A Human Lung Challenge Model to Evaluate the Safety and Immunogenicity of PPD and Live Bacillus Calmette-Guérin

What is it about?

This ‘first-in-man study’ demonstrates that bronchoscopic instillation of live BCG and PPD into the lungs of healthy participants, representing a gradient of TB susceptibility, is safe and feasible when performed in a TB endemic setting. Several BCG and PPD doses were evaluated and the minimal safest immunogenic dose identified. These data demonstrate the safety and feasibility of a lung-orientated mycobacterial human infection model and provide a solid foundation for the advancement of several lines of research including (i) the study TB immunopathogenesis, (ii) identification of biosignatures of TB risk, (iii) development of better models to evaluate vaccine efficacy, and (iv) optimising the route of vaccine delivery (respiratory tract versus intradermal).

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