No abstract

Exposure to HiB immunization is associated with an increased risk of IDDM. NOD mice can be used as an animal model of vaccine induced diabetes.

Animal studies have demonstrated the timing and content of human vaccines can affect the development of diabetes. Clinical trials of new human vaccines are not designed and generally not powered to detect an effect of immunization on the development of IDDM. These animal toxicology studies indicate that the effect of vaccines on human insulin dependent diabetes needs to be examined.

A low cumulative incidence of IDDM was reported in Dutch males born in 1962 (Diabetologia 1992: 35: 139-142) compared to males born in previous or later years. The cause for the decreased risk has not been previously explained. We propose that children born in 1962 during an European smallpox epidemic may have received the smallpox vaccine in the first month of life and this may have attributed to the decreased risk of IDDM in these children. We have shown that immunization with several different vaccines starting in the first month of life prevents diabetes in NOD mice and BB rats (Autoimmunity 1996: 24: 137-145) while immunization at birth with the BCG vaccine is associated with an decreased risk of IDDM in humans (Infectious Diseases in Clinical Practice 1997: 6: 449-454). An even bigger decline in diabetes is seen in rodents and associated in humans when one compares immunization starting in the first month of life to immunization starting after 2 months, since the later has been associated with an increased risk of IDDM. Immunization studies in the past have typically followed patients for only several weeks to determine any unplanned affects on autoimmune disease. Due to the potential benefit of reducing the incidence of diabetes by 50% through age 18 we believe clinical trials are warranted to study the effect of timing of immunization on IDDM.

Abstract:Background: Previous studies demonstrated clusters of cases of IDDM occurring 24 to 48 months after immunization with the hemophilus, pertussis and combined measles mumps rubella vaccines. Data was analyzed to determine if similar clustering of cases of IDDM occurred after immunization with the hepatitis B vaccine. Methods: Data on the incidence of IDDM from hepatitis B immunized and unimmunized cohorts of children was analyzed for the presence of clusters occurring after hepatitis B immunization. Results: Data from Italy, France, and New Zealand indicated rises in the incidence of IDDM occurred between 24 to 48 months after the introduction of the hepatitis B immunization in young children. Conclusion: Several different vaccines as well as infections with natural mumps virus are followed by clusters of cases of IDDM that occur about 24 to 48 months after immunization. This suggests a similar mechanism of action, possibly the triggering of a progressive autoimmune phenomenon.