title: Mosquirix (RTS,S): a novel vaccine for the prevention of Plasmodium falciparum malaria.
abstract: OBJECTIVE
  To summarize and evaluate the literature for Mosquirix (RTS,S) and provide insight into the therapeutic and economic controversies of this novel malaria vaccine candidate.
  
  
  METHODS
  A systematic literature search was performed using the terms Mosquirix; RTS,S; malaria; vaccine; and Plasmodium in MEDLINE (1948-November 2011), EMBASE (1980-November 2011), International Pharmaceutical Abstracts (1970-November 2011), Google, and Google Scholar.
  
  
  METHODS
  Clinical trials describing vaccine development, pharmacology, pharmacokinetics, efficacy, and safety were reviewed. For efficacy, clinical trials were reviewed that reported acquisition of malarial disease. Information regarding study design, population, study period, baseline characteristics, clinical outcomes, results, and assessors of quality was extracted.
  
  
  RESULTS
  Five randomized controlled trials and 4 follow-up extension studies were identified. In Phase 2 trials, vaccine efficacy rates were 33-65% in infants and 30-53% in children for preventing the first episode of clinical disease. In Phase 3 trials, vaccine efficacy was 56% in children aged 5-17 months. RTS,S reduced the number of clinical malaria episodes and prevented severe malaria in several studies. The follow-up period for vaccine efficacy ranged from 6 to 45 months. RTS,S 25 μg is administered intramuscularly as 3 injections given 1 month apart for infants and children. RTS,S appears to be generally well tolerated. A few cases of meningitis and seizures (within 7 days of vaccination) have been reported.
  
  
  CONCLUSIONS
  RTS,S has demonstrated efficacy and safety in Phase 1, 2, and 3 trials, and has the potential to decrease morbidity and mortality from malaria worldwide. Major challenges include determination of the duration of immunity, assessment of its cost-effectiveness, its use in special populations, and its dissemination in endemic regions. Pending further studies, RTS,S has the potential to become the benchmark as the first effective vaccine against malaria.
authors.affiliation: Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, BC,  Canada.
authors.forename: Kyle J
authors.initials: KJ
authors.lastname: Wilby
authors.forename: Tim T Y
authors.initials: TT
authors.lastname: Lau
authors.forename: Samuel E
authors.initials: SE
authors.lastname: Gilchrist
authors.forename: Mary H H
authors.initials: MH
authors.lastname: Ensom
mesh_terms: D006801:Humans; D017780:Malaria Vaccines / Q000494:pharmacology / Q000627:therapeutic use*; D016778:Malaria, Falciparum / Q000517:prevention & control*; D010963:Plasmodium falciparum / Q000276:immunology*
chemical_list: D017780:Malaria Vaccines