Imperial College London
Professor Robert Wilkinson

ProfessorRobertWilkinson

Faculty of Medicine, Department of Infectious Disease

Professor in Infectious Diseases
 
 
 
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Contact

 

r.j.wilkinson Website

 
 
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Location

 

Commonwealth BuildingHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Tait:2019:10.1056/NEJMoa1909953,
author = {Tait, DR and Hatherill, M and van, der Meeren O and Ginsburg, AM and Van, Brakel E and Salaun, B and Scriba, TJ and Akite, EJ and Ayles, HM and Bollaerts, A and Demoitié, M-A and Diacon, A and Evans, TG and Gillard, P and Hellstrm, E and Innes, JC and Lempicki, M and Malahleha, M and Martinson, N and Vela, DM and Muyoyeta, M and Nduba, V and Pascal, TG and Tameris, M and Thienemann, F and Wilkinson, RJ and Roman, F},
doi = {10.1056/NEJMoa1909953},
journal = {New England Journal of Medicine},
pages = {2429--2439},
title = {Final analysis of a trial of M72/AS01E vaccine to prevent tuberculosis},
url = {http://dx.doi.org/10.1056/NEJMoa1909953},
volume = {381},
year = {2019}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundResults of an earlier analysis of a trial of the M72/AS01E candidate vaccine against Mycobacterium tuberculosis showed that in infected adults, the vaccine provided 54.0% protection against active pulmonary tuberculosis disease, without evident safety concerns. We now report the results of the 3-year final analysis of efficacy, safety, and immunogenicity.MethodsFrom August 2014 through November 2015, we enrolled adults 18 to 50 years of age with M. tuberculosis infection (defined by positive results on interferon-γ release assay) without evidence of active tuberculosis disease at centers in Kenya, South Africa, and Zambia. Participants were randomly assigned in a 1:1 ratio to receive two doses of either M72/AS01E or placebo, administered 1 month apart. The primary objective was to evaluate the efficacy of M72/AS01E to prevent active pulmonary tuberculosis disease according to the first case definition (bacteriologically confirmed pulmonary tuberculosis not associated with human immunodeficiency virus infection). Participants were followed for 3 years after the second dose. Participants with clinical suspicion of tuberculosis provided sputum samples for polymerase-chain-reaction assay, mycobacterial culture, or both. Humoral and cell-mediated immune responses were evaluated until month 36 in a subgroup of 300 participants. Safety was assessed in all participants who received at least one dose of M72/AS01E or placebo.ResultsA total of 3575 participants underwent randomization, of whom 3573 received at least one dose of M72/AS01E or placebo, and 3330 received both planned doses. Among the 3289 participants in the according-to-protocol efficacy cohort, 13 of the 1626 participants in the M72/AS01E group, as compared with 26 of the 1663 participants in the placebo group, had cases of tuberculosis that met the first case definition (incidence, 0.3 vs. 0.6 cases per 100 person-years). The vaccine efficacy at month 36 was 49.7% (90% confidence interval [CI]
AU  - Tait,DR
AU  - Hatherill,M
AU  - van,der Meeren O
AU  - Ginsburg,AM
AU  - Van,Brakel E
AU  - Salaun,B
AU  - Scriba,TJ
AU  - Akite,EJ
AU  - Ayles,HM
AU  - Bollaerts,A
AU  - Demoitié,M-A
AU  - Diacon,A
AU  - Evans,TG
AU  - Gillard,P
AU  - Hellstrm,E
AU  - Innes,JC
AU  - Lempicki,M
AU  - Malahleha,M
AU  - Martinson,N
AU  - Vela,DM
AU  - Muyoyeta,M
AU  - Nduba,V
AU  - Pascal,TG
AU  - Tameris,M
AU  - Thienemann,F
AU  - Wilkinson,RJ
AU  - Roman,F
DO  - 10.1056/NEJMoa1909953
EP  - 2439
PY  - 2019///
SN  - 0028-4793
SP  - 2429
TI  - Final analysis of a trial of M72/AS01E vaccine to prevent tuberculosis
T2  - New England Journal of Medicine
UR  - http://dx.doi.org/10.1056/NEJMoa1909953
UR  - https://www.nejm.org/doi/10.1056/NEJMoa1909953
UR  - http://hdl.handle.net/10044/1/74245
VL  - 381
ER  -
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