Measuring indirect transmission-reducing effects in tuberculosis vaccine efficacy trials: why and how?
Tuberculosis is the leading bacterial cause of death globally. In 2021, 10·6 million people developed symptomatic tuberculosis and 1·6 million died. Seven promising vaccine candidates that aim to prevent tuberculosis disease in adolescents and adults are currently in late-stage clinical trials. Conventional phase 3 trials provide information on the direct protection conferred against infection or disease in vaccinated individuals, but they tell us little about possible indirect (ie, transmission-reducing) effects that afford protection to unvaccinated individuals. As a result, proposed phase 3 trial designs will not provide key information about the overall effect of introducing a vaccine programme. Information on the potential for indirect effects can be crucial for policy makers deciding whether and how to introduce tuberculosis vaccines into immunisation programmes. We describe the rationale for measuring indirect effects, in addition to direct effects, of tuberculosis vaccine candidates in pivotal trials and lay out several options for incorporating their measurement into phase 3 trial designs
TB vaccine theme
Project details
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Timeline
Target group
Vaccine
Type of protection of vaccine
Type of research
Partners involved
; AIGHD, Africa Health Research Institute, Aurum institute, Barcelona Institute for Global Health - ISGLOBAL, Boston University, CIBERINFEC, Heersink School of Medicine, Hospital Clínic–Universitat de Barcelona, Institute for Global Health and MRC Clinical Trials Unit, JHU India, LSHTM, Manhiça Health Research Center, School of Public Health, Atlanta, UCL, University of Alabama Birmingham, University of Otago