Sanofi Pasteur, the vaccines division of sanofi-aventis Group has said that its dengue vaccine has entered phase 3 clinical trials in Australia, making it the most clinically advanced dengue vaccine. This is the final stage of testing in dengue vaccine development programme that started nearly 20 years ago.
This study is part of a global phase 3 clinical study programme aimed at advancing the development of a novel vaccine for the prevention of dengue disease in children and adults. Currently, there is no specific treatment available for dengue fever, which is a threat to nearly three billion people and a public health priority in many countries of Latin America and Asia where epidemics occur.
The study in Australia is the first to use dengue vaccine doses produced with industrial scale processes. The study is aimed at demonstrating that production of the vaccine at industrial scale will meet consistency criteria required for market authorisation by regulatory authorities.
“To address the global health challenge represented by dengue fever, we are conducting an unprecedented dengue vaccine research and development programme as well as a scale up of the vaccine production,” said Wayne Pisano, president and chief executive officer of Sanofi Pasteur. “We are now entering the final laps of a long run that Sanofi Pasteur started almost 20 years ago. If successful, we are committed to introducing the vaccine in countries where dengue is of highest public health priority.”
Sanofi Pasteur's candidate dengue vaccine-which targets all four virus serotypes-has been evaluated in clinical studies (Phase 1, 2) in adults and children in the U.S., Asia and Latin America. Overall, a balanced immune response against all four serotypes was observed after three doses of the vaccine. The vaccine is well tolerated with a similar safety profile after each dose.
Clinical studies in adults and children are ongoing in Mexico, Colombia, Honduras, Puerto Rico, Peru, the Philippines, Vietnam, Singapore, Australia, and Thailand.
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