On September 28th MVC obtains TFDA's IND approval to conduct phase 2 POC clinical trial in Taiwan. Since the risk of dengue fever increases significantly in Taiwan's elderlies, this randomized, double-blind, placebo-controlled phase 2 clinical trial will include subjects up to 70 years old to verify vaccine's immunity and safety in senior population.
This dengue vaccine (TV003/TV005) was developed by Dr. Stephen Whitehead in US NIH, and confers 80%~100% protection to all 4 serotypes of dengue virus with just one dose, which is significantly more advantageous compared to other competitors' multiple-dose regime. NIH has conducted 10 phase 1 and phase 2 clinical trials in USA, Thailand and Bangladesh, including 3 human-challenge studies with encouraging data indicating vaccinated subjects are 100% protected from attenuated dengue infections.
MVC signed collaboration agreement with NIH in November 2016 and obtained market right in 17 countries. Earlier this month MVC further amended the agreement to expand territory up to 26 countries, covering 1/3 global population. While phase 2 POC clinical trial is ongoing, MVC will soon initiate a multi-regional, multi-central phase 3 clinical trial in Taiwan and South East Asia.