ABSTRACT. Objectives. To evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenzae type b, and risk of developing type 1 diabetes; and to determine whether timing of vaccination influences risk.Methods. We conducted a case-control study within 4 health maintenance organizations (HMOs) that participate in the Vaccine Safety Datalink project of the Centers for Disease Control and Prevention. Study eligibility was restricted to children who met the following criteria: 1) born during 1988 through 1997; 2) HMO member since birth; 3) continuously enrolled for first 6 months of life; and 4) at least 12 months of HMO membership before diabetes incidence date (or index date for controls) unless incidence date was before 12 months of age. All 4 HMOs maintain registries of their members who have diabetes, and we used the registries to identify potential cases of diabetes. We conducted chart reviews to verify that potential cases met the World Health Organization epidemiologic case definition for type 1 diabetes mellitus (ie, a physician's diagnosis of diabetes plus treatment with daily insulin injections). We defined the incidence date of diabetes as the first date that the child received a diagnosis of diabetes. We attempted to match 3 controls to each case. Controls had the same eligibility criteria as cases and were matched to individual cases on HMO, sex, date of birth (within 7 days), and length of health plan enrollment (up to the incidence or index date). The index date for controls was defined as the incidence date of the case to which the control was matched. Chart abstraction was performed by trained chart abstractors using standardized forms. In addition to complete vaccination histories, the chart abstraction forms for both cases and controls included information on sociodemographic characteristics, selected medical conditions, history of breastfeeding, and family medical history. We used conditional logistic regression to estimate the odds ratio (OR) of diabetes associated with vaccination, with vaccine exposure defined as before the diabetes incidence date (or index date for controls). factors that have been studied, but most studies have not found an increased risk of type 1 diabetes associated with vaccination. [1][2][3][4][5][6][7] Most of the previous studies, however, were conducted before 1990 and do not provide information on many of the currently recommended childhood vaccines.
ResultsClassen and Classen 8,9 have hypothesized that certain vaccines (eg, hepatitis B, BCG), if given at birth, can decrease the risk of developing type 1 diabetes mellitus, whereas first vaccination at 2 months of life or later can increase the risk of type 1 diabetes. The few studies reported to date, however, have evaluated vaccine exposure without regard to timing. No controlled epidemiologic studies have been published concerning timing of vaccinations and diabetes risk.Classen 8 has also hypothesized an association of Haemophilus influenzae type b (Hib) v...