French drugmaker Sanofi's (SNY, SNYNF) vaccines division Sanofi Pasteur late Monday announced the online publication of clinical study results showing that its vaccine candidate protects against dengue fever caused by three dengue virus types.
The results of the world's first efficacy study confirm the safety profile of the dengue vaccine candidate, the firm said. The study results have been published in The Lancet.
Dengue is a mosquito-borne disease caused by four dengue virus serotypes. It is a threat to nearly 3 billion people, especially in some countries of Latin America and Asia.
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. Sanofi said analyses are in progress to understand the lack of protection for serotype 2 in the particular epidemiological context of 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.
Sanofi Pasteur's dengue vaccine candidate is a live, attenuated vaccine. The vaccination schedule is 3 doses given 6 months apart at 0, 6 and 12 months.
Dr. Scott Halstead, International Vaccine Institute, Seoul, Republic of Korea, said, ''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."
Large-scale phase III clinical studies of the dengue vaccine candidate are underway with 31,000 children and adolescents in 10 countries in Asia and Latin 2/3 America. These studies are expected to generate additional data in a broader population and in several epidemiological settings.
Sanofi closed in Paris on Monday lower by 0.65 percent at 65.72 euros on 2.01 million shares.
by RTT Staff Writer
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