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Effect of Bacillus Calmette-Guerin vaccination on new-onset type 1 diabetes. A randomized clinical study
H F Allen1, G J Klingensmith, P Jensen
1Baystate Medical Center Children's Hospital, Springfield, MA 01095, USA. holley.allen@bhs.org
Insights
The Bacillus Calmette-Guerin (BCG) vaccine did not improve remission rates or preserve beta-cell function in children with new-onset type 1 diabetes. This randomized trial showed no significant differences between BCG and placebo groups over two years.
Area of Science:
- Immunology
- Endocrinology
- Pediatrics
Background:
- Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction of insulin-producing beta cells.
- Preserving residual beta-cell function is a key goal in managing new-onset T1D to improve glycemic control and reduce complications.
- The Bacillus Calmette-Guerin (BCG) vaccine has immunomodulatory effects that have been investigated for potential therapeutic benefits in various autoimmune conditions.
Purpose of the Study:
- To evaluate the efficacy of the BCG vaccine in preserving beta-cell function in children diagnosed with new-onset type 1 diabetes.
- To determine if BCG vaccination can increase the rate of clinical remission, defined as insulin independence, in this pediatric population.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 94 children (aged 5-18 years) with new-onset type 1 diabetes.
- Participants received either intradermal BCG vaccine or saline placebo within four months of symptom onset.
- Outcomes were assessed every three months for two years, focusing on remission, C-peptide levels, insulin dose, and HbA1c.
Main Results:
- One patient in each group achieved remission (insulin independence for 4 weeks).
- Fasting and stimulated C-peptide levels, indicators of beta-cell function, did not differ between the BCG and placebo groups and declined over time.
- No significant differences were observed in insulin requirements or HbA1c levels between the treatment arms.
Conclusions:
- BCG vaccination administered at the time of new-onset type 1 diabetes does not enhance beta-cell function.
- The study found no evidence that BCG vaccination increases the remission rate in children with type 1 diabetes.
- These findings suggest BCG is not an effective intervention for preserving beta-cell function or achieving remission in new-onset pediatric type 1 diabetes.
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.
Research Design And 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.