Tests for Brazilian dengue fever vaccine to begin in October

Criado em 26/09/13 13h25 e atualizado em 26/09/13 13h28
Por Fernanda Cruz Edição:s Fonte:Agência Brasil

São Paulo – A new vaccine against the dengue fever will be tested on humans in Brazil. The tests will begin in October as a partnership between the Butantan Institute and the University of São Paulo (USP). The vaccine is being developed to prevent the four known types of the disease with a single dose. According to Alexander Precioso, chief of clinical trials at Butantan, no other country has developed a similar vaccine.

Research began in 2006 in collaboration with US national health institutes. The virus samples were identified in the United States and later handed over to Butantan in 2010.

The vaccine uses an attenuated form of the virus. “This means that we modify the dengue virus itself to make people produce antibodies without developing the disease,” Precioso explained.

So far, more than 600 volunteers have been tested with the vaccine in the US. “Studies [in the US] verified that the vaccine is safe and can make people produce antibodies against the four virus types,” Precioso said. He went on to explain that no significant side effects have been reported, except for aching and redness on the puncture site – a typical vaccine symptom.

Since the dengue fever is not endemic in the US, none of the subjects had experienced the disease in the past. Conversely, in Brazil, tests will include former dengue patients. But the researcher reassured that, based on studies published in Southeast Asia and the US, patients with a history of dengue may be immunized free of hazards. “In the earliest days of the vaccine development [in the US], some subjects were administered monovalent vaccine (for a single type of virus) first, and subsequently immunized with a dose for a different virus form, in order to establish the risk for people who had had dengue in the past,” he explained.

In the early tests in Brazil, which will begin in the upcoming week, researchers will recruit 50 healthy male and female volunteers with a negative track record of dengue, aged between 18 and 59, in São Paulo only. They will be administered two doses, with a six-month gap between them.

The next stage will include subjects who have had history in the past, and a single dose of the vaccine will be administered. At this phase, 250 volunteers from São Paulo and Ribeirão Preto will be vaccinated.

For the third, final phase, people from all across the country and at various ages can volunteer. “This should produce the results we need to file a registration application with Anvisa [the Health Inspection Agency]. From that point, the vaccine will be ready to be made available,” Precioso concluded. Researchers expect the vaccine to be rolled out within five years.

Editors: Graça Adjuto / Olga Bardawil
Translator: Mayra Borges

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