Updated on 12 September 2012
The results of the clinical trial in Thailand have been published in the online publication of The Lancet
Singapore: Sanofi Pasteur, the vaccines division of Sanofi has published clinical study results of its dengue vaccine candidate in the online publication of The Lancet. The results of the trial conducted in Thailand show ability of the vaccine candidate to protect against dengue fever caused by three dengue virus types. The results of the efficacy study confirm the excellent safety profile of the vaccine candidate.
Dengue fever has emerged as one of the biggest challenges in the emerging economies of the world. In the Philippines, one of the Southeast Asian economies, the number of dengue cases have been reported to be at an all time high. According to data provided by the Philippines Department of Health recently to the media, the number of cases of the mosquito-borne viral infection stands at 80, 745 in the country. This study was conducted by Sanofi 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.
Sanofi is conducting large-scale phase III clinical studies with 31,000 children and adolescents in Latin America (Mexico, Colombia, Honduras, Puerto Rico and Brazil) and in Asia (the Philippines,
Vietnam, Malaysia, Indonesia, and Thailand).
"The complexity of dengue virus infection has hampered vaccine research for decades. This is the first time in 50 years of dengue research that I have seen a vaccine that protected a large group of children from clinical disease caused by dengue viruses. Best yet, the vaccine met the highest safety expectations," said Dr Scott Halstead, International Vaccine Institute, Seoul, Republic of Korea. "These results should be a source of hope for millions of parents whose children are at risk of severe dengue, a life-threatening disease which often requires hospitalization."
The full analysis of vaccine efficacy against each serotype, reflecting real-life conditions showed vaccine efficacy to be 61.2 percent against dengue virus type 1, 81.9 percent against type 3 and 90 percent against type 4. One of the dengue virus types (serotype 2) eluded the vaccine. Analyses are on to understand the lack of protection for serotype 2 in the particular epidemiological context of Thailand.