TB046

• Research type

  Research Study

• Full title

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

• IRAS ID

  1008732

• Contact name

  Helen McShane

• Contact email

  helen.mcshane@ndm.ox.ac.uk

• Sponsor organisation

  University of Oxford

• Research summary

  Currently, the only licensed vaccine against TB, BCG, is injected under the skin (intradermal). This works well as a single dose vaccination against TB in childhood but is often ineffective in adults. Previous studies have investigated the benefit of booster doses of intradermal BCG, although these have not shown a clear benefit in reducing the risk of
  TB disease there is emerging evidence that it may reduce the risk of M.tb infection in some populations. Certain groups are at a higher risk of infection with Mycobacterium tuberculosis, the bacterium that causes TB. An important risk group are those with
  Diabetes Mellitus, who are both at an increased risk of becoming infected and dying from the disease. The reason for this is unclear. This study will provide data on the immune response to booster vaccination with BCG. We will compare how these responses differ between routes of vaccine delivery (aerosol inhaled BCG versus intradermal), and also explore how the immune response to revaccination differs in adults with Type 2 diabetes. We will use the findings to explore the potential benefits of aerosol vaccination and to investigate differences in the immune responses in diabetic individuals to understand how we can improve protection against TB in this high-risk group. It will involve 36 historically BCG-vaccinated participants in total; 12 healthy volunteers will receive boosting vaccination with aerosol BCG, while a further 12 healthy volunteers will receive a boosting vaccination with intradermal BCG. We will perform washings from the lungs
  bronchoscopies) 14 days after BCG vaccination to measure immunological and
  bacterial responses. A further 12 previously BCG-vaccinated healthy adult volunteers with Type 2 Diabetes will receive a boosting vaccination with intradermal BCG. We will take blood samples from all volunteers to explore the immune response to BCG and develop markers to understand who has developed a protective immune response to TB.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  23/SC/0371

• Date of REC Opinion

  19 Dec 2023

• REC opinion

  Further Information Favourable Opinion