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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Safety of the malaria vaccine candidate, RTS,S/AS01
E
in 5 to 17 month old Kenyan and Tanzanian children
PLoS ONE, Volume 5, No. 11, Article e14090, Year 2010
Notification
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Description
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. © 2010 Lusingu et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2993932/bin/pone.0014090.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2993932/bin/pone.0014090.s002.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2993932/bin/pone.0014090.s003.pdf
Authors & Co-Authors
Lusingu, John Peter Andrea
Unknown Affiliation
Olotu, Ally Ibrahim
Unknown Affiliation
Leach, Amanda
Unknown Affiliation
Lievens, Marc J.J.
Unknown Affiliation
Vekemans, Johan
Unknown Affiliation
Olivier, Aurélie C.
Unknown Affiliation
Benns, Sarah
Unknown Affiliation
Olomi, Raimos M.
Unknown Affiliation
Msham, Salum
Unknown Affiliation
Lang, Trudie A.
Unknown Affiliation
Gould, J.
Unknown Affiliation
Hallez, Karin
Unknown Affiliation
Guerra, Yolanda
Unknown Affiliation
Njuguna, Patricia W.
Unknown Affiliation
Awuondo, Ken O.
Unknown Affiliation
Malabeja, Anangisye I.
Unknown Affiliation
Abdul, Omari
Unknown Affiliation
Gesase, Samwel
Unknown Affiliation
Dekker, Denise Myriam
Unknown Affiliation
Malle, Lincoln N.
Unknown Affiliation
Ismael, S.
Unknown Affiliation
Mturi, Neema
Unknown Affiliation
Drakeley, Chris J.
Unknown Affiliation
Savarese, Barbara M.
Unknown Affiliation
Villafana, Tonya L.
Unknown Affiliation
Ballou, William Ripley
Unknown Affiliation
Cohen, Joe D.
Unknown Affiliation
Riley, Eleanor M.
Unknown Affiliation
Lemnge, Martha M.M.
Unknown Affiliation
Marsh, Kevin
Unknown Affiliation
Bejon, Philip A.
Unknown Affiliation
Von-Seidlein, Lorenz
Unknown Affiliation
Statistics
Citations: 32
Authors: 32
Affiliations: 9
Identifiers
Doi:
10.1371/journal.pone.0014090
e-ISSN:
19326203
Research Areas
Disability
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Study Locations
Multi-countries
Kenya
Tanzania