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End-point definition and trial design to advance tuberculosis vaccine development

Alberto L. Garcia-Basteiro, Richard G. White, Dereck Tait, Alexander C. Schmidt, Molebogeng X. Rangaka, Matthew Quaife, Elisa Nemes, Robin Mogg, Philip C. Hill, Rebecca C. Harris, Willem A. Hanekom, Mike Frick, Andrew Fiore-Gartland, Tom Evans, Alemnew F. Dagnew, Gavin Churchyard, Frank Cobelens, Marcel A. Behr, Mark Hatherill
European Respiratory Review 2022 31: 220044; DOI: 10.1183/16000617.0044-2022
Alberto L. Garcia-Basteiro
1Centro de Investigação em Sade de Manhiça (CISM), Maputo, Mozambique
2ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain
3Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFECT), Barcelona, Spain
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  • ORCID record for Alberto L. Garcia-Basteiro
  • For correspondence: alberto.garcia-basteiro@manhica.net
Richard G. White
4London School of Hygiene and Tropical Medicine, London, UK
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Dereck Tait
5International AIDS Vaccine Initiative (IAVI) NPC, Cape Town, South Africa
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Alexander C. Schmidt
6Bill and Melinda Gates Medical Research Institute, Cambridge, MA, USA
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Molebogeng X. Rangaka
7Institute for Global Health and MRC Clinical Trials Unit at University College London, London, UK
8CIDRI-AFRICA, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa
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Matthew Quaife
4London School of Hygiene and Tropical Medicine, London, UK
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Elisa Nemes
9South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Dept of Pathology, University of Cape Town, Cape Town, South Africa
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Robin Mogg
10Takeda Pharmaceutical Company Limited, Cambridge, MA, USA
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Philip C. Hill
11Centre for International Health, University of Otago, Dunedin, New Zealand
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Rebecca C. Harris
4London School of Hygiene and Tropical Medicine, London, UK
12Sanofi Pasteur, Singapore
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Willem A. Hanekom
13Africa Health Research Institute, KwaZulu-Natal, South Africa
14Division of Infection and Immunity, University College London, London, UK
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Mike Frick
15Treatment Action Group, New York, NY, USA
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Andrew Fiore-Gartland
16Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
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Tom Evans
17Vaccitech, Oxford, UK
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Alemnew F. Dagnew
6Bill and Melinda Gates Medical Research Institute, Cambridge, MA, USA
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Gavin Churchyard
18The Aurum Institute, Parktown, South Africa
19Vanderbilt University, Nashville, TN, USA
20University of the Witwatersrand, Johannesburg, South Africa
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Frank Cobelens
21Dept of Global Health and Amsterdam Institute for Global health and development, Amsterdam University Medical Centres, Amsterdam, The Netherlands
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Marcel A. Behr
22Dept of Medicine, McGill University; McGill International TB Centre, Montreal, QC, Canada
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Mark Hatherill
9South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Dept of Pathology, University of Cape Town, Cape Town, South Africa
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Article Information

vol. 31 no. 164
DOI 
https://doi.org/10.1183/16000617.0044-2022
PubMed 
35675923

Published By 
European Respiratory Society
Print ISSN 
0905-9180
Online ISSN 
1600-0617
History 
  • Received March 2, 2022
  • Accepted April 4, 2022
  • Published online June 7, 2022.

Copyright & Usage 
Copyright ©The authors 2022 This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact permissions@ersnet.org

