Dengue vaccine is applied for testing in humans

Agência Brasil - The tests of the third and final stage of the dengue vaccine, which had been done since February with 1.2 thousand volunteers recruited by the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (USP), began to be held this Thursday (23), with 1.2 thousand volunteers at the School of Medicine of São José do Rio Preto (Famerp), in the interior of São Paulo. Hospital das Clínicas and Famerp are two of the 14 study centers accredited by the Butantan Institute - which develops the vaccine -, where the tests of the third stage of the project will be done. This phase will involve 17 thousand people in 13 cities in the five regions of the country. Next week, according to the institute, a center in Manaus (AM) and another in Boa Vista (RO) will also start work.

The last step of the research will be used to prove the effectiveness of the vaccine. Of the total number of volunteers, two thirds will receive the vaccine and one third will receive placebo, which is a substance with the same characteristics of the vaccine, but without the virus, that is, without effect. No one - neither the medical staff nor the volunteer - will know who will get the vaccine and who will get the placebo. The objective is to find out from the examination of the material collected from these volunteers, if the person who took the vaccine was protected and the person who took the placebo contracted the disease.

According to Jorge Kalil, director of the Butantan Institute, São José do Rio Preto is the only city without being a capital that will participate in this stage. "It is the only center that is not in a capital city. [São José do] Rio Preto has a very good medicine and is in a region where dengue is very strong. So it is a good place for people to test [the vaccine ], "said Kalil.

In São José do Rio Preto, the vaccination and follow-up of volunteers by Famerp are done in a Basic Health Unit. People who participate in the test are voluntary, healthy, dengue fever at some point in their lives and fall into three age groups: 2 to 6 years, 7 to 17 and 18 to 59. They are followed up by the medical team for a period of five years to check how long the protection offered by the vaccine

"This last step means that in the 14 centers we will vaccinate 17,000 people in three age groups.Let's start with the adults, then the teens and then the children.We will give the vaccine in a study called double-blind random variable, that is, neither the person nor does the recipient know if they are taking the vaccine or the placebo. Let's look at cases that will occur naturally from dengue. There is an observer committee who knows who has received one or other [placebo or vaccine], and who will observe, by statistical calculations, to see if the vaccine protects and by what percentage. "We can have the answer in a year, but we're going to keep track of these individuals for five years," said Kalil.

According to him, the last stage of testing could last for about a year. years because we want to know how they will behave in that period: whether they will still be protected against dengue fever and whether there will be a need for a booster dose in the future ?, he said.

The institute estimates that the vaccine will be available for registration until 2018. "There are 3 billion people in the world who are at risk of contracting dengue and there are more than 3 million cases of the disease in Brazil, with relatively high mortality," added the director. of the institute.

The vaccine

The dengue vaccine has the potential to protect against four disease viruses with a single dose. It is produced with live but genetically weakened viruses. With live viruses, the immune response is greater, but as they are attenuated, there is no potential to trigger the disease.In the previous stages, the vaccine was tested in 900 people: 600 in the first phase of clinical trials in the United States and 300 in the second stage, held in the city of São Paulo in partnership with the USP Medical School (through Hospital das Clínicas and Instituto da Criança) and the Instituto Adolfo Lutz.

According to Kalil, the other phases of the tests showed that the vaccine had behaved well. "If we take all cases of the other phases, when we look at the level of neutralizing antibodies produced, ie the number of antibodies that do not let the virus proliferate, we see that it induced a very strong response against the four serotypes.In addition to antibodies, the vaccine induces a cellular response, that is, the vaccine teaches T-lymphocytes to defend against the virus and this is a very important adjuvant of the antiviral response, "he commented.

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