Sanofi Pasteur: Dengue Vaccine Met Primary Endpoint in Phase III Study

Sanofi Pasteur’s dengue fever vaccine candidate showed a 56 percent reduced risk of disease compared to placebo in the first of two pivotal Phase III efficacy studies, the French drugmaker said Monday. The FDA granted the vaccine fast-track status in 2010.

A total of 10,275 healthy children ages 2 to 14, living in dengue-endemic areas of the Philippines, Vietnam, Indonesia, Malaysia and Thailand, were evaluated for symptomatic, virologically confirmed cases caused by any serotype for 28 days after receiving their one-year dose of the vaccine. Previous doses were administered at the start of the study and then at six months, with long-term follow-up ongoing, according to the company.

The second pivotal Phase III study is underway in healthy children ages 9 to 16 in Honduras, Brazil, Colombia, Mexico and Puerto Rico, with results expected in the third quarter. 

The World Health Organization estimates between 50 and 100 million dengue infections occur every year in more than 100 countries across Africa, the Americas, the Eastern Mediterranean, Southeast Asia and the Western Pacific. Currently, there is no vaccine and no treatment for the disease other than continued hydration.

Sanofi Pasteur is in the process of constructing a vaccine production center to provide speedier access once its vaccine gets licensed, which spokesman Benoit Rungeard says could be as early as next year.

According to the Dengue Vaccine Initiative, Merck, Takeda’s Inviragen and GlaxoSmithKline are working on dengue vaccines, as are Indian drugmakers Panacea Biotech and Bioloical E, Brazil’s Instituto Butantan, the National Institutes of Health and Vietnam’s Vabiotech and the Naval Medical Research Center, though none has yet made it to Phase III. — Lena Freund

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