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Malaria vaccine effective in children

Clinical Question:
Is a novel RTS,S malaria vaccine safe and effective in children?

Bottom Line:
A novel malaria vaccine (RTS,S/AS01) reduces the incidence of clinical malaria by approximately 50%, (LOE = 1b)

Agnandji ST, Lell B, Soulanoudjingar SS, et al, for the RTS,S Clinical Trials Partnership. First results of phase 3 trials of RTS,S/AS01 malaria vaccine in African children. N Engl J Med 2011;365(20):1863-1875.  [PMID:22007715]

Study Design:
Randomized controlled trial (double-blinded)

Industry + foundation


Malaria remains an important public health problem, with more than 781,000 deaths annually, most in African children. The Gates Foundation was a cosponsor of this research with GlaxoSmithKline to develop and test a vaccine for malaria in children. Two groups of children were enrolled: those aged 6 weeks to 12 weeks, and those aged 5 months to 17 months. Within each age group, children were randomized to receive either 3 monthly vaccinations; 3 monthly vaccinations, plus a booster vaccination 18 months after the third dose; or a comparator vaccination (rabies for the older children and meningococcal vaccine for the younger children). The mean follow-up was 9 months for the younger group and 18 months for the older group, and during that time their parents were encouraged to seek care for any illness. Approximately 75% of children were available for follow-up at the end of the study. At the time of publication, detailed data were not yet available for the younger age group. In the older age group, the vaccine reduced the number of episodes of malaria (fever plus at least 5000 parasites per cubic millimeter) from 1.08 per person-year to 0.55 per person-year (vaccine efficacy = 50.4%; 95% CI, 45.8% - 54.6%). Efficacy against severe malaria was similar (45.1%; 23.8% - 60.5%). Adverse events, including febrile seizures, were similar among all 3 groups.


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