The Non-Significant Benefit of BCG Vaccination for the Treatment of Iranian Patients with Type 1 Diabetes up to 48 Weeks: A Controversial Result.

Background:There has been considerable interest in target immunotherapy in patients with diabetes. This study was designed to identify the effect of BCG vaccination in the treatment of Iranian patients with longstanding diabetes mellitus type 1. Methods: After approval of the cross-sectional study protocol by the ethics committee under number IRCT2017042919940N2, a total of 19 Iranian volunteers with diabetes mellitus type 1 completed this 48-month study. These patients received three 0.1 ml intradermal injections of BCG vaccination in weeks 0, 4 and 24. The serum level of glucose, HgbA1C and c-peptide was measured before and serially after the interventions. Insulin requirements were recorded for each patient in different weeks as the mean and standard deviation. Results: This study showed a decrease in the blood sugar level of 171.15±75.54 mg/dL in baseline to 133.77±76.97 mg/dL in 12 weeks after the first dose of BCG vaccination in these patients. There was no significant change in the mean± SD of serum blood sugar, HgbA1C and c-peptide after BCG vaccination in the baseline and week 48. Conclusion: Our results showed that small doses of BCG vaccination were not effective in long-term treatment of Iranian patients with diabetes mellitus type 1 up to 48 weeks.