An experimental vaccine prevented young children from being infected by a virus that caused 2,000 deaths from hand, foot and mouth disease in the past decade, according to a late-stage clinical trial.
The shot provided “significant protection” against disease associated with enterovirus 71, known as EV71, especially hand, foot and mouth disease in children under the age of three, according to the study by Chinese scientists published online in the Lancet today.
The vaccine candidate is one of two in the final stage of clinical trials for use against a virus also associated with more severe diseases, such as aseptic meningitis and encephalitis, in children younger than age five. The experimental shot doesn’t protect against hand, foot and mouth disease originating from coxsackievirus A16, which the World Health Organization says is the most common cause.
“This multicenter randomized controlled trial done in China is a notable advance in protection against EV71,” Nigel Crawford and Steve Graham, pediatricians at the Murdoch Childrens Research Institute in Melbourne, wrote in an accompanying commentary. “The major effect of this vaccine will be to reduce hospital admissions.”
Symptoms of hand, foot and mouth disease, or HFMD, include fever, blister-like sores in the mouth, and a skin rash, according to the Atlanta-based U.S. Centers for Disease Control and Prevention.
The researchers, led by Zhu Fengcai of the Jiangsu Provincial Center for Disease Control and Prevention, tested more than 10,000 healthy children between 6 months and 35 months old at four sites in China. Participants were randomly assigned to get two doses of placebo or vaccine over four weeks, and were tracked for a year starting March 2012.
Among those who received the vaccine, 90 percent were protected against HFMD linked to EV71, and 80.4 percent against EV71-associated disease, including neurological complications, for at least a year.
The scientists found no evidence that the vaccine provided protection against coxsackievirus A16.
“Despite its high efficacy for preventing EV71-associated HFMD, the EV71 vaccine might have little part in reducing the overall incidence of HFMD, even by universal mass immunization of children,” the researchers wrote.
EV71 has been associated with serious complications and may be fatal, while HFMD caused by coxsackievirus A16 usually results in a mild disease, according to the Geneva-based WHO.
Encephalitis and meningitis are potentially fatal conditions in which the brain or its lining become inflamed.
The research was funded by China’s 12–5 National Major Infectious Disease Program and Beijing Vigoo Biological, a unit of China National Biotec Group. The group is part of Sinopharm Group Co. (1099), China’s biggest drug distributor.
Zhu, the study’s lead scientist, presented the results of another EV71 vaccine being tested by Sinovac Biotech Ltd. (SVA) at the 13th Annual World Vaccine Congress & Expo in Washington D.C. last month, the company said. That vaccine has also undergone phase-three testing, according to the Sinovac announcement.
Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, added an early-phase EV71 vaccine candidate to its pipeline this month with an agreement to acquire Inviragen Inc.
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