EFFECT OF BACILLE CALMETTE-GUERIN VACCINATION ON C-PEPTIDE SECRETION IN CHILDREN NEWLY-DIAGNOSED WITH IDDM

OBJECTIVE - To determine whether administration of bacille Calmette-Gu erin (BCG) vaccination to newly diagnosed IDDM patients can help prese rve C-peptide secretion over the subsequent 18 months. RESEARCH DESIGN AND METHODS - Twenty-six IDDM patients, all of whom had been diagnose d within the previous year, had basal C-peptide levels >0.06 nmol/l, a nd had negative reactions to Mantoux's test, were randomized pairwise as they presented and were given either 0.1 ml (100 mu g) BCG vaccine or 0.1 ml saline intradermally. Both the patients and the investigator s were blinded to the treatment. Fasting and glucagon-induced C-peptid e levels and HbA(1c) were measured in all patients at enrollment and a t 1, 3, 6, 9, 12, and 18 months after vaccination, and insulin dose wa s recorded at each visit. RESULTS - At enrollment, there was no signif icant difference in age, duration of diabetes, insulin dose, HbA(1c), or fasting C-peptide levels between the BCG-vaccinated and control gro ups. The mean basal and stimulated C-peptide levels in the BCG-treated group did not differ significantly from those in the control group at any time during the 18 months of followup, and there was no differenc e in insulin dose or HbA(1c) at any time between the groups. CONCLUSIO NS - BCG vaccination in children who have been recently diagnosed with IDDM does not affect the progressive decline in C-peptide levels or a lter the clinical course of the disease.