Hyderabad: In a major development that could address dengue fatalities and outbreaks in India, the severe stress that the ailment puts on public healthcare institutions and productivity of individuals, an experimental drug has proved to be 80 per cent effective in preventing dengue infection among young patients in countries were dengue is endemic.
The preliminary results of a large phase-3 clinical trials carried out in Asia and Latin American countries, titled Tetravalent Immunisation against Dengue Efficacy Study (TIDES) of dengue vaccine TAK-03, were published in New England Journal of Medicine (NEJM) on Wednesday.
Being developed by Takeda Pharmaceuticals, the clinical trials were carried out among 20,000 children aged between 4 years and 16 years. According to the study, the vaccine efficacy (VE) was 80.2 per cent in the 12-month period after the second dose, which was administered three months after the first dose. Similar degrees of protection was seen in individuals who had not been previously infected with dengue.
The dengue vaccine candidate was generally well-tolerated, and no important safety risks were observed to date, researchers said. “The results of this first analysis are very encouraging, indicating that the vaccine could potentially provide important public health benefits against dengue fever and hospitalisation,” said Humberto Reynales, lead author of the NEJM paper.
The researcher said the vaccine would be important to further analyse the trial results over time to assess the long-term efficacy and safety of the vaccine. “If longer follow-up data confirm this initial observation, we are looking at a significant step forward in the global fight against dengue,” he said.
A highly successful dengue vaccine will be a boost for patients because dengue represents a big public health threat not only in Telangana but also across India. “It is critical that we have access to a safe and effective vaccine candidate that can reduce the devastating impact dengue fever has in endemic regions,” In-Kyu Yoon, Senior Advisor, International Vaccine Institute, said in a statement.
The president of Global Vaccine business unit of Takeda, Rajeeva Venkayya said the vaccine was tested on children who had never been exposed to dengue. “The data has evaluated the performance of our dengue vaccine candidate in a diverse set of countries across Asia and Latin America, and in a study population that intentionally includes a large proportion of children who had never been exposed to dengue,” he said.
According to Takeda officials, the findings strongly suggest that the vaccine could help address the massive global burden of dengue in all populations.