RT Journal Article
SR Electronic
T1 End-point definition and trial design to advance tuberculosis vaccine development
JF European Respiratory Review
JO EUROPEAN RESPIRATORY REVIEW
FD European Respiratory Society
SP 220044
DO 10.1183/16000617.0044-2022
VO 31
IS 164
A1 Garcia-Basteiro, Alberto L.
A1 White, Richard G.
A1 Tait, Dereck
A1 Schmidt, Alexander C.
A1 Rangaka, Molebogeng X.
A1 Quaife, Matthew
A1 Nemes, Elisa
A1 Mogg, Robin
A1 Hill, Philip C.
A1 Harris, Rebecca C.
A1 Hanekom, Willem A.
A1 Frick, Mike
A1 Fiore-Gartland, Andrew
A1 Evans, Tom
A1 Dagnew, Alemnew F.
A1 Churchyard, Gavin
A1 Cobelens, Frank
A1 Behr, Marcel A.
A1 Hatherill, Mark
YR 2022
UL http://err.ersjournals.com/content/31/164/220044.abstract
AB 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.Given the substantial resources required for efficacy trials and the limited amount of funding available for TB vaccine development, it is crucial that trial end-points are carefully selected and study designs are as efficient as possible. https://bit.ly/3KmTGgZ