Thursday, 31 January 2013

Enterovirus vaccine safe and effective against hand foot and mouth disease, Chinese trial shows

A trial conducted in Jiangsu has provided major step forward in the development of  a vaccine against enterovirus 71 - a member of the Picornaviridae family of viruses associated serious and fatal outbreaks of hand, foot, and mouth disease across Asia.
Published in The Lancet,  the results of a phase 2 trial of an enterovirus vaccine in more than 1100 infants and children in Jiangsu found that the vaccine had good immunogenicity and a low incidence of adverse effects.
The inactivated EV71 vaccine developed by Beijing Vigoo Biological used the EV71 strain was given in two doses a month apart, injected intramuscularly into the deltoid region in children aged 12—36 months and into the anterolateral side of thigh in infants aged 6—11 months.
The trial compared four different doses of vaccine, and all procuced  good antibody responses, with the best seen with an adjuvant 320 U formulation.
Antibody titres had significantly declined by eight months, suggesting a need for a booster shot. Generally, the vaccine had a good safety profile in all participants. Most reactions were mild or moderate and severe adverse reactions were uncommon.
Researchers say an enterovirus  vaccine is a public health priority because mortality rates with enterovirus 71 are as high as 82—94% in severe cases and the incidence of hand, foot, and mouth disease seems to be increasing across the Asia region
As a result of our findings, the adjuvant 320 U formulation has been selected for larger multicentre, randomised, double-blind, placebo-controlled trial in about 10 000 participants aged six—35 months.
Source: Lancet

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