Phase III trials (#Clinicaltrial) for Sinovac Biotech Ltd.'s inactivated EV71 vaccine (#Vaccine) have begun. Sinovac Biotech is a Chinese biopharmaceuticals company, and its EV71 vaccine would be helpful against hand, foot and mouth disease (HMFD).
Phase II trials for the same completed in Nov'2011, with confirmed results regarding safety and tolerance profiles of the vaccine. The tests also showed good immunogenicity. According to the results of phase II clinical trial, the formulation of 400U with aluminum adjuvant was selected to be used in phase III clinical trial to evaluate the efficacy of Sinovac's EV71 vaccine in protecting against HFMD.
The company expects an enrollment of up to 10,000 healthy volunteers between the age of 6 and 35 months for its Phase III trials. The Phase III trials are designed as a randomized, double blinded, placebo controlled study. The vaccination procedure comprises of two shots to be given to the volunteer at 0 and 28 days. These trials are anticipated to end in the first half of 2013.
Sinovac's focus on EV71 vaccine is clear with the development of a dedicated manufacturing facility for this vaccine. Sinovac aims to complete the construction and to obtain a GMP certificate in 2013.
Enterovirus 71, or EV 71, causes HFMD. More than 90 percent of the reported cases occur in children under five years old and it is a common and usually mild childhood disease. In recent years, however, there has been an increase in severe HFMD cases reported associated with neurological symptoms caused by EV 71 in parts of Asia, including mainland China, Hong Kong, Singapore, South Korea, and Taiwan. No vaccine or specific treatment is currently available to protect against this disease.
Christopher Fang, Worldwide Director, Clinical Research & Medical affairs, DePuy Spine, Johnson & Johnson, USA, will be presenting at Pharma Trials World Asia 2012 this March on "Utilising clinical technology to accelerate your trial progress."