Effect of Bacillus Calmette-Guerin vaccination on new-onset type 1 diabetes. A randomized clinical study.
OBJECTIVE
We undertook this study to test whether Bacillus Calmette-Guerin (BCG) vaccine preserves beta-cell function and increases the remission rate in children with new-onset type 1 diabetes.


METHODS
This was a randomized double-blind placebo-controlled trial offered to children referred to the Barbara Davis Center for Childhood Diabetes or the Baystate Medical Center with a diagnosis of new-onset type 1 diabetes. There were 94 children aged 5-18 years who received either 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 point was remission, defined as insulin independence for 4 weeks. Secondary end points were C-peptide levels (fasting and in response to a mixed meal challenge), insulin dose, and HbA1c.


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 remission. 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 HbA1c 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.
Allen
H F
HF
Baystate Medical Center Children's Hospital, Springfield, MA 01095, USA. holley.allen@bhs.org
Klingensmith
G J
GJ
Jensen
P
P
Simoes
E
E
Hayward
A
A
Chase
H P
HP
D000293:Adolescent; D001323:Autoantibodies / Q000097:blood; D001500:BCG Vaccine / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D002096:C-Peptide / Q000097:blood; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D004311:Double-Blind Method; D004435:Eating; D005260:Female; D005500:Follow-Up Studies; D005968:Glutamate Decarboxylase / Q000276:immunology; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007328:Insulin / Q000627:therapeutic use; D007330:Insulin Antibodies / Q000097:blood; D007515:Islets of Langerhans / Q000276:immunology; D008297:Male; D010919:Placebos
D001323:Autoantibodies; D001500:BCG Vaccine; D001786:Blood Glucose; D002096:C-Peptide; D005968:Glutamate Decarboxylase; D006442:Glycated Hemoglobin; D007328:Insulin; D007330:Insulin Antibodies; D010919:Placebos; C024211:islet cell antibody