Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and SNY), announced today the expansion of its dengue vaccine clinical program in Latin America with a new multicenter study in children and adolescent in Mexico, Colombia, Honduras and Puerto Rico. This new multicenter study complements an earlier study in Mexico and an ongoing study in Peru.
These studies are aimed at advancing the development of a novel vaccine for the prevention of dengue infections in Latin America. Currently, there is no specific treatment available against dengue fever, which is the most widespread tropical disease after malaria.
"Latin America was considered almost free of dengue in the 1960s. Since then, urbanization and travel have contributed to the fast re-emergence of the disease. Today, dengue disease is a severe public health issue throughout Latin America," said Dr. Roberto Tapia-Conyer, Director General at Carso Health Institute. "So far, controlling the mosquitoes that transmit dengue didn't stop this trend. A safe and effective vaccine would be most welcome to prevent dengue epidemics in the region."
Dengue in Latin America: a growing burden
Nineteen Latin American countries were certified as dengue free between 1952 and 1965. The first reappearance of dengue fever was recorded in 1968, and by 2007 the disease had once more taken hold in all those countries [1]. In 2008 and 2009, severe dengue epidemics have been reported in Mexico, Paraguay, Brazil, Bolivia and Argentina. Many factors have contributed to the re-emergence and dramatic increase in dengue fever including urbanization and increased travel which facilitates dissemination of dengue viruses and the circulation of all four dengue serotypes in the region.
"Fighting dengue is of the utmost public health importance: We must remain on epidemiological alert as dengue continues to circulate in Latin America", said Dr. Jorge Mendez, Investigator at the children's hospital Federico Gomez in Mexico and co-investigator for the evaluation of a dengue vaccine in Mexico. "Clinical studies in Mexico are critical steps to advance the development of a vaccine for the prevention of dengue. We are happy that Mexico contributes to scientific research that would benefit the entire region."
"Most of the severe dengue cases are among children under the age of 15 years old. It is an important cause of hospitalization which contributes highly to the burden of disease and increases costs for our health system," said Dr. Diana Patricia Rojas Alvarez, Expert for vector born diseases, dengue and yellow fever, at the National Institute of Health in Colombia. "A safe and effective vaccine for children is much needed and we are pleased to support pediatric clinical studies in Colombia."
Sanofi Pasteur global clinical study program for a dengue vaccine
Sanofi Pasteur started the development of a dengue vaccine in the '90s. Clinical studies with its most advanced tetravalent candidate vaccine started in the 2000s. Sanofi Pasteur's dengue vaccine candidate has been evaluated in clinical trials (Phase I, II) in adults and children from non-endemic (U.S.) and endemic countries (Mexico, Philippines). Overall, a balanced immune response against all four serotypes was observed after three doses of the vaccine. The vaccine appears to be well tolerated with a similar safety profile after each dose [2].
Sanofi Pasteur's dengue vaccine research program includes ongoing clinical studies with adults and children in Mexico, Colombia, Honduras, Puerto Rico, Peru, the Philippines, Vietnam, Singapore, and Thailand. These studies follow the highest standards from the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Sanofi Pasteur's tetravalent dengue vaccine is the leading dengue candidate vaccine in development [3,4].
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