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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

Lell, Bertrand, Agnandji, Selidji, von Glasenapp, Isabelle, Haertle, Sonja, Oyakhiromen, Sunny, Issifou, Saadou, Vekemans, Johan, Leach, Amanda J., Lievens, Marc, Dubois, Marie-Claude, Demoitie, Marie-Ange, Carter, Terrell, Villafana, Tonya, Ballou, W. Ripley, Cohen, Joe and Kremsner, Peter G. (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):e7611-1-e7611-9.

Document type: Journal Article
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IRMA ID 75039815xPUB507
Title A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS, S malaria vaccine candidates in children in Gabon
Author Lell, Bertrand
Agnandji, Selidji
von Glasenapp, Isabelle
Haertle, Sonja
Oyakhiromen, Sunny
Issifou, Saadou
Vekemans, Johan
Leach, Amanda J.
Lievens, Marc
Dubois, Marie-Claude
Demoitie, Marie-Ange
Carter, Terrell
Villafana, Tonya
Ballou, W. Ripley
Cohen, Joe
Kremsner, Peter G.
Journal Name PLoS One
Publication Date 2009
Volume Number 4
Issue Number 10
ISSN 1932-6203   (check CDU catalogue  open catalogue search in new window)
Scopus ID 2-s2.0-70449561070
Start Page e7611-1
End Page e7611-9
Total Pages 9
Place of Publication United States
Publisher Public Library of Science
HERDC Category C1 - Journal Article (DIISR)
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.
DOI http://dx.doi.org/10.1371/journal.pone.0007611   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)


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