Sinovac Biotech has announced the positive Phase I clinical data of its inactivated Enterovirus 71 (EV71) vaccine, indicated for the prevention of hand, foot and mouth disease (HFMD).
In the Phase I clinical trial, EV71 vaccine candidates were given to adults first, starting from the lowest dosage to higher dosages. The trial found the vaccine was well tolerated and the testing results on neutralising antibody showed improved immunogenicity.
The study data has also been confirmed in the Phase II trial, which also reported that the EV71 vaccine showed better immunogenicity and a favourable safety profile with no vaccine-related serious adverse events.
Sinovac Biotech chairman president and CEO Weidong Yin said that in January the company had begun Phase III clinical trials before the HFMD outbreak season.
"Through the end of March 2012, approximately 10,000 healthy volunteers have been enrolled, and the two-shot inoculation schedule, at 0 and 28 days, and the blood collection on the 56th day after the first inoculation have been completed in these volunteers," Yin added.
"Currently, the Phase III trial is progressing on schedule and is on track to be completed in the first half of 2013."
Li Yan-Ping of the Center for Disease Control and Prevention of the Guangxi Zhuang Autonomous Region and principle investigator of the study said the human EV71 inactivated vaccine was well tolerated in the healthy volunteers.
"For immune response, we observed that the seropositive rates of neutralising antibody increased to 100% for all dosage groups after the second vaccination," Yan-Ping added.
According to the Chinese Ministry of Health, for the period of 1 January to 30 November 2010, the disease caused 876 deaths in China and over 1.73 million HFMD infection cases compared to 353 fatalities in China and over 1.15 million HFMD infectious in 2009.
Sinovac Biotech is a China-based biopharmaceutical company focused on the research, development, manufacturing and commercialisation of vaccines that protect against human infectious diseases.