Sanofi Pasteur dengue vaccine cuts cases by 56%, study shows

MANILA, Philippines - Sanofi Pasteur yesterday announced that the first of two pivotal Phase III efficacy studies with its dengue vaccine candidate was successful.

In a statement, Sanofi Pasteur, the vaccines division of pharmaceutical giant Sanofi, said the “efficacy study showed a significant reduction of 56 percent of dengue disease cases.”

“This achievement is the result of more than 20 years of work in the field of dengue, collaborating with investigators, volunteers, authorities, scientific experts and international organizations,” said Sanofi Pasteur president and chief executive officer Olivier Charmeil.

He said developing a dengue vaccine “for the benefit of children and their parents is at the heart of our mission.”

“Our goal is to make dengue the next vaccine-preventable disease and to support the WHO’s ambition to reduce dengue mortality by 50 percent and morbidity by 25 percent by 2020,” he added.

Sanofi Pasteur said the initial safety data are 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 international scientific congress and publication in a peer-reviewed journal later this year.

Sanofi Pasteur said the annual incidence rate of 4.7 percent observed in the control group demonstrates the “very high burden of disease in Asia.”

According to Ma. Rosario Capeding, principal investigator from the Research Institute for Tropical Medicine-Philippines, it was “the first time ever a dengue vaccine successfully completed a Phase III 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 will be further complemented by findings in the third quarter from a second, large-scale study currently being conducted in Latin America, including more than 20,000 volunteers from Brazil, Colombia, Honduras, Mexico and Puerto Rico.

Sanofi Pasteur said the Phase III clinical study conducted in Asia is a “randomized, observer-blind, placebo-controlled multicenter trial.”

A total of 10,275 children aged two to 14 from dengue endemic areas of Indonesia, Malaysia, the Philippines, Thailand and Vietnam participated in the study from 2011 to 2013 and were randomized to either receive three injections of the dengue vaccine or a placebo (2 to 1 ratio) at six-month intervals.

The primary endpoint was measured by the number of symptomatic virologically confirmed dengue cases caused by any serotype.

Sanofi Pasteur said the study will continue with a long-term follow-up of the population.