72 patients within 4 weeks of IDDM; mean age, 14.5 years
Intervention (): one dose of BCG with NCT 25 mg/kg; control (): NCT 25 mg/kg
Freeze-dried BCG vaccine (Berna Institute, base)
HbA1c, C-peptide, insulin dosage, and clinical remission; 1-year follow-up
No significant differences in insulin dosages or C-peptide (ng/ml) (0.8/0.9 vs. 0.93/1.0 preintervention/postintervention) and HbA1c (%) (9.7/6.9 vs. 9.8/6.4 preintervention/postintervention) level between BCG and control groups. BCG did not induce long-term clinical remission in IDDM patients.
26 patients within 1 year of IDDM; mean age, 13.1 years
Intervention (): one dose of BCG; control (): placebo
BCG vaccine (Connaught, Toronto, Ontario, Canada)
HbA1c and fasting/stimulated C-peptide, and insulin dosage; 1.5-year follow-up
HbA1c, mean basal (ng/ml) (0.81/0.33 vs. 0.90/0.51 preintervention/postintervention), and stimulated (ng/ml) (1.35/0.51 vs. 1.74/0.84 preintervention/postintervention) C-peptide level, and insulin dosage did not differ significantly between BCG and control groups ().
94 children with a diagnosis of new-onset IDDM; mean age, 10.5 years
Intervention (): one dose of BCG; control (): placebo
TICE BCG (PerImmune, Rockville, MD)
HbA1c, fasting/stimulated glucose and C-peptide, insulin dosage, and clinical remission; 2-year follow-up
No differences in HbA1c (%) (8.8/8.4 vs. 9.2/8.5 preintervention/postintervention), insulin requirement, and basal or stimulated C-peptide level between both groups. The trend toward a more rapid decrease in C-peptide level () in the BCG group ().
After year 3, BCG lowered HbA1c (%) (7.36/6.65 vs. 7.1/7.22 preintervention/postintervention between intervention and control groups) to near normal levels for the next 5 years ( at year 8). No significant return of C-peptide level in the BCG group
