The hepatitis B vaccine was immunogenic in adults with type 2 diabetes and had a safety profile similar to that of control subjects in a manufacturer-sponsored phase-IV trial published in Human Vaccines & Immunotherapeutics.
Adults with diabetes are at twice the risk for developing acute hepatitis B infection as are nondiabetic adults, and the U.S. Advisory Committee on Immunization Practices recommends the vaccine in this patient population, said Dr. Olivier Van Der Meeren of GlaxoSmithKline, Wavre (Belgium) and his associates.
They performed a prospective study comparing the immunogenicity of the vaccine in 378 people with, and 189 without, type 2 diabetes. These participants were followed at 21 sites in Australia, Canada, New Zealand, and the United States. Control subjects were matched to diabetes patients for age and body mass index.
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One month after receiving the final of three doses of the vaccine, the seroprotection rate was 75.4% in the diabetes group and 82.0% in the control group, which was considered comparable. However, in a stepwise regression analysis, older age, higher BMI, female gender, and presence of diabetes were associated with reduced hepatitis B antibody concentrations, suggesting that the vaccine was less immunogenic in diabetic patients than in healthy controls, the investigators noted (Human Vacc Immunother. 2016 April 28. doi: 10.1080/21645515.2016.1164362).
Reactions and adverse events were deemed similar between the two study groups. Grade 3 adverse events developed in 8.4% of the diabetes group and 6.3% of the control group. Serious adverse events developed