a randomized trial assessing the safety and immunogenicity of as01 and as02 adjuvanted rts,s malaria vaccine candidates in children in gabon一项随机试验的安全性和免疫原性评估as01 as02佐剂的rts,s疟疾疫苗候选人在加蓬的儿童.pdfVIP
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a randomized trial assessing the safety and immunogenicity of as01 and as02 adjuvanted rts,s malaria vaccine candidates in children in gabon一项随机试验的安全性和免疫原性评估as01 as02佐剂的rts,s疟疾疫苗候选人在加蓬的儿童
A Randomized Trial Assessing the Safety and
Immunogenicity of AS01 and AS02 Adjuvanted RTS,S
Malaria Vaccine Candidates in Children in Gabon
Bertrand Lell1,5*, Selidji Agnandji1,5, Isabelle von Glasenapp1,5, Sonja Haertle 1,5, Sunny Oyakhiromen1,5,
1,5 2 2 2 2
Saadou Issifou , Johan Vekemans , Amanda Leach , Marc Lievens , Marie-Claude Dubois , Marie-Ange
2 3 3 4 2 1,5
Demoitie , Terrell Carter , Tonya Villafana , W. Ripley Ballou , Joe Cohen , Peter G. Kremsner
´ ´
1 Medical Research Unit, Albert Schweitzer Hospital, Lambarene, 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
¨ ¨
Tubingen, Tubingen, Germany
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 (NC, 180 healthy Gabonese children aged 18
months to 4 years were randomized to receive either RTS,S/AS01 or RTS,S/AS02 , on a 0–1–2 month vaccination schedule.
E D
The chi
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