Extended follow-up of children in a phase2b trial of the GMZ2 malaria vaccine
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Extended follow-up of children in a phase2b trial of the GMZ2 malaria vaccine. / Dassah, Sylvester; Adu, Bright; Sirima, Sodiomon B; Mordmüller, Benjamin; Ngoa, Ulysse Ateba; Atuguba, Frank; Arthur, Fareed K N; Mensah, Benedicta A; Kaddumukasa, Mark; Bang, Peter; Kremsner, Peter G; Mategula, Donnie; Flach, Clare; Milligan, Paul; Theisen, Michael.
In: Vaccine, Vol. 39, No. 31, 2021, p. 4314-4319.Research output: Contribution to journal › Journal article › Research › peer-review
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T1 - Extended follow-up of children in a phase2b trial of the GMZ2 malaria vaccine
AU - Dassah, Sylvester
AU - Adu, Bright
AU - Sirima, Sodiomon B
AU - Mordmüller, Benjamin
AU - Ngoa, Ulysse Ateba
AU - Atuguba, Frank
AU - Arthur, Fareed K N
AU - Mensah, Benedicta A
AU - Kaddumukasa, Mark
AU - Bang, Peter
AU - Kremsner, Peter G
AU - Mategula, Donnie
AU - Flach, Clare
AU - Milligan, Paul
AU - Theisen, Michael
N1 - Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
PY - 2021
Y1 - 2021
N2 - BACKGROUND: The GMZ2/alum candidate malaria vaccine had an efficacy of 14% (95% confidence interval [CI]: 3.6%, 23%) against clinical malaria over 6 months of follow-up in a phase2b multicentre trial in children 1-5 years of age. Here we report the extended follow up of safety and efficacy over 2 years.METHODS: A total of 1849 (GMZ2 = 926, rabies = 923) children aged 12-60 months were randomized to receive intramuscularly, either 3 doses of 100 μg GMZ2/alum or 3 doses of rabies vaccine as control 28 days apart. The children were followed-up for 24 months for clinical malaria episodes and adverse events. The primary endpoint was documented fever with parasitaemia of at least 5000/μL.RESULTS: There were 2,062 malaria episodes in the GMZ2/alum group and 2,115 in the rabies vaccine group in the intention-to-treat analysis, vaccine efficacy (VE) of 6.5% (95%: CI -1.6%, 14.0%). In children aged 1-2 years at enrolment, VE was 3.6% (95 %CI: -9.1%, 14.8%) in the first year and -4.1% (95 %CI: -18.7%, 87%) in the second year. In children aged 3-5 years at enrolment VE was 19.9% (95 %CI: 7.7%, 30.4%) in the first year and 6.3% (95 %CI: -10.2%, 20.3%) in the second year (interaction by year, P = 0.025, and by age group, P = 0.085). A total of 187 (GMZ2 = 91, rabies = 96) serious adverse events were recorded in 167 individuals over the entire period of the study. There were no GMZ2 vaccine related serious adverse events.CONCLUSIONS: GMZ2/alum was well tolerated. Follow-up over 2 years confirmed a low level of vaccine efficacy with slightly higher efficacy in older children, which suggests GMZ2 may act in concert with naturally acquired immunity.
AB - BACKGROUND: The GMZ2/alum candidate malaria vaccine had an efficacy of 14% (95% confidence interval [CI]: 3.6%, 23%) against clinical malaria over 6 months of follow-up in a phase2b multicentre trial in children 1-5 years of age. Here we report the extended follow up of safety and efficacy over 2 years.METHODS: A total of 1849 (GMZ2 = 926, rabies = 923) children aged 12-60 months were randomized to receive intramuscularly, either 3 doses of 100 μg GMZ2/alum or 3 doses of rabies vaccine as control 28 days apart. The children were followed-up for 24 months for clinical malaria episodes and adverse events. The primary endpoint was documented fever with parasitaemia of at least 5000/μL.RESULTS: There were 2,062 malaria episodes in the GMZ2/alum group and 2,115 in the rabies vaccine group in the intention-to-treat analysis, vaccine efficacy (VE) of 6.5% (95%: CI -1.6%, 14.0%). In children aged 1-2 years at enrolment, VE was 3.6% (95 %CI: -9.1%, 14.8%) in the first year and -4.1% (95 %CI: -18.7%, 87%) in the second year. In children aged 3-5 years at enrolment VE was 19.9% (95 %CI: 7.7%, 30.4%) in the first year and 6.3% (95 %CI: -10.2%, 20.3%) in the second year (interaction by year, P = 0.025, and by age group, P = 0.085). A total of 187 (GMZ2 = 91, rabies = 96) serious adverse events were recorded in 167 individuals over the entire period of the study. There were no GMZ2 vaccine related serious adverse events.CONCLUSIONS: GMZ2/alum was well tolerated. Follow-up over 2 years confirmed a low level of vaccine efficacy with slightly higher efficacy in older children, which suggests GMZ2 may act in concert with naturally acquired immunity.
U2 - 10.1016/j.vaccine.2021.06.024
DO - 10.1016/j.vaccine.2021.06.024
M3 - Journal article
C2 - 34175127
VL - 39
SP - 4314
EP - 4319
JO - Vaccine
JF - Vaccine
SN - 0264-410X
IS - 31
ER -
ID: 273578913