Hf. Allen et al., Effect of Bacillus Calmette-Guerin vaccination on new-onset type 1 diabetes - A randomized clinical study, DIABET CARE, 22(10), 1999, pp. 1703-1707
OBJECTIVE - We undertook this study to test whether Bacillus Calmette-Gueri
n (BCG) vaccine preserves beta-cell function and increases the remission ra
te in children with new-onset type 1 diabetes.
RESEARCH DESIGN AND METHODS- This was a randomized double-blind placebo-con
trolled trial offered to children referred to the Barbara Davis Center for
Childhood Diabetes or the Baystate Medical Center with a diagnosis of new-o
nset type 1 diabetes. There were 94 children aged 5-18 years who received e
ither BCG or saline intradermally within 4 months of onset of symptoms and
who were then evaluated at 3-month intervals for 2 years. The primary end p
oint was remission, defined as insulin independence for 4 weeks. Secondary
end points were C-peptide levels (fasting and in response to a mixed meal c
hallenge), insulin dose, and HbA(1c).
RESULTS - Of the patients, 47 were randomized to each arm; 7 in the placebo
group and 9 in the BCG group did not complete 1 year of the study and are
not included in the analysis. One patient from each group achieved remissio
n. Fasting and stimulated C-peptide levels did not differ by treatment arm
but declined in both groups and were lower initially and during the entire
2-year period in younger children. Insulin requirements and HbA(1c) levels
did not differ in the two groups.
CONCLUSIONS - Vaccination with BCG at the time of onset of type 1 diabetes
does not increase the remission rate or preserve beta-cell function.