Sanofi Pasteur's dengue vaccine enters phase III trial in Australia

Nov 8 2010

Sanofi Pasteur, the vaccines division of the pharmaceutical group Sanofi-Aventis, on Thursday announced the company had begun testing its dengue fever vaccine in a Phase III clinical trial in Australia, Dow Jones/Wall Street Journal reports. "Sanofi-Aventis already performed earlier clinical tests on children and adults with the vaccine in the U.S., Asia and Latin America," Dow Jones/Wall Street Journal adds (Landauro, 11/4).

"This study is part of a global phase 3 clinical study program aimed at advancing the development of a novel vaccine for the prevention of dengue disease in children and adults," according to a Sanofi Pasteur press release. "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 release states.

It continues: "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 authorization by regulatory authorities" (11/4).

"We are now entering the final laps of a long run that Sanofi Pasteur started almost 20 years ago," said Wayne Pisano, president and chief executive of the company. He added that if the vaccine is successful, the company plans to introduce it in countries where dengue is a significant public health priority, PharmaTimes writes (McKee, 11/4).

IRIN, Scientific American Examines Scientific Efforts Against Dengue, Malaria

IRIN examines scientists' desire to release genetically-modified (GM) mosquitoes into the wild in an effort to help prevent the spread of dengue. Although "[t]hese mosquitoes are engineered with an extra gene or inserted bacterium or have had a gene altered so that either their offspring are sterile and unable to spread dengue, or simply die," the news service writes that some people are concerned over possible unforeseen ramifications the release of such genetically-modified insects could present. "For half a century, scientists have released billions of engineered insects - for example, fruit flies  to save plants, but to date there has not been a field release of insects engineered to save humans," IRIN writes.

The article describes the decision by the NGO Pesticide Action Network-Asia and the Pacific to "oppose a since-granted request to release modified mosquitoes [in Malaysia] on the grounds that 'it may have environmental or health consequences as well as carry risks arising from horizontal gene transfer,'" as was described by Executive Director Sarojeni Rengam, according to the news service. The piece also includes comments by Imperial College London Professor John Mumford, who is also a lead researcher on the "WHO-funded regulatory group Mosqguide, founded to develop best practices for deploying genetically modified mosquitoes to fight mosquito-borne diseases, primarily dengue and malaria," IRIN writes (11/3).

In related news, Scientific American explores recent efforts to develop a vaccine that protects against malaria: "Scientists have many promising malaria vaccine candidates in the works, and for the first time one [RTS,S] has reached advanced human trials. If it or another candidate is even partly effective in people, it could save the lives of millions of children and pregnant women. It would be the only vaccine yet developed against a human parasite, an achievement of Nobel caliber. And it could, in its first-generation form, be distributed in Africa as soon as 2015."

Regarding the ongoing trial of RTS,S, Scientific American writes that its "impact could be enormous, saving hundreds of thousands of lives every year - provided that the vaccine is widely distributed." The article references several "hurdles" that will remain to be overcome even if the vaccine proves effective in the larger trial.

The article also examines the challenges that have complicated malaria vaccine development in the past, how development efforts have evolved over time and several current strategies scientists are using to approach vaccine development today, as described by several scientists involved in such work (Carmichael, November 2010).