Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian Children
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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; Lievens, Marc; Vekemans, Johan; Olivier, Aurélie; 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; Malle, Lincoln; Ismael, Sadiki; Mturi, Neema; Drakeley, Chris J; Savarese, Barbara; Villafana, Tonya; Ballou, W Ripley; Cohen, Joe; Riley, Eleanor M; Lemnge, Martha M; Marsh, Kevin; Bejon, Philip; von Seidlein, Lorenz.
In: P L o S One, Vol. 5, No. 11, 01.01.2010, p. e14090.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian Children
AU - Lusingu, John
AU - Olotu, Ally
AU - Leach, Amanda
AU - Lievens, Marc
AU - Vekemans, Johan
AU - Olivier, Aurélie
AU - Benns, Sarah
AU - Olomi, Raimos
AU - Msham, Salum
AU - Lang, Trudie
AU - Gould, Jayne
AU - Hallez, Karin
AU - Guerra, Yolanda
AU - Njuguna, Patricia
AU - Awuondo, Ken O
AU - Malabeja, Anangisye
AU - Abdul, Omar
AU - Gesase, Samwel
AU - Dekker, Denise
AU - Malle, Lincoln
AU - Ismael, Sadiki
AU - Mturi, Neema
AU - Drakeley, Chris J
AU - Savarese, Barbara
AU - Villafana, Tonya
AU - Ballou, W Ripley
AU - Cohen, Joe
AU - Riley, Eleanor M
AU - Lemnge, Martha M
AU - Marsh, Kevin
AU - Bejon, Philip
AU - von Seidlein, Lorenz
PY - 2010/1/1
Y1 - 2010/1/1
N2 - The malaria vaccine candidate, RTS,S/AS01(E), 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/AS01(E) or rabies vaccine between March and August 2007. Overall, children vaccinated with RTS,S/AS01(E) had fewer SAEs (51/447) than children in the control group (88/447). One SAE episode in a RTS,S/AS01(E) 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/AS01(E) 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/AS01(E) doses compared to 31% of doses of rabies vaccine. The candidate vaccine RTS,S/AS01(E) showed an acceptable safety profile in children living in a malaria-endemic area in East Africa. More data on the safety of RTS,S/AS01(E) will become available from the Phase 3 programme.
AB - The malaria vaccine candidate, RTS,S/AS01(E), 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/AS01(E) or rabies vaccine between March and August 2007. Overall, children vaccinated with RTS,S/AS01(E) had fewer SAEs (51/447) than children in the control group (88/447). One SAE episode in a RTS,S/AS01(E) 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/AS01(E) 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/AS01(E) doses compared to 31% of doses of rabies vaccine. The candidate vaccine RTS,S/AS01(E) showed an acceptable safety profile in children living in a malaria-endemic area in East Africa. More data on the safety of RTS,S/AS01(E) will become available from the Phase 3 programme.
KW - Alanine Transaminase
KW - Creatinine
KW - Double-Blind Method
KW - Fever
KW - Gastroenteritis
KW - Humans
KW - Infant
KW - Kenya
KW - Malaria Vaccines
KW - Malaria, Falciparum
KW - Pain
KW - Plasmodium falciparum
KW - Pneumonia
KW - Rabies Vaccines
KW - Sleep Stages
KW - Tanzania
KW - Vaccination
U2 - 10.1371/journal.pone.0014090
DO - 10.1371/journal.pone.0014090
M3 - Journal article
C2 - 21124768
VL - 5
SP - e14090
JO - PLoS ONE
JF - PLoS ONE
SN - 1932-6203
IS - 11
ER -
ID: 33325688