A clinical trial evaluating the safety of an aerosol BCG controlled human infection model in assessing the immunogenicity of historical BCG vaccination and vaccination with ID93/GLA-SE in healthy adult volunteers (TB045)

Research summary

This is a phase 1b vaccine efficacy study of ID93/GLA-SE in historically BCG-vaccinated and BCG-naive healthy adult volunteers using an aerosol BCG challenge model. There will be four study groups with twelve volunteers in each group (Table 2). Volunteers will be randomised to eligible groups based upon their BCG vaccine status,and will either be given 2 μg ID93 + 5 μg GLA-SE at Day 0 and Day 56 (Group A and C) prior to BCG aerosol challenge,or proceed directly to BCG aerosol challenge without vaccination. The primary objective is to evaluate the safety of BCG challenge by the aerosol inhaled route in healthy volunteers and recently ID93/GLA-SE-vaccinated adult volunteers.

Principal Investigator

Prof Helen McShane

Contact us

Email: vaccinetrials@ndm.ox.ac.uk

IRAS number

1006525