AsianScientist (Jul. 27, 2012) – Sanofi Pasteur, the vaccines division of Sanofi, announced on Thursday promising efficacy results of its dengue vaccine candidate in an efficacy trial conducted in Thailand.
The study was conducted in 4,002 children aged 4 to 11 years, in partnership with the Mahidol University under the patronage of the Thai Ministry of Public Health in Muang district of the Ratchaburi Province.
The tetravalent dengue vaccine candidate is a live attenuated vaccine, administered in a vaccination schedule of three doses given six months apart (at 0, 6, and 12 months).
Evidence of protection was demonstrated against three of the four virus serotypes circulating in Thailand. Analyses are ongoing to understand the lack of protection for the fourth serotype in the particular epidemiological context of Thailand.
Importantly, the results confirm the excellent safety profile of the vaccine candidate. The full data resulting from this first efficacy trial are currently under scientific review, and will be published later this year.
“Results of this first efficacy trial with Sanofi Pasteur’s dengue vaccine candidate represent a key milestone in the quest to develop a safe and efficacious human vaccine against dengue,” said Michel De Wilde, Ph.D., Executive Vice President, Research & Development, Sanofi Pasteur.
Past clinical studies (Phase I, II) in adults and children in the U.S., Asia, and Latin America demonstrated an immune response against all four serotypes after three doses of the vaccine. The vaccine was well tolerated with a similar safety profile after each dose.
Large scale phase III dengue vaccine clinical studies in 31,000 adults and children are ongoing in Latin America (Mexico, Colombia, Honduras, Puerto Rico, and Brazil) and in Asia (the Philippines, Vietnam, Malaysia, Indonesia, and Thailand).
The U.S. Food and Drug Administration (FDA) has granted fast-track designation to the company’s investigational dengue vaccine.
Dengue is a threat to nearly three billion people, especially in Latin America and Asia where epidemics occur. Of the estimated 230 million people infected annually, two million – mostly children – develop dengue hemorrhagic fever (DHF), a severe form of the disease.
Source: Sanofi Pasteur.
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