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news.Inviragen has initiated the first clinical trial of investigational dengue fever vaccine DENVax. The trial, to be conducted at Saint Louis University, is designed to assess the safety of the investigational dengue vaccine.
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Inviragen’s DENVax investigational vaccine, developed by researchers at the CDC’s division of Vector-Borne Diseases, 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 mixture of the three engineered viruses and the original DEN-2 strain. Inviragen completed preclinical testing, formulation, and manufacturing of the tetravalent DENVax vaccine to be used in the upcoming clinical trials.
For the clinical study, 72 healthy adult volunteers will receive injections of a placebo, a lower dose or a higher dose of the investigational vaccine. The vaccine will be administered in two doses, three months apart, either between the layers of the skin as an ‘intradermal’ shot or under the skin as a ‘subcutaneous’ injection.
In addition to the clinical trial in the US, Inviragen anticipates performing additional human clinical testing of DENVax in Colombia and Singapore.
Dan Stinchcomb, CEO of Inviragen, said: “Initiating this first clinical study of DENVax is an important milestone for Inviragen. The transition of this vaccine from the bench to the clinic is the culmination of many years of work by Inviragen, scientists at the Centers for Disease Control and Prevention (CDC) and our international collaborators.”
Jorge Osorio, chief scientific officer at Inviragen, said: “In animal model studies, DENVax is safe, induces neutralizing antibodies to all four dengue serotypes and protects against dengue infection. An Investigational New Drug application (IND) has been filed and reviewed by the FDA. We look forward to testing the safety and immunogenicity of the vaccine in the Phase 1 trial conducted at Saint Louis University.”
Sarah George, assistant professor in the division of infectious diseases at Saint Louis University and principal investigator of the study, said: “Finding a safe and effective vaccine for dengue is a global health priority. Approximately 3.6 billion people worldwide – more than half of the world’s population – now are at risk of contracting dengue disease.”