Dengue Fever Vaccine Trialled

Dengue fever is not a killer and compared to malaria, and as this mosquito-borne virus is hardly an international threat to health, it is unlikely to attract commercial attention from global pharmaceutical companies.

But when hot, humid conditions prevail over parts of Brazil, especially in Rio de Janeiro, much of the population can be debilitated by a disease that keeps on coming back. So clinical trials of a vaccine set for possible distribution in 2018 are something to celebrate – especially when the production is to take place in Brazil.

The Butantan Institute and São Paulo School of Medicine (FMUSP) announced on October 2 that they are recruiting volunteers for clinical trials of a dengue vaccine originally created by US researchers at the National Institutes of Health (NIH).

The Butantan Institute will be responsible for production of the vaccine, coordination of the clinical trials, and selection and training of researchers. In addition to USP and NIH, partners in the initiative include the Adolfo Lutz Institute, Johns Hopkins Bloomberg School of Public Health and Global Solutions For Infectious Diseases.

The trial vaccine will be effective against the four known types of dengue (1, 2, 3 and 4) and is composed of weak strains of live viruses. Previous tests have showed it can deliver immunity after a single dose.

Butantan Institute’s Alexander Precioso said “NIH made the vaccine available through a partnership with the Butantan Institute for production and human trials in Brazil. The vaccine will be tested for the first time in an endemic region where dengue is an extremely relevant public health concern.”

He said American research had shown mosquito carriers of dengue cannot transmit the disease from people immunized with the vaccine.

The first stage of the trials will have 50 participants who have never contracted dengue. The second phase set for 2014 will have another 250 volunteers, including some who have contracted dengue and some who have not.

If the study develops as planned, beginning in 2015 the vaccine will be tested in cities in different regions of Brazil, resulting in the volume of information required to request its registration  by 2018 with ANVISA, the Brazilian  drug safety agency.

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