China-based biopharmaceutical company, Sinovac Biotech Ltd., announced preliminary top-line data from its Phase III clinical trial for it's proprietary Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD), according to a company press release Mar. 14.
The study tested the vaccine candidate's efficacy, immunogenicity and safety. In testing the vaccine's efficacy, researchers evaluated the vaccine to prevent HFMD caused by EV71 in infants of six to 35 months old. Preliminary data from the study reveals the vaccine was greater than 95 percent successful against the disease.
In addition, the vaccine showed good immunogenicity and safety. Serious adverse events were seen in slightly more than two percent of vaccine recipients.
The trial was conducted at three sites across China's Jiangsu province and 10,000 healthy infants completed the two-dose vaccination schedule.
Chief executive Weidong Yin said the conclusion of this trial marks "an important milestone" in the development of the vaccine. He added that HFMD "continues to represent a significant unmet public health need and economic burden in China, as well as several other Asian countries".
HFMD is typically a benign and self-limiting disease. Most common in young children, it presents as fever, oral lesions and rash on the hands, feet and buttocks. The oral lesions consist of rapidly-ulcerating vesicles on the buccal mucosa, tongue, palate and gums. The rash consists of papulovesicular lesions on the palms, fingers and soles, which generally persist for seven to 10 days, and maculopapular lesions on the buttocks.
EV-71 has been implicated in HFMD outbreaks in Southeast Asia over the past several years. EV-71 is a non-polio enterovirus.
Complications associated with HFMD caused by the more pathogenic EV-71 strain include encephalitis, aseptic meningitis, acute flaccid paralysis, pulmonary edema or hemorrhage and myocarditis. Most deaths in HFMD occur as a result of pulmonary edema or hemorrhage.
In 2013, Japan, Macau, South Korea and Singapore are reporting high numbers of new HFMD patients.
More than 10,000 have been infected in Vietnam so far this year. Health officials expect an estimated 100,000 patients this year.
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