Hand, foot and mouth disease (HFMD) has become a serious childhood disease in Asia. The disease has a viral origin. The virus that is associated to the most severe form of HFMD is the enterovirus 71 (EV71). In most cases, infection does not cause symptoms or only leads to rash and speckles around the mouth, hands and feet, but the infection may occasionally spread and cause other symptoms as well, such as meningitis and airway infection. In 2008, out of 490,000 reported infections in China, 126 children died after being infected by this virus.
Whereas EV71 may be most dangerous virus among those that lead to HFMD, there are other viruses as well that cause the disease and lead to serious and critical symptoms. It is therefore not surprising that the disease is battled from multiple directions. Governments, schools, companies, hospitals and researchers are all trying to limit the damage caused by HFMD by imposing hygiene and school-closing programs, developments of vaccines and drugs for treatment.
This year, a large Chinese consortium, indeed consisting of a number of health centers and universities, either national or from Jiangsu, Beijing, Xi’an, and Sinovac, a vaccination developer from Beijing, successfully completed the phase 3 clinical trial for a vaccination against EV71. Over 10,000 children between 6 and 35 months of age received two doses of a vaccine, or placebo, and were followed for 12 months. The vaccinated children were 7 times less likely to develop EV71-cuased HFMD; also, while EV71 infections lead to 24 hospitalizations in the placebo group during this period, none of the vaccinated children were hospitalised. Altogether, the vaccine was reported to be safe and effective for one year. The consortium will continue to develop this vaccine, in order to maximize its efficacy for a longer period of time.
This study was published in the New England Journal of Medicine (DOI: 10.1056/NEJMoa1304923) and the Lancet (doi:10.1016/S0140-6736(13)61049-1) with clinical trial numbers NCT01508247 and NCT01507857.