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

Selidji T. Agnandji, Kwaku Poku Asante, John Lyimo, Johan Vekemans, Solange S. Soulanoudjingar, Ruth Owusu, Mwanajaa Shomari, Amanda Leach, Jose Fernandes, David Dosoo, Maria Chikawe, Saadou Issifou, Kingsley Osei-Kwakye, Marc Lievens, Maria Paricek, Stephen Apanga, Grace Mwangoka, Blaise Okissi, Evans Kwara, Rose MinjaJorn Lange, Owusu Boahen, Kingsley Kayan, George Adjei, Daniel Chandramohan, Erik Jongert, Marie Ange Demoitié, Marie Claude Dubois, Terrel Carter, Preeti Vansadia, Tonya Villafana, Marla Sillman, Barbara Savarese, Didier Lapierre, William Ripley Ballou, Brian Greenwood, Marcel Tanner, Joe Cohen, Peter G. Kremsner, Bertrand Lell, Seth Owusu-Agyei, Salim Abdulla

    Research output: Contribution to journalArticlepeer-review


    Background: The RTS,S/AS01E 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/AS01E when coadministered with EPI vaccines. Five hundred eleven infants were randomized to receive RTS,S/AS01E 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/AS01E 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/AS01E coadministration groups. RTS,S/AS01E 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/AS01E 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/AS01E integrated in the EPI showed a favorable safety and immunogenicity evaluation.

    Trial registration: ClinicalTrials.gov identifier: NCT00436007. GlaxoSmithKline study ID number: 106369 (Malaria-050).

    Original languageEnglish
    Pages (from-to)1076-1087
    Number of pages12
    JournalJournal of Infectious Diseases
    Issue number7
    Early online date24 Aug 2010
    Publication statusPublished - 1 Oct 2010


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