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Background  The  Plasmodium falciparum  pre-erythrocytic stage candidate vaccine RTS,S is being developed for protection of young children against malaria in sub-Saharan Africa. RTS,S formulated with the liposome based adjuvant AS01 E  or the oil-in-water based adjuvant AS02 D  induces  P. falciparum  circumsporozoite (CSP) antigen-specific antibody and T cell responses which have been associated with protection in the experimental malaria challenge model in adults.    Methods  This study was designed to evaluate the safety and immunogenicity induced over a 19 month period by three vaccination schedules (0,1-, 0,1,2- and 0,1,7-month) of RTS,S/AS01 E  and RTS,S/AS02 D  in children aged 5–17 months in two research centers in Ghana. Control Rabies vaccine using the 0,1,2-month schedule was used in one of two study sites.    Results  Whole blood antigen stimulation followed by intra-cellular cytokine staining showed RTS,S/AS01 E  induced CSP specific CD4 T cells producing IL-2, TNF-α, and IFN-γ. Higher T cell responses were induced by a 0,1,7-month immunization schedule as compared with a 0,1- or 0,1,2-month schedule. RTS,S/AS01 E  induced higher CD4 T cell responses as compared to RTS,S/AS02 D  when given on a 0,1,7-month schedule.    Conclusions  These findings support further Phase III evaluation of RTS,S/AS01 E . The role of immune effectors and immunization schedules on vaccine protection are currently under evaluation.    Trial Registration  ClinicalTrials.gov  NCT00360230

T Cell Responses to the RTS,S/AS01E and RTS,S/AS02D Malaria Candidate Vaccines Administered According to Different Schedules to Ghanaian Children