The initial results of the Phase III efficacy trial of RTS,S were announced during the Bill & Melinda Gates Foundation Malaria Summit today and have been published online, in the New England Journal of Medicine.
These results confirm that the RTS,S vaccine candidate reduces episodes of clinical malaria by half in children aged 5–17 months over the first year of follow-up, that this vaccine candidate has an acceptable safety profile and is immunogenic in children in this age category.
The efficacy trial, conducted at 11 trial sites in sub-Saharan Africa, showed that RTS,S reduced the risk of clinical malaria and severe malaria by 56% and 47%, respectively, among 6,000 children aged 5 to 17 months, over a 12-month period following vaccination. These first Phase III data are in line with results from previous Phase II studies. Furthermore, the widespread coverage of insecticide treated bed nets (75%) in this study indicated that RTS,S can provide protection in addition to that offered by existing malaria control interventions.
Says Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health, during the announcement of the results: ” The final challenge is to ensure the vigor and sustainability of the biomedical research efforts that will be required to eliminate and ultimately eraditcate malaria.”