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

Garcia-Basteiro, AL; White, RG; Tait, D; Schmidt, AC; Rangaka, MX; Quaife, M; Nemes, E; ... Hatherill, M; + view all (2022) End-point definition and trial design to advance tuberculosis vaccine development. European respiratory review : an official journal of the European Respiratory Society , 31 (164) , Article 220044. 10.1183/16000617.0044-2022. Green open access

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Abstract

Tuberculosis (TB) remains a leading infectious cause of death worldwide and the coronavirus disease 2019 pandemic has negatively impacted the global TB burden of disease indicators. If the targets of TB mortality and incidence reduction set by the international community are to be met, new more effective adult and adolescent TB vaccines are urgently needed. There are several new vaccine candidates at different stages of clinical development. Given the limited funding for vaccine development, it is crucial that trial designs are as efficient as possible. Prevention of infection (POI) approaches offer an attractive opportunity to accelerate new candidate vaccines to advance into large and expensive prevention of disease (POD) efficacy trials. However, POI approaches are limited by imperfect current tools to measure Mycobacterium tuberculosis infection end-points. POD trials need to carefully consider the type and number of microbiological tests that define TB disease and, if efficacy against subclinical (asymptomatic) TB disease is to be tested, POD trials need to explore how best to define and measure this form of TB. Prevention of recurrence trials are an alternative approach to generate proof of concept for efficacy, but optimal timing of vaccination relative to treatment must still be explored. Novel and efficient approaches to efficacy trial design, in addition to an increasing number of candidates entering phase 2-3 trials, would accelerate the long-standing quest for a new TB vaccine.

Type: Article
Title: End-point definition and trial design to advance tuberculosis vaccine development
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1183/16000617.0044-2022
Publisher version: https://doi.org/10.1183/16000617.0044-2022
Language: English
Additional information: © The Authors 2022. This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0 (https://creativecommons.org/licenses/by-nc/4.0/).
UCL classification: UCL
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
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
URI: https://discovery.ucl.ac.uk/id/eprint/10150582
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