Inviragen is developing a vaccine for Hand Foot and Mouth disease that is caused by the picorna virus, EV71, mostly in Asia. Virus can cross blood-brain barrier and can cause serious disease with meningitis, encephalitis also, cardiac disease. Children 1-5 years old are mostly affected. There is no vaccine or therapy for this disease.
The vaccine consists of EV71 inactivated whole viral particle, grown on Vero cells and formulated with Alum and is given in two doses one month apart. Phase 1 study was completed on a total of 36 healthy adults, in Singapore last year. The safety and tolerability of the vaccine was very good with very mild adverse events in less than 25% of subjects. Immunogenicity data: 100% seroconversion at both doses. Will initiate Phase 2 study on approximately 300 subjects later this year. Phase 3 will be done on around 2000 subjects.