An Aspiration to Radically Shorten Phase 3 Tuberculosis Vaccine Trials

Philip C Hill¹, Frank Cobelens^{2

3}, Leonardo Martinez⁴, Marcel A Behr⁵, Gavin Churchyard^{6

7

8}, Tom Evans⁹, Andrew J Fiore-Gartland¹⁰, Alberto L Garcia-Basteiro^{11

12

13}, Willem Hanekom^{14

15}, Molebogeng X Rangaka^{16

17

18}, Johan Vekemans¹⁹, Richard G White²⁰

Affiliations

¹ Centre for International Health, University of Otago, Dunedin, New Zealand.
² Department of Global Health, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
³ Amsterdam Institute for Global Health and Development, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
⁴ Department of Epidemiology, School of Public Health, Boston University, Boston, Massachusetts, USA.
⁵ McGill International TB Centre, McGill University, Montreal, Quebec, Canada.
⁶ The Aurum Institute, Parktown, South Africa.
⁷ Department of Medicine, Vanderbilt University, Nashville, Tennessee, USA.
⁸ School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.
⁹ Vaccitech, Oxford, United Kingdom.
¹⁰ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
¹¹ Centro de Investigação em Saúde de Manhiça, Maputo, Mozambique.
¹² Instituto de Salud Global, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.
¹³ Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Barcelona, Spain.
¹⁴ Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa.
¹⁵ Division of Infection and Immunity, University College London, London, United Kingdom.
¹⁶ MRC Clinical Trials Unit, University College London, London, United Kingdom.
¹⁷ Institute for Global Health, University College London, London, United Kingdom.
¹⁸ Centre for Infectious Diseases Research Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
¹⁹ V4R, Brussels, Belgium.
²⁰ Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.

PMID: 37607272
DOI: 10.1093/infdis/jiad356

Editorial

An Aspiration to Radically Shorten Phase 3 Tuberculosis Vaccine Trials

Philip C Hill et al. J Infect Dis. 2023.

. 2023 Nov 2;228(9):1150-1153.

doi: 10.1093/infdis/jiad356.

Authors

Affiliations

¹ Centre for International Health, University of Otago, Dunedin, New Zealand.
² Department of Global Health, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
³ Amsterdam Institute for Global Health and Development, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
⁴ Department of Epidemiology, School of Public Health, Boston University, Boston, Massachusetts, USA.
⁵ McGill International TB Centre, McGill University, Montreal, Quebec, Canada.
⁶ The Aurum Institute, Parktown, South Africa.
⁷ Department of Medicine, Vanderbilt University, Nashville, Tennessee, USA.
⁸ School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.
⁹ Vaccitech, Oxford, United Kingdom.
¹⁰ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
¹¹ Centro de Investigação em Saúde de Manhiça, Maputo, Mozambique.
¹² Instituto de Salud Global, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.
¹³ Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Barcelona, Spain.
¹⁴ Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa.
¹⁵ Division of Infection and Immunity, University College London, London, United Kingdom.
¹⁶ MRC Clinical Trials Unit, University College London, London, United Kingdom.
¹⁷ Institute for Global Health, University College London, London, United Kingdom.
¹⁸ Centre for Infectious Diseases Research Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
¹⁹ V4R, Brussels, Belgium.
²⁰ Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.

PMID: 37607272
DOI: 10.1093/infdis/jiad356

Abstract

A new tuberculosis vaccine is a high priority. However, the classical development pathway is a major deterrent. Most tuberculosis cases arise within 2 years after Mycobacterium tuberculosis exposure, suggesting a 3-year trial period should be possible if sample size is large to maximize the number of early exposures. Increased sample size could be facilitated by working alongside optimized routine services for case ascertainment, with strategies for enhanced case detection and safety monitoring. Shortening enrolment could be achieved by simplifying screening criteria and procedures and strengthening site capacity. Together, these measures could enable radically shortened phase 3 tuberculosis vaccine trials.

Keywords: mycobacterium tuberculosis; phase 3; trial; tuberculosis; vaccine.

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Comment in

Improving Tuberculosis Vaccine Trial Efficiency: A Tough Nut to Crack.
McShane H. McShane H. J Infect Dis. 2023 Nov 2;228(9):1147-1149. doi: 10.1093/infdis/jiad360. J Infect Dis. 2023. PMID: 37602513 Free PMC article. No abstract available.

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An Aspiration to Radically Shorten Phase 3 Tuberculosis Vaccine Trials

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An Aspiration to Radically Shorten Phase 3 Tuberculosis Vaccine Trials

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