Evaluation of the safety and immunogenicity of the RTS,S/AS01E malaria candidate vaccine when integrated in the expanded program of immunization.

Agnandji, ST; Asante, KP; Lyimo, J; Vekemans, J; Soulanoudjingar, SS; Owusu, R; Shomari, M; Leach, A; Fernandes, J; Dosoo, DORCID logo; +32 more...Chikawe, M; Issifou, S; Osei-Kwakye, K; Lievens, M; Paricek, M; Apanga, S; Mwangoka, G; Okissi, B; Kwara, E; Minja, R; Lange, J; Boahen, O; Kayan, K; Adjei, G; Chandramohan, DORCID logo; Jongert, E; Demoitié, M; Dubois, M; Carter, T; Vansadia, P; Villafana, T; Sillman, M; Savarese, B; Lapierre, D; Ballou, WR; Greenwood, BORCID logo; Tanner, M; Cohen, J; Kremsner, PG; Lell, B; Owusu-Agyei, S; Abdulla, S and (2010) Evaluation of the safety and immunogenicity of the RTS,S/AS01E malaria candidate vaccine when integrated in the expanded program of immunization. The Journal of infectious diseases, 202 (7). pp. 1076-1087. ISSN 0022-1899 DOI: 10.1086/656190
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BACKGROUND: The RTS,S/AS01(E) malaria candidate vaccine is being developed for immunization of African infants through the Expanded Program of Immunization (EPI). METHODS: This phase 2, randomized, open, controlled trial conducted in Ghana, Tanzania, and Gabon evaluated the safety and immunogenicity of RTS,S/AS01(E) when coadministered with EPI vaccines. Five hundred eleven infants were randomized to receive RTS,S/AS01(E) at 0, 1, and 2 months (in 3 doses with diphtheria, tetanus, and whole-cell pertussis conjugate [DTPw]; hepatitis B [HepB]; Haemophilus influenzae type b [Hib]; and oral polio vaccine [OPV]), RTS,S/AS01(E) at 0, 1, and 7 months (2 doses with DTPwHepB/Hib+OPV and 1 dose with measles and yellow fever), or EPI vaccines only. RESULTS: The occurrences of serious adverse events were balanced across groups; none were vaccine-related. One child from the control group died. Mild to moderate fever and diaper dermatitis occurred more frequently in the RTS,S/AS01(E) coadministration groups. RTS,S/AS01(E) generated high anti-circumsporozoite protein and anti-hepatitis B surface antigen antibody levels. Regarding EPI vaccine responses upon coadministration when considering both immunization schedules, despite a tendency toward lower geometric mean titers to some EPI antigens, predefined noninferiority criteria were met for all EPI antigens except for polio 3 when EPI vaccines were given with RTS,S/AS01(E) at 0, 1, and 2 months. However, when antibody levels at screening were taken into account, the rates of response to polio 3 antigens were comparable between groups. CONCLUSION: RTS,S/AS01(E) integrated in the EPI showed a favorable safety and immunogenicity evaluation. Trial registration. ClinicalTrials.gov identifier: NCT00436007 . GlaxoSmithKline study ID number: 106369 (Malaria-050).

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