The main objective of this trial is to determine whether repeat bacillus Calmette-Guerin (BCG) injections can benefit the immune system of patients with type 1 diabetes. The main outcome to be measured is change in HbA1c levels (average blood glucose over 3 months). This trial is being conducted in Boston, Massachusetts (US).
The details
The BCG injection is a vaccine to prevent tuberculosis (TB - disease of the lungs). Previous studies have suggested that BCG injections may improve long-term diabetes by killing off the bad white blood cells (immune cells) and restoring insulin production. Further trials are needed to confirm its benefit in type 1 diabetes.
The aim of this study is to determine whether yearly vaccinations with the BCG vaccine would improve the insulin production in patients with type 1 diabetes. HbA1c levels will be measured, as well as change in immune response based on blood tests.
Who are they looking for?
150 patients aged 18-65 will be enrolled in this trial. Patients with type 1 diabetes who are HIV negative with a normal complete blood count (CBC - used to determine overall health) will be eligible for this trial.
Patients must not have a history of TB, or previous BCG vaccination. Patients who have chronic infections or conditions that will interfere with the trials results will not be considered eligible. Patients currently treated with aspirin, antibiotics or those who are pregnant will not be eligible for this trial.
How will it work
Patients will be randomly assigned to one of two groups. Group 1 will receive 2 BCG vaccinations spaced 4 weeks apart during the first year of the trial. They will then receive 1 vaccination every year for the next 4 years.
Group 2 will receive 2 saline injections instead of the real BCG vaccine spaced 4 weeks apart during the first year of the trial. They will then receive 1 injection every year for the next 4 years.
