Inviragen have announced that the dengue vaccine DENVax has shown promise in trials and has advanced into the second stage of an ongoing phase II, randomized, double-blind, placebo-controlled trial being conducted in Puerto Rico, Colombia, Thailand and Singapore.
"The completion of the first stage of this Phase 2 study is an important milestone for Inviragen, as it represents the first comprehensive safety evaluation of the vaccine in individuals of various ages who live in dengue endemic areas," said Dr. Dan Stinchcomb, CEO of Inviragen. "The DSMB determined that the first dose of the vaccine is well tolerated in adults, adolescents and children, some of whom were pre-exposed to dengue viruses."
The dengue viruses are endemic throughout the world’s subtropical and tropical regions, threatening over 3.6 billion people. The disease is caused by one of four different RNA viruses: serotypes DEN-1, DEN-2, DEN-3, DEN-4.
A very exciting aspect of DENVax is that it is designed to protect against all four serotypes of the dengue virus. Last year, trials showed that a dengue vaccine produced by Sanofi was effective against three serotypes, but showed a lack of efficacy against the aggressive DEN-2 (read about â3 recent vaccine trials with disappointing results'). Because DENVax is engineered with a DEN-2 backbone rather than a yellow fever backbone, DENVax has the potential to neutralise all four of the dengue viruses.
The Phase 2 study has evaluated the safety and immunogenicity of two doses of DENVax, administered three months apart, in approximately 150 individuals. Following an assessment of this preliminary data by an independent monitoring board, the study will now move into a second stage where it will enroll approximately 200 children aged 18 months to 11 years.
Inviragen hope to have the vaccine approved and on the market by 2017.
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If you'd like to know more about research and development in vaccines, including vaccines against dengue fever, you might like to consider attending the World Vaccine Congress and Expo 2013 on the 16-18 April 2013, Gaylord National Hotel and Convention Center, Washington DC. You can download the brochure here.