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Butantan begins testing dengue vaccine in humans

Already successfully tested in the USA, the vaccine was effective against all four dengue viruses known

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Foto: Camila Carvalho/Instituto Butantan
In the U.S., the vaccine was tested in animals and humans, with positive results
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In the U.S., the vaccine was tested in animals and humans, with positive results

Researchers at the Butantan Institute in conjunction with the National Institutes of Health (NIH) in the United States managed to authorization of the National Agency for Sanitary Surveillance (ANVISA). In the United States to begin testing new vaccine against dengue vaccine in the country has been tested in animals and in humans in the U.S. with positive results.

Viruses were identified and modified in the United States and sent to the Butantan Institute, which was held culture and vaccine production in Brazil. The vaccine was tested in American volunteers was produced in the United States, there shown to be immunogenic (those produced antibodies against the four types of viruses). Now, researchers will test the vaccine produced in Brazil in Brazilian. The U.S. is not a country endemic for dengue. Therefore it is important to test the vaccine in Brazil, in a population at risk of contracting dengue, says Alexander Precious, director of the Division of Clinical Trials and Pharmacovigilance Instituto Butantan.

Tests performed in Brazil match the phase II study, which is divided into two parts. At first, 50 volunteers who will be vaccinated ever had dengue. This profile is more similar to the profile of the volunteers of the U.S., so we have a good comparison, explains precious. These first volunteers will be recruited by the Central Institute of the Hospital das Clinicas (HC), Faculty of Medicine, USP (USP). Are adults of both sexes and healthy.

The second part of the study will apply the vaccine in 250 other volunteers, recruited by the Central Institute and the Institute of the Child, both the HC of USP, and the Hospital of the Medical College of Ribierão Black (HCFMRP). These volunteers are also adults, but may or may not have had dengue before. The goal of the phase II studies, according to Alexander, is to demonstrate the safety profile of the vaccine, or to identify possible adverse effects both at the application site as the systemic effects, and verify that it is capable of leading to antibody production.

After testing the 300 volunteers, will start the phase III study. At this stage, will be recruited a much larger amount of volunteers, representing other regions of Brazil and different age groups. After this third step, the statistical results will tell if the vaccine really works. If the vaccine is safe and effective, it can finally be registered by ANVISA. The intention of the Instituto Butantan is it available to the Ministry of Health so that it enters the national immunization schedule, expect precious. The expectation is that the vaccine is available to the public in 2018.

<b> Four viruses </ b>

Precious to a major difficulty encountered in the production of the vaccine is the existence of four types of dengue viruses that cause - each with its own characteristics. The vaccine must protect people against the four viruses at the same time, the doctor explains.

There are different approaches to obtaining a vaccine: the use of recombinant proteins, inactivation or attenuation of viruses, among others. Vaccine tested by the Butantan Institute, the four viruses were attenuated, or suffered specific changes in their genome that become less active. Thus, the body of those who get the vaccine will identify the weakened virus and start producing antibodies against them, without, however, develop the disease. The criterion of choice [to this approach] Institute took into account the research partnership that exists between the Butantan and the NIH, and the fact that we believe that the use of attenuated viruses have the potential to cause the desired immunity, says the researcher.

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