title: RTS,S: Toward a first landmark on the Malaria Vaccine Technology Roadmap.
abstract: The Malaria Vaccine Technology Roadmap calls for a 2015 landmark goal of a first-generation malaria vaccine that has protective efficacy against severe disease and death, lasting longer than one year. This review focuses on product development efforts over the last five years of RTS,S, a pre-erythrocytic, recombinant subunit, adjuvanted, candidate malaria vaccine designed with this goal of a first-generation malaria vaccine in mind. RTS,S recently completed a successful pivotal Phase III safety, efficacy and immunogenicity study. Although vaccine efficacy was found to be modest, a substantial number of cases of clinical malaria were averted over a 3-4 years period, particularly in settings of significant disease burden. European regulators have subsequently adopted a positive opinion under the Article 58 procedure for an indication of active immunization of children aged 6 weeks up to 17 months against malaria caused by Plasmodium falciparum and against hepatitis B. Further evaluations of the benefit, risk, feasibility and cost-effectiveness of RTS,S are now anticipated through policy and financing reviews at the global and national levels.
authors.affiliation: PATH, 2201 Westlake Blvd, Suite 200, Seattle, WA 98141, USA. Electronic address: dkaslow@path.org.
authors.forename: David C
authors.initials: DC
authors.lastname: Kaslow
authors.affiliation: GSK Vaccines, Avenue Fleming, 20, Wavre, 1300, Belgium.
authors.forename: Sophie
authors.initials: S
authors.lastname: Biernaux
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D003362:Cost-Benefit Analysis; D055808:Drug Discovery; D006514:Hepatitis B Surface Antigens / Q000235:genetics / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007223:Infant; D008288:Malaria / Q000517:prevention & control*; D017780:Malaria Vaccines / Q000008:administration & dosage* / Q000191:economics / Q000276:immunology*; D016778:Malaria, Falciparum / Q000517:prevention & control*; D010963:Plasmodium falciparum / Q000276:immunology; D015800:Protozoan Proteins / Q000235:genetics / Q000276:immunology; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000191:economics / Q000276:immunology*
chemical_list: D006514:Hepatitis B Surface Antigens; D017780:Malaria Vaccines; D015800:Protozoan Proteins; C577001:RTS,S-AS01 vaccine; D014614:Vaccines, Synthetic; C041595:circumsporozoite protein, Protozoan
keywords: Circumsporozoite protein; Hepatitis B virus surface antigen; Malaria vaccines; Vaccine efficacy