Pharmacology




Dengue vaccine enters phase 3 clinical trials

 

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.

References:

1. Saville et al, Clinical development of a tetravalent dengue vaccine for endemic areas, ICID Miami, March 2010; Lang et al, Toward a tetravalent dengue vaccine in Brazil, Tropical Medicine meeting, Iguacu Falls, March 2010 
 

Dengue fever

Dengue fever is a mosquito-borne disease caused by four dengue virus serotypes (1 to 4). Overall, the disease is a potential threat to almost half of the world's population. Of the estimated 220 million people infected annually, two million-mostly childrendevelop dengue hemorrhagic fever (DHF), a severe form of the disease.

DHF is a leading cause of hospitalization, placing tremendous pressure on strained medical resources and having a heavy economic and societal impact. 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 virus serotypes.

For continuous up to date information about dengue fever outbreaks, visit www.denguewatch.org, a news hub reporting worldwide alerts on dengue, provided by the Pediatric Dengue Vaccine Initiative.



 D
ate of upload: 17th Feb 2011

 

                                  
                                               Copyright © 2011 MiddleEastHealthMag.com. All Rights Reserved.