Medigen Vaccine Biologics Corp. (MVC) completed the phase II study for dengue vaccine in Taiwan and finished the clinical study report on April 8th. This bridging and proof-of-concept study assessed ethnic differences and evaluated the immunogenicity of the elderly population, which will be used as the evaluating basis for an indication expansion to the elder population.
The study design is a Phase II Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Immunogenicity and Safety of TetraVax-DV in Healthy Adults in Taiwan. This trial was executed in Taiwan and the total enrollment is 54 subjects.
The clinical trial shows great safety. According to the clinical study report, there were no vaccine-related SAEs observed in 54 subjects aged 20-70 years old. The immunogenicity data demonstrates that the vaccinated group produced higher neutralizing antibody titers (GMTs of PRNT50), and had a higher seropositivity rate and seropositivity rate against 4 types of Dengue virus than the controlled group. Moreover, the vaccinated group remained expressing neutralizing responses on the day 180 and the day 365 after vaccination, this result reveals that MVC's dengue vaccine shows immunogenicity not only within 20-50-year-old subjects but also in the elder group aged 51-70 years old.
MVC will plan another phase III clinical trial based on the results from NIH's clinical trials and this phase II study accordingly.