A FIRST IN DENGUE VACCINE STUDY
DENGUE is a threat to nearly half the world’s population. It continues to be a major public health concern in Malaysia, a century after its first reported outbreak in 1902.
According to the World Health Organization, between 2004 and 2010, Malaysia reported the 10th highest number of dengue cases among the 30 most highly endemic countries/ territories.
Currently, there is no specific treatment available for dengue. Sanofi Pasteur, the vaccines division of Sanofi, recently announced that the first of two pivotal Phase III efficacy studies with its dengue vaccine candidate has achieved its primary clinical endpoint. The efficacy study showed a significant reduction of 56 per cent of dengue disease cases.
Initial safety data are consistent with the good safety profile observed in previous studies. Full analysis of the data will be undertaken and reviewed by external experts prior to disclosure at an upcoming international scientific congress and publication later this year.
“This achievement is the result of more than 20 years of work in the field of dengue,” said Olivier Charmeil, President and CEO of Sanofi Pasteur. “Our goal is to make dengue the next vaccine-preventable disease and to support the WHO’s ambition to reduce dengue mortality by 50 per cent and morbidity by 25 per cent by 2020.”
“This is the first time ever a dengue vaccine successfully completed a Phase III efficacy study,” said Dr Capeding, principal investigator, Research Institute for Tropical Medicine, the Philippines.
The results of this first, large-scale efficacy study will be further complemented by results later this year from a second, large-scale study currently conducted in Latin America, involving more than 20,000 volunteers from Brazil, Colombia, Honduras, Mexico and Puerto Rico.
The Phase III clinical study conducted in Asia is a randomised, observer-blind, placebo-controlled multicentre trial.
A total of 10,275 children aged 2 to 14 from dengue endemic areas of Indonesia, Malaysia, the Philippines, Thailand and Vietnam participated in the study from 2011-2013. The study will continue with a long-term follow up of the population.
