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Clinical trials of tuberculosis vaccines in the era of increased access to preventive antibiotic treatment

Rangaka, MX; Frick, M; Churchyard, G; García-Basteiro, AL; Hatherill, M; Hanekom, W; Hill, PC; ... Cobelens, F; + view all (2023) Clinical trials of tuberculosis vaccines in the era of increased access to preventive antibiotic treatment. The Lancet Respiratory Medicine , 11 (4) pp. 380-390. 10.1016/S2213-2600(23)00084-X.

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Abstract

Approximately 10·6 million people worldwide develop tuberculosis each year, representing a failure in epidemic control that is accentuated by the absence of effective vaccines to prevent infection or disease in adolescents and adults. Without effective vaccines, tuberculosis prevention has relied on testing for Mycobacterium tuberculosis infection and treating with antibiotics to prevent progression to tuberculosis disease, known as tuberculosis preventive treatment (TPT). Novel tuberculosis vaccines are in development and phase 3 efficacy trials are imminent. The development of effective, shorter, and safer TPT regimens has broadened the groups eligible for TPT beyond people with HIV and child contacts of people with tuberculosis; future vaccine trials will be undertaken in an era of increased TPT access. Changes in the prevention standard will have implications for tuberculosis vaccine trials of disease prevention, for which safety and sufficient accrual of cases are crucial. In this paper, we examine the urgent need for trials that allow the evaluation of new vaccines and fulfil the ethical duty of researchers to provide TPT. We observe how HIV vaccine trials have incorporated preventive treatment in the form of pre-exposure prophylaxis, propose trial designs that integrate TPT, and summarise considerations for each design in terms of trial validity, efficiency, participant safety, and ethics.

Type: Article
Title: Clinical trials of tuberculosis vaccines in the era of increased access to preventive antibiotic treatment
Location: England
DOI: 10.1016/S2213-2600(23)00084-X
Publisher version: https://doi.org/10.1016/S2213-2600(23)00084-X
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher's terms and conditions.
Keywords: Adult, Adolescent, Child, Humans, Tuberculosis, Tuberculosis Vaccines, Antitubercular Agents, Clinical Protocols
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Infection and Immunity
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health > Infection and Population Health
URI: https://discovery.ucl.ac.uk/id/eprint/10167887
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