Background: Insulin-dependant diabetes mellitus (IDDM) is an autoimmun
e disease that can be altered by immune modulation, NOD mice and BE ra
ts have been used as models of spontaneous IDDM. The development of di
abetes in these animals has been altered by several different immune m
odulators using relatively high doses for the size of the animal. The
effect of pharmaceutical doses of vaccines on the development of diabe
tes in these rodents has not been adequately studied. Methods: I studi
ed the effect of administering killed human vaccines using low concent
rations and as few as 3 doses. Results: Administration of human vaccin
es to diabetic prone newborn animals starting before 2 weeks of age pr
evented the development of diabetes while administration of the pertus
sis vaccine starting at 8 weeks of life was associated with an increas
ed incidence of diabetes. Conclusions: Animal studies have demonstrate
d the timing and content of human vaccines can affect the development
of diabetes. Clinical trials of new human vaccines are not designed an
d generally not powered to detect an effect of immunization on the dev
elopment of IDDM, These animal toxicology studies indicate that the ef
fect of vaccines on human insulin dependent diabetes needs to be exami
ned,