First results from a large-scale Phase III trial of RTS,S, published online on October 18, 2011 in the New England Journal of Medicine (NEJM), show the malaria vaccine candidate to provide young African children with significant protection against clinical and severe malaria with an acceptable safety and tolerability profile. The results were announced today at the Malaria Forum hosted by the Bill & Melinda Gates Foundation in Seattle, Washington. Half the world's population is at risk of malaria. The disease is responsible for close to 800,000 deaths each year, most of whom are children under five in sub-Saharan Africa The trial, conducted at eleven trial sites in seven countries across sub-Saharan Africa, including a University of North Carolina-led site in Lilongwe, Malawi, showed that three doses of RTS,S reduced the risk of children experiencing clinical malaria and severe malaria by 56 percent and 47 percent, respectively. This analysis was performed on data from the first 6,000 children aged 5 months to 17 months, over a 12-month period following vaccination. Clinical malaria results in high fevers and chills. It can rapidly develop into severe malaria, typified by serious effects on the blood, brain, or kidneys that can prove fatal. These first Phase III results are in line with those from previous Phase II studies. The widespread coverage of insecticide-treated bed nets (75 percent) in this study indicated that RTS,S can provide protection in addition to that already offered by existing malaria control interventions. The trial is ongoing and efficacy and safety results in 6 week- old to 12 week-old infants are expected by the end of 2012. These data will provide an understanding of the efficacy profile of the RTS,S malaria vaccine candidate in this age group, for both clinical and severe malaria.
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