Neonatal Bacille Calmette-Guerin Vaccination and Type 1 Diabetes

  1. Marceline Huppmann1,
  2. Andrea Baumgarten, DIPSOCSC1,
  3. Anette-G. Ziegler, MD1 and
  4. Ezio Bonifacio, PHD12
  1. 1Diabetes Research Institute and Academic Hospital Schwabing, Munich, Germany
  2. 2Immunology of Diabetes Unit, Istituto Scientifico San Raffaele, Milan, Italy
  1. Address correspondence and reprint requests to Dr. Ezio Bonifacio, Institut für Diabetesforschung, Kölner Platz 1, D-80804 München, Germany. E-Mail: ezio.bonifacio{at}

Type 1 diabetes is a genetic disorder that is associated with the early development of autoimmunity against islet β-cells (1). The a priori genetically determined risk for type 1 diabetes is modified by mostly unknown environmental factors that are thought to contribute to the increasing incidences of childhood diabetes in the last decade. Changes in exposure to environment are also discussed as a potential means to reduce the incidence of type 1 diabetes. Adjuvant therapy that includes vaccinations with agents such as Bacille Calmette-Guerin (BCG), for example, have been proposed as beneficial modifiers of the immune system that can reduce the incidence of autoimmune diabetes in animal models (2). In humans, there have also been sporadic reports of preserving β-cell function when BCG vaccination is administered soon after diabetes onset (3), and it has been suggested that BCG vaccination early in childhood could reduce the incidence of type 1 diabetes. Hence, there is substantial interest in whether immunostimulation with BCG could be used as a primary, secondary, or tertiary vaccination strategy for type 1 diabetes.


Vaccination with BCG in the first weeks after birth was practiced in Germany until 1998. Approximately 25% of children received vaccination, which was given as a single injection. Between 1989 and 2000, we recruited newborn children of parents with type 1 diabetes living in Germany into a prospective study (4) that examined the development of islet autoimmunity and type 1 diabetes. …

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