Author Information

  1. Alberto L. Garcia-Basteiro1,2,3⇑,
  2. Richard G. White4,
  3. Dereck Tait5,
  4. Alexander C. Schmidt6,
  5. Molebogeng X. Rangaka7,8,
  6. Matthew Quaife4,
  7. Elisa Nemes9,
  8. Robin Mogg10,
  9. Philip C. Hill11,
  10. Rebecca C. Harris4,12,
  11. Willem A. Hanekom13,14,
  12. Mike Frick15,
  13. Andrew Fiore-Gartland16,
  14. Tom Evans17,
  15. Alemnew F. Dagnew6,
  16. Gavin Churchyard18,19,20,
  17. Frank Cobelens21,
  18. Marcel A. Behr22 and
  19. Mark Hatherill9
  1. 1Centro de Investigação em Sade de Manhiça (CISM), Maputo, Mozambique
  2. 2ISGlobal, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain
  3. 3Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFECT), Barcelona, Spain
  4. 4London School of Hygiene and Tropical Medicine, London, UK
  5. 5International AIDS Vaccine Initiative (IAVI) NPC, Cape Town, South Africa
  6. 6Bill and Melinda Gates Medical Research Institute, Cambridge, MA, USA
  7. 7Institute for Global Health and MRC Clinical Trials Unit at University College London, London, UK
  8. 8CIDRI-AFRICA, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa
  9. 9South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Dept of Pathology, University of Cape Town, Cape Town, South Africa
  10. 10Takeda Pharmaceutical Company Limited, Cambridge, MA, USA
  11. 11Centre for International Health, University of Otago, Dunedin, New Zealand
  12. 12Sanofi Pasteur, Singapore
  13. 13Africa Health Research Institute, KwaZulu-Natal, South Africa
  14. 14Division of Infection and Immunity, University College London, London, UK
  15. 15Treatment Action Group, New York, NY, USA
  16. 16Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
  17. 17Vaccitech, Oxford, UK
  18. 18The Aurum Institute, Parktown, South Africa
  19. 19Vanderbilt University, Nashville, TN, USA
  20. 20University of the Witwatersrand, Johannesburg, South Africa
  21. 21Dept of Global Health and Amsterdam Institute for Global health and development, Amsterdam University Medical Centres, Amsterdam, The Netherlands
  22. 22Dept of Medicine, McGill University; McGill International TB Centre, Montreal, QC, Canada
  1. Corresponding author: Alberto L. Garcia-Basteiro (alberto.garcia-basteiro{at}manhica.net)
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Article usage

Article usage: June 2022 to February 2023

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Jun 2022121102274
Jul 202223292195
Aug 20222515487
Sep 20221112463
Oct 20221912173
Nov 20222414383
Dec 2022187446
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Vol 31 Issue 164 Table of Contents
European Respiratory Review: 31 (164)
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End-point definition and trial design to advance tuberculosis vaccine development
Alberto L. Garcia-Basteiro, Richard G. White, Dereck Tait, Alexander C. Schmidt, Molebogeng X. Rangaka, Matthew Quaife, Elisa Nemes, Robin Mogg, Philip C. Hill, Rebecca C. Harris, Willem A. Hanekom, Mike Frick, Andrew Fiore-Gartland, Tom Evans, Alemnew F. Dagnew, Gavin Churchyard, Frank Cobelens, Marcel A. Behr, Mark Hatherill
European Respiratory Review Jun 2022, 31 (164) 220044; DOI: 10.1183/16000617.0044-2022

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End-point definition and trial design to advance tuberculosis vaccine development
Alberto L. Garcia-Basteiro, Richard G. White, Dereck Tait, Alexander C. Schmidt, Molebogeng X. Rangaka, Matthew Quaife, Elisa Nemes, Robin Mogg, Philip C. Hill, Rebecca C. Harris, Willem A. Hanekom, Mike Frick, Andrew Fiore-Gartland, Tom Evans, Alemnew F. Dagnew, Gavin Churchyard, Frank Cobelens, Marcel A. Behr, Mark Hatherill
European Respiratory Review Jun 2022, 31 (164) 220044; DOI: 10.1183/16000617.0044-2022
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  • Article
    • Abstract
    • Abstract
    • Introduction
    • Prevention of infection (POI) approaches to accelerate candidate vaccines into prevention of disease (POD) efficacy trials
    • Optimising TB disease end-points for future efficacy trials
    • End-point definition in vaccine trials including PLHIV
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