A clinical study comparing the immune response to revaccination with intradermal BCG and aerosol BCG in previously BCG vaccinated healthy adult volunteers with and without Type 2 Diabetes (TB046)

Research summary

This is a phase 1 study exploring differences between the immunological responses to revaccination with intradermal-BCG and aerosol-inhaled BCG in healthy adults and those with pre-existing T2DM. There will be three study groups with twelve volunteers in each group (Table 2). Volunteers will be enrolled into groups based upon whether they have a diagnosis of T2DM. They will then be vaccinated with intradermal BCG (Groups A and C) or aerosolised BCG (Group B). Objectives: Co-Primary: To compare the immunological response of BCG re-vaccination by the aerosol inhaled route to the intradermal route in healthy historically intradermally BCGvaccinated volunteers. Co-Primary: To compare the immunological response of BCG re-vaccination by the intradermal route in historically intradermally BCG-vaccinated volunteers with Type 2 Diabetes and non-diabetic healthy adults.

Principal Investigator

Prof Helen McShane

Contact us

Email: vaccinetrials@ndm.ox.ac.uk

IRAS number

1008732