Phase 3 Trial of RTS,S Malaria Vaccine

GlaxoSmithKline announced positive results from its ongoing Phase 3 trial of its malaria vaccine candidate RTS,S. This multicenter trial was conducted in 6,000 children 5–17 months of age who were followed for a 12-month period following vaccination. Study data demonstrated that three doses of RTS,S reduced the risk of children experiencing clinical malaria and severe malaria by 56% and 47%, respectively. In a combined analysis that further included 15,460 infants 6–12 weeks old, data showed an overall 35% efficacy of RTS,S against malaria over a follow-up period of 0–22 months (average 11.5 months).

The RTS,S vaccine has been developed to trigger the immune system to defend against the Plasmodium falciparum malaria parasite when it first enters the human host's bloodstream and/or when the parasite infects liver cells. It is designed to prevent the parasite from infecting, maturing and multiplying in the liver, and from re-entering the bloodstream and infecting red blood cells, at which point the affected person would begin to show symptoms of the disease.

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