CIDRAP has published NEWS SCAN: H7N9 serology study, Ebola suspected in DRC, steroid recall, EV71 vaccine trial, measles in Europe. Excerpt:
A phase 3 study of an enterovirus 71 (EV71) vaccine developed in China for preventing hand, foot, and mouth disease suggests that it is highly effective, with an acceptable safety profile, researchers reported today in The Lancet.
The study took place from January 2012 through March 2013 and included 10,245 Chinese children ages 6 to 35 months. About half received an alum-adjuvant placebo and half received two doses of the vaccine administered 28 days apart. Developed by Beijing Vigoo Biological, the vaccine is a Vero cell alum-adjuvanted product targeted to the C4 genotype, the most common in mainland China. The study limited the number of vaccinated kids in each location to avoid any possible herd immunity effect.
Vaccine efficacy against lab-confirmed EV71 infection was 90% (95% confidence interval [CI], 67.1% to 96.9%) and against EV71-associated disease was 80.4% (95% CI, 58.2% to 90.8%). The percentage of serious adverse events was consistent with previous findings: 1.2% in the vaccine group and 1.5% in the placebo group. Though the disease can be severe, few participants were hospitalized, a factor that played a role in the wide 95% confidence interval for efficacy, the group noted.
