Imperial College London
Professor Robert Wilkinson

ProfessorRobertWilkinson

Faculty of Medicine, Department of Infectious Disease

Professor in Infectious Diseases
 
 
 
//

Contact

 

r.j.wilkinson Website

 
 
//

Location

 

Commonwealth BuildingHammersmith Campus

//

Summary

 

Publications

Citation

BibTex format

@article{Van:2018:10.1056/NEJMoa1803484,
author = {Van, Der Meeren O and Hatherill, M and Nduba, V and Wilkinson, RJ and Muyoyeta, M and van, Brakel E and Ayles, HM and Henostroza, G and Thienemann, F and Scriba, TJ and Diacon, A and Blatner, GL and Demoitié, M-A and Tameris, M and Malahleha, M and Innes, JC and Hellstrom, E and Martinson, N and Singh, T and Akite, EJ and Azam, AK and Bollaerts, A and Ginsberg, AM and Evans, TG and Gillard, P and Tait, DR},
doi = {10.1056/NEJMoa1803484},
journal = {New England Journal of Medicine},
pages = {1621--1634},
title = {Phase 2b controlled trial of M72/AS01E vaccine to prevent tuberculosis},
url = {http://dx.doi.org/10.1056/NEJMoa1803484},
volume = {379},
year = {2018}
}
Download

RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundA vaccine to interrupt the transmission of tuberculosis is needed.MethodsWe conducted a randomized, double-blind, placebo-controlled, phase 2b trial of the M72/AS01E tuberculosis vaccine in Kenya, South Africa, and Zambia. Human immunodeficiency virus (HIV)–negative adults 18 to 50 years of age with latent M. tuberculosis infection (by interferon-γ release assay) were randomly assigned (in a 1:1 ratio) to receive two doses of either M72/AS01E or placebo intramuscularly 1 month apart. Most participants had previously received the bacille Calmette–Guérin vaccine. We assessed the safety of M72/AS01E and its efficacy against progression to bacteriologically confirmed active pulmonary tuberculosis disease. Clinical suspicion of tuberculosis was confirmed with sputum by means of a polymerase-chain-reaction test, mycobacterial culture, or both.ResultsWe report the primary analysis (conducted after a mean of 2.3 years of follow-up) of the ongoing trial. A total of 1786 participants received M72/AS01E and 1787 received placebo, and 1623 and 1660 participants in the respective groups were included in the according-to-protocol efficacy cohort. A total of 10 participants in the M72/AS01E group met the primary case definition (bacteriologically confirmed active pulmonary tuberculosis, with confirmation before treatment), as compared with 22 participants in the placebo group (incidence, 0.3 cases vs. 0.6 cases per 100 person-years). The vaccine efficacy was 54.0% (90% confidence interval [CI], 13.9 to 75.4; 95% CI, 2.9 to 78.2; P=0.04). Results for the total vaccinated efficacy cohort were similar (vaccine efficacy, 57.0%; 90% CI, 19.9 to 76.9; 95% CI, 9.7 to 79.5; P=0.03). There were more unsolicited reports of adverse events in the M72/AS01E group (67.4%) than in the placebo group (45.4%) within 30 days after injection, with the difference attributed mainly to injection-site reactions and influenza-like symptoms. Serious adverse events, potent
AU  - Van,Der Meeren O
AU  - Hatherill,M
AU  - Nduba,V
AU  - Wilkinson,RJ
AU  - Muyoyeta,M
AU  - van,Brakel E
AU  - Ayles,HM
AU  - Henostroza,G
AU  - Thienemann,F
AU  - Scriba,TJ
AU  - Diacon,A
AU  - Blatner,GL
AU  - Demoitié,M-A
AU  - Tameris,M
AU  - Malahleha,M
AU  - Innes,JC
AU  - Hellstrom,E
AU  - Martinson,N
AU  - Singh,T
AU  - Akite,EJ
AU  - Azam,AK
AU  - Bollaerts,A
AU  - Ginsberg,AM
AU  - Evans,TG
AU  - Gillard,P
AU  - Tait,DR
DO  - 10.1056/NEJMoa1803484
EP  - 1634
PY  - 2018///
SN  - 0028-4793
SP  - 1621
TI  - Phase 2b controlled trial of M72/AS01E vaccine to prevent tuberculosis
T2  - New England Journal of Medicine
UR  - http://dx.doi.org/10.1056/NEJMoa1803484
UR  - http://hdl.handle.net/10044/1/64177
VL  - 379
ER  -
Download