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Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian children

Lusingu, John, Olotu, Ally, Leach, Amanda J., Lievens, Marc, Vekemans, Johan, Olivier, Aurelie, Benns, Sarah, Olomi, Raimos, Msham, Salum, Lang, Trudie, Gould, Jayne, Hallez, Karin, Guerra, Yolanda, Njuguna, Patricia, Awuondo, Ken O., Malabeja, Anangisye, Abdul, Omar, Gesase, Samwel, Dekker, Denise, von Seidlein, Lorenz and et al. (2010). Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian children. PLoS One,5(11):e14090.

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IRMA ID 81704288xPUB258
Title Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian children
Author Lusingu, John
Olotu, Ally
Leach, Amanda J.
Lievens, Marc
Vekemans, Johan
Olivier, Aurelie
Benns, Sarah
Olomi, Raimos
Msham, Salum
Lang, Trudie
Gould, Jayne
Hallez, Karin
Guerra, Yolanda
Njuguna, Patricia
Awuondo, Ken O.
Malabeja, Anangisye
Abdul, Omar
Gesase, Samwel
Dekker, Denise
von Seidlein, Lorenz
et al.
Journal Name PLoS One
Publication Date 2010
Volume Number 5
Issue Number 11
ISSN 19326203   (check CDU catalogue open catalogue search in new window)
Start Page e14090
Total Pages 9
Place of Publication United States
Publisher Public Library of Science
Abstract The malaria vaccine candidate, RTS,S/AS01E, showed promising protective efficacy in a trial of Kenyan and Tanzanian children aged 5 to 17 months. Here we report on the vaccine’s safety and tolerability. The experimental design was a Phase 2b, two-centre, double-blind (observer- and participant-blind), randomised (1:1 ratio) controlled trial. Three doses of study or control (rabies) vaccines were administered intramuscularly at 1 month intervals. Solicited adverse events (AEs) were collected for 7 days after each vaccination. There was surveillance and reporting for unsolicited adverse events for 30 days after each vaccination. Serious adverse events (SAEs) were recorded throughout the study period which lasted for 14 months after dose 1 in Korogwe, Tanzania and an average of 18 months post-dose 1 in Kilifi, Kenya. Blood samples for safety monitoring of haematological, renal and hepatic functions were taken at baseline, 3, 10 and 14 months after dose 1. A total of 894 children received RTS,S/AS01E or rabies vaccine between March and August 2007. Overall, children vaccinated with RTS,S/AS01E had fewer SAEs (51/447) than children in the control group (88/447). One SAE episode in a RTS,S/AS01E recipient and nine episodes among eight rabies vaccine recipients met the criteria for severe malaria. Unsolicited AEs were reported in 78% of subjects in the RTS,S/AS01E group and 74% of subjects in the rabies vaccine group. In both vaccine groups, gastroenteritis and pneumonia were the most frequently reported unsolicited AE. Fever was the most frequently
observed solicited AE and was recorded after 11% of RTS,S/AS01E doses compared to 31% of doses of rabies vaccine. The candidate vaccine RTS,S/AS01E showed an acceptable safety profile in children living in a malaria-endemic area in East Africa. More data on the safety of RTS,S/AS01E will become available from the Phase 3 programme.
Keywords Malaria vaccine candidate
RTS,S/AS01E
Kenyan and Tanzanian children
DOI http://dx.doi.org/10.1371/journal.pone.0014090   (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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