Pilot BCG CHIM V1
Research type
Research Study
Full title
A feasibility study of controlled human infection with intradermal Bacillus Calmette–Guérin (BCG) injection
IRAS ID
321376
Contact name
Ben Morton
Contact email
Sponsor organisation
Liverpool School of Tropical Medicine
Clinicaltrials.gov Identifier
107136 , UKRI Strength in places funding Delivering Integrated Solutions for Human Infections
Duration of Study in the UK
0 years, 11 months, 26 days
Research summary
Tuberculosis (TB) is a disease that usually causes an infection in the lungs, it is the leading infectious killer worldwide. The only vaccine available to prevent TB is called the BCG (Bacillus Calmette–Guérin). The BCG vaccine contains a live germ similar to, but weaker than, Mycobacterium tuberculosis, the germ that causes TB.
The purpose of this study is to set up a human challenge model using BCG to understand how the body responds to this vaccine. We hope that if our human challenge model works well, in the future, it may be used to help researchers to develop new vaccines and drugs to prevent and treat TB in the future.This BCG human challenge model has previously been used safely by research teams in Oxford. We are working with the Oxford team to set up the BCG human challenge model in Liverpool. Participants will receive the UK licensed BCG vaccine, at three times the dose usually given to children. The vaccine is injected under the skin on the upper arm (intradermal injection).
In phase 1, we will enrol 10 healthy participants aged 18-50. Fourteen days after injection, we will take skin biopsy samples (punch biopsy) from the BCG site (after local anaesthetic to the area) to measure BCG growth. The aim is to show that less invasive microsamples can measure BCG growth. For phase 2, we will enrol 20 new participants. We will take repeated microsamples from the biopsy site but will not take the larger biopsy sample (punch biopsy). For both phases of the study, we take blood, urine and nasal samples. In total participants from each study phase will attend 7 visits over 5 weeks.The Oxford team have completed this process with punch biopsy samples in over 100 healthy adult volunteers, demonstrating that it was safe and well tolerated.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0373
Date of REC Opinion
18 Jan 2023
REC opinion
Further Information Favourable Opinion