France - Sanofi Pasteur’s Dengue Vaccine Shows Proof Of Efficacy: Study

The results of the world’s first dengue vaccine efficacy study confirm the safety of Sanofi Pasteur’s dengue vaccine against 3 out of 4 dengue virus serotypes.

Sanofi Pasteur, the vaccines division of Sanofi, published in The Lancet on Tuesday clinical study data that confirm the safety of Sanofi Pasteur’s dengue vaccine against three out of four dengue virus serotypes.

The study was conducted in 4,002 Thai children aged 4 to 11 years, in partnership with Thailand’s Mahidol University.

Sanofi Pasteur’s dengue vaccine candidate is a live, attenuated vaccine, given as three doses six months apart (at 0, 6, and 12 months). The U.S. Food and Drug Administration (FDA) has granted fast-track designation to the dengue vaccine candidate.

The full analysis of vaccine efficacy against each serotype 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.

Large-scale Phase III clinical studies of the dengue vaccine candidate are underway with 31,000 children and adolescents in Latin America 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.

Dengue is a mosquito-borne disease caused by four dengue virus serotypes (1 to 4) and there is no specific treatment available for this disease. It is a threat to nearly three billion people and a health priority in many countries of Latin America and Asia where epidemics occur.

Of the estimated 220 million people infected annually, two million – mostly children – develop dengue hemorrhagic fever (DHF), a severe form of the disease. The World Health Organization has set the objective to reduce dengue morbidity by at least 25 percent and dengue mortality by 50 percent by 2020.

Source: Sanofi Pasteur

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