AsianScientist (Feb. 28, 2013) – Inviragen, Inc. today announced the initiation of the second stage of an ongoing Phase II, randomized, double-blind, placebo-controlled study of DENVax™, its investigational dengue vaccine.
The Phase II study is enrolling individuals in Puerto Rico, Colombia, Singapore, and Thailand.
In the first stage of the trial, an independent data and safety monitoring board (DSMB) evaluated the safety and immunogenicity of two doses of DENVax, administered three months apart. Approximately 150 individuals were enrolled in this first stage in four different age groups.
In this second stage, DENVax will be tested for safety and immunogenicity in approximately 200 additional children aged 18 months to 11 years.
“The completion of the first stage of this Phase II 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.”
Inviragen’s DENVax vaccine is based on an attenuated DEN-2 virus that generates long-lasting anti-dengue immune responses. CDC scientists engineered this clinically tested, weakened DEN-2 virus to express DEN-1, DEN-3 or DEN-4 structural genes. DENVax is a four-way (tetravalent) mixture of the three engineered viruses as well as the original DEN-2 strain.
More than 3.6 billion people live in countries that have frequent dengue outbreaks. The four dengue viruses are spread by the mosquito, Aedes aegypti, which is found throughout tropical and subtropical regions. According to the Dengue Vaccine Initiative, dengue viruses cause an estimated 30 to 50 million cases of debilitating dengue fever and 2.1 million cases of severe dengue disease leading to over 20,000 deaths every year.
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Source: Inviragen Inc.
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