Sanofi Pasteur has said that its work on a dengue vaccine, in the first of two pivotal phase-three efficacy studies, has achieved a "primary clinical endpoint".
The France-based company said this week the efficacy study showed a significant reduction in 56 per cent of dengue disease cases, with initial safety data consistent with the good safety profile observed in previous studies.
“Full analysis of the data will be undertaken in the coming weeks and reviewed by external experts prior to disclosure at an upcoming interna?tional scientific congress and publica?tion in a peer-reviewed journal later this year,” it said.
Dengue is a threat to nearly half the world’s population and a major public health priority in many countries in Asia and Latin America, where epi?demics occur.
“This achievement is the result of more than 20 years of work in the field of dengue, collaborating with investi?gators, volunteers, authorities, scien?tific experts and international organ?isations,” Olivier Charmeil, president and chief executive of Sanofi Pasteur, said.
“Developing a dengue vaccine for the benefit of children and their par?ents is at the heart of our mission. Our goal is to make dengue the next vac?cine-preventable disease and to sup?port the WHO [World Health Organisation]’s ambition to reduce dengue mortality by 50 per cent and morbidity by 25 per cent by 2020.”
Dr Maria Rosario Capeding, prin?cipal investigator at the Research Institute for Tropical Medicine in the Philippines, said it was the first time a dengue vaccine had successfully com?pleted a phase-three efficacy study.
“These significant clinical results, associated with the good safety profile of the vaccine, bring real hope to more than 100 million people affected each year by dengue, a disease without any specific treatment today,” she said.
The results of this first, large-scale efficacy study will be further complemented by results in the third quarter from a second, large-scale study now being conducted in Latin America, including more than 20,000 volunteers from Brazil, Colombia, Honduras, Mexico and Puerto Rico, the company said.