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Malaria vaccine candidate shows continued protection up to 18 months after vaccination

Results from a Phase III clinical trial published in PLOS Medicine update estimates of vaccine efficacy over 18 months of follow-up

29.07.2014

Results from a large-scale Phase III trial, published today in PLOS Medicine, show that the most clinically advanced malaria vaccine candidate, RTS,S, continues to protect young children and infants from clinical malaria up to 18 months after vaccination. The results were first presented in October 2013 at the 6th Multilateral Initiative on Malaria Pan-African Conference (MIM) in Durban, South Africa.

The study included 8,923 children aged 5 to 17 months and 6,537 infants aged 6 to 12 weeks and showed continued protection during 18 months of follow-up. The published results were from an independent evaluation of the efficacy of RTS,S by the 11 centres participating in the trial, and confirm those published in the New England Journal of Medicine several months ago, showing that the vaccine was efficacious in close to 50% of African children aged 5 to 17 months and in 30% of infants vaccinated between 6 and 12 weeks.

Pedro Alonso, Director of ISGlobal and Professor at the University of Barcelona, highlightd  that even though the vaccine has shown only partial efficacy, it still has an important role to play in malaria control strategies, particularly in countries with the highest burden of disease. "The vaccine will complement not only existing malaria prevention tools, such as insecticide-impregnated mosquito nets, but also the timely administration of suitable treatment of confirmed cases, " he concluded.

The new data, which are very much in line with results published to date, have led the pharmaceutical company GlaxoSmithKline to submit a regulatory application to the European Medicines Agency for malaria vaccine candidate, RTS,S. If authorisation is granted, the World Health Organisation will then be faced with the challenge of deciding how to include a vaccine with moderate efficacy in its global strategies to control and eventually eliminate malaria.

Reference: The RTS,S Clinical Trials Partnership (2014) Efficacy and Safety of the RTS,S/AS01 Malaria Vaccine during 18 Months after Vaccination: A Phase 3 Randomized, Controlled Trial in Children and Young Infants at 11 African Sites. PLoS Med 11(7): e1001685. doi:10.1371/journal.pmed.1001685