Sanofi's Dengue Vaccine Meets Phase 3 Trial Endpoint

Sanofi vaccines division Sanofi Pasteur announced that the first of its two pivotal Phase III studies evaluating the efficacy of the company’s dengue vaccine candidate has met its primary clinical endpoint.

“This is the first time ever a dengue vaccine successfully completed a Phase 3 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,” said Dr. Capeding, principal investigator at Research Institute for Tropical Medicine in the Philippines.

The efficacy study reduced 56 percent of dengue diseases. Data from the first, large-scale study will be supported by results from a second, large-scale study in the third quarter of 2014. The company said the study will involve over 20,000 volunteers from Latin America.

Dengue continues to threaten nearly half the world population. Dengue hemorrhagic fever is a potentially lethal complication characterized by fever, vomiting, abdominal pain, and breathing difficulty. The disease is a high public health priority in many Asian and Latin American countries. There is currently no vaccine, nor are there specific treatments for dengue.

Olivier Charmeil, president and CEO of Sanofi Pasteur, said, “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… 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.”

The company said it will conduct a review of the dengue drug candidate’s data in the next few weeks before presenting results at an upcoming international scientific congress. Results of the trial will also be published in a peer-reviewed journal later this year.