A Randomized Trial Assessing the Safety and Immunogenicity of AS01 and AS02 Adjuvanted RTS,S Malaria Vaccine Candidates in Children in Gabon |
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Authors: | 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 W Ripley Ballou Joe Cohen Peter G Kremsner |
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Institution: | 1. Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon.; 2. GlaxoSmithKline, Biologicals, Rixensart, Belgium.; 3. PATH Malaria Vaccine Initiative, Bethesda, Maryland, United States of America.; 4. Bill & Melinda Gates Foundation, Seattle, Washington, United States of America.; 5. Institute for Tropical Medicine, University of Tübingen, Tübingen, Germany.;BMSI-A*STAR, Singapore |
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Abstract: | BackgroundThe 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 FindingsIn this Phase II, double-blind study ({"type":"clinical-trial","attrs":{"text":"NCT00307021","term_id":"NCT00307021"}}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.ConclusionsRTS,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.Trial RegistrationClinicalTrials.gov. {"type":"clinical-trial","attrs":{"text":"NCT00307021","term_id":"NCT00307021"}}NCT00307021 |
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