A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon

Bertrand Lell, Selidji Agnandji, Isabelle Von Glasenapp, Sonja Haertle, Sunny Oyakhiromen, Saadou Issifou, Johan Vekemans, Amanda Leach, Marc Lievens, Marie-Claude Dubois, Marie-Ange Demoitie, Terrell Carter, Tonya Villafana, Ripley Ballou, Joe Cohen, Peter Kremsner

    Research output: Contribution to journalArticle

    Abstract

    Background: The malaria vaccine candidate antigen RTS,S includes parts of the pre-erythrocytic stage circumsporozoite protein fused to the Hepatitis B surface antigen. Two Adjuvant Systems are in development for this vaccine, an oil-in water emulsion – based formulation (AS02) and a formulation based on liposomes (AS01).

    Methods & Principal Findings:
    In this Phase II, double-blind study (NCT00307021), 180 healthy Gabonese children aged 18 months to 4 years were randomized to receive either RTS,S/AS01E or RTS,S/AS02D, on a 0–1–2 month vaccination schedule. The children were followed-up daily for six days after each vaccination and monthly for 14 months. Blood samples were collected at 4 time-points. Both vaccines were well tolerated. Safety parameters were distributed similarly between the two groups. Both vaccines elicited a strong specific immune response after Doses 2 and 3 with a ratio of anti-CS GMT titers (AS02D/AS01E) of 0.88 (95% CI: 0.68–1.15) post-Dose 3. After Doses 2 and 3 of experimental vaccines, anti-CS and anti-HBs antibody GMTs were higher in children who had been previously vaccinated with at least one dose of hepatitis B vaccine compared to those not previously vaccinated.

    Conclusions: RTS,S/AS01E proved similarly as well tolerated and immunogenic as RTS,S/AS02D, completing an essential step in the age de-escalation process within the RTS,S clinical development plan.
    Original languageEnglish
    Article numbere7611
    Pages (from-to)1-9
    Number of pages9
    JournalPLoS One
    Volume4
    Issue number10
    DOIs
    Publication statusPublished - 27 Oct 2009

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  • Cite this

    Lell, B., Agnandji, S., Von Glasenapp, I., Haertle, S., Oyakhiromen, S., Issifou, S., Vekemans, J., Leach, A., Lievens, M., Dubois, M-C., Demoitie, M-A., Carter, T., Villafana, T., Ballou, R., Cohen, J., & Kremsner, P. (2009). A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon. PLoS One, 4(10), 1-9. [e7611]. https://doi.org/10.1371/journal.pone.0007611