TABLE 3 Evidence Table: Controlled Epidemiological Studies—Vaccines and Type 1 Diabetes

Citation

Design

Population

Exposure Measure

Outcome Measure

Results

Comment

Contribution to Causality Argument

DeStefano et al. (2001)

Case- control

252 children from 4 HMOs that participate in Vaccine Safety Datalink project of the CDC along with their 768 matched controls (United States)

From chart review: vaccine exposure prior to diabetes incidence date: DTaP, DTwP, measles-mumps-rubella, varicella; Hib, HepB;

Timing of Hep B (never vaccinated; birth to 4 days, 15 to 55 days, and GTE 56 days); Hib schedule (3 doses in first 8 mos + 4th dose at 12–18 mos vs. 1 dose at 21–27 months)

Cases in HMO registries with ICD-9 diagnosis of type 1 diabetes

Adjusted OR (95% CI):

Vaccines and Type I diabetes

Hep B = 0.73 (0.45-1.19)

Hib = 1.23 (0.53-2.89)

whole-cell pertussis = 0.23 (0.06-0.93)

acellular pertussis = 1.12 (0.63-1.99)

MMR = 1.43 (0.71-2.86)

Varicella = 1.02 (0.61- 1.71)

Hep B timing and risk of type 1 diabetes

0–14 d = 0.66 (0.27-1.59)

15–55 d = 0.65 (0.21-2.0)

=56 d = 0.74 (0.45-1.21)

Hib schedule and risk of type 1 diabetes:

1 dose only at 21–27 mo: 0.45 (0.15-1.30)

Other schedules = 0.71 (0.41-1.24)

Not vaccinated = 0.64 (0.22-1.81)

Limited ability in comparing Hib schedules since only a few children received no Hib or only 1 dose at 21–27 months

Weak evidence relevant to causality. Favors no effect of specific vaccine or the timing of Hepatitis B and Hib.

EURODIAB Study Group (2000)

Case- control

900 cases with diabetes and 2302 controls matched on age

Vaccination history by interview or questionnaire; Vaccines included BCG, polio,

Diabetes cases from a population-based register

Adjusted OR (95% CI)

BCG = 0.83 (0.57-1.20)

Polio = 1.20 (0.57-2.52)

Tetanus = 1.56 (0.73-3.33)

Ascertainment bias

Weak evidence relevant to causality;

Favors no effect



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