butantan Institute to initiate testing of the vaccine against dengue, In Manaus

The Tropical Medicine Foundation is one of the 14 research centers chosen, no Brasil, for the last phase of studies on the vaccine.
Photo: Valdo Lion / Secom
Photo: Valdo Lion / Secom

The Tropical Medicine Foundation Dr Heitor Vieira Dourado (FMT-HVD), linked to the State Department of Health (Sesame), and the Butantan Institute, from Sao Paulo, They started on Thursday (30), In Manaus, testing the vaccine against dengue, It is developed by the São Paulo research institution, with support from the Ministry of Health. The FMT-HVD is one of 14 research centers chosen, no Brasil, to perform this is the third and final phase of the studies on the vaccine, before it can be submitted to the National Sanitary Surveillance Agency (Anvisa) registration.

The announcement of the tests in the Amazonian capital took place in the Basic Health Unit (UBS) Arthur Virgílio Son, the Municipal Health (Sems), which will be a partner of FMT in the study, In Manaus. In this ocasion, the first volunteers were vaccinated.

Attended the event, the chief executive of FMT, Rosemary grace, the municipal secretary of Health, Homero de Miranda Neto Lion Son, the director of the Butantan Institute, Jorge Kalil, Director of Teaching and Research of FMT, Marcus Lacerda, who will coordinate the study in Manaus and CEO of the Foundation for Health Surveillance (FVS-AM), Bernardino Albuquerque, representing the state Secretary of Health, Pedro Elias de Souza – involved, in Brasilia, the National Council of Secretaries of Health Assembly (Conass).

All over the country, test should cover vaccination and monitoring 17 thousand volunteers, distributed 13 cities, from 12 States, in the five Brazilian regions. The chief executive of FMT, Rosemary grace, explain what, In Manaus, The study provides for the vaccination 1,2 thousand volunteers, which will be followed for a period of 5 years, to verify the efficacy and duration of vaccine protection. The forecast is that 1,2 are all vaccinated volunteers thousand up to one year.

During the press conference to explain the details of the study, Jorge Kalil said that in this last stage of the research, studies aim to confirm the efficacy of the vaccine. Of the total volunteers, 2/3 will receive the vaccine and 1/3 receive placebo, a substance with the same vaccine characteristics, but without virus, that is, no effect. Neither the medical staff nor the participants know which volunteers receive the vaccine and who received the placebo. The goal is to discover, later, from samples collected from volunteers, if who took the vaccine was protected and who took the placebo contracted the disease. "The data available so far, the first two phases of the study, indicate that the vaccine is safe, which induces the body to produce a balanced manner antibodies against all four dengue virus which is potentially effective " ', said the director of the Butantan Institute.

Although the monitoring of volunteers should be extended for 5 years, it is possible that the partial results of the study permit request the registration of the new immunobiological atAnvisa before it and the vaccine can be made available to the public by the Ministry of Health in two or three years. Kalil said that the Butantan Institute has a small-scale factory for the vaccine ready and equipped to produce dengue 500 million doses per year, capacity can be increased to up 12 million doses / year with some industrial adaptations. The Butantan also has project to build a large-scale plant that will manufacture 60 million doses / year. "Having developed and produced by a national public producer vaccine is a competitive advantage for Brazil, it ensures product availability, allowing productive self-sufficiency, besides ensuring more affordable ", he said.

The director of the Butantan Institute stressed, still, the importance of a partnership with the Government of Amazonas, through the Tropical Medicine Foundation, for this study, and said the Amazon institution is able to help with testing several other vaccines in development. "The foundation has a very good structure, to generate knowledge and do research. That is why, we're here", he said.

The municipal secretary of Health, Homero Miranda Lion, He said this is a historic moment for public health in the world and thanked the Susam and Butantan Institute to have inserted a health unit of primary care in this study as symbolic. "I'm sure it will be a success and we are honored to contribute", stated.

Methodology

Marcus Lacerda, who is also a researcher at Fiocruz Amazon, It stresses that volunteers for dengue vaccine tests will be chosen by lot, among patients followed for Health team of the Family of UBS Arthur Virgílio. "This criterion of the draw is to avoid that the volunteers are, predominantly, people who have had dengue often and, of course, would have greater interest in participating in the study. The randomly selected who intend to participate in the sign of consent term tests, with all the information about the monitoring process, risks and benefits. It is a very rigorous process, provided in protocol approved by the Ethics Committee in Research of the respective institutions involved ", said Lacerda.

In general, volunteers must be aged 2 a 59 years. For study purposes, They will be organized in groups 2 a 6 years; 7 a 17 years; e 18 a 59 years. They can not participate pregnant, people suffering from chronic diseases - such as cancer -, under treatment with chemotherapeutic, high doses of corticosteroids or other situations of low immunity.

Indicators

In this year, Amazon has 10.655 dengue cases reported, and 6.187 in capital, according to data from the Foundation for Health Surveillance (FVS), vinculada in Susam.

Stay in: For a vaccine can be made available, a rigorous process must be followed. As explained by the Butantan Institute, before offered to the population, The vaccine is studied in animal models (the so-called preclinical studies). Then, It needs to be studied in humans (clinical studies). In phase I of this stage, The objective is to demonstrate that the vaccine is able to be used in humans. Then, in Phase II, observed the ability of the vaccine to stimulate the immune system to produce antibodies. In Phase III - which is in progress - the proof is sought that the vaccinated person is protected against infection.

Besides São Paulo (capital), Sao Jose do Rio Preto (SP), Manaus and Boa Vista, where the study is already started, the tests also take place in the cities of Porto Velho, Aracaju, Recife, Fortress, Brasilia, Cuiaba, Campo Grande and Belo Horizonte.

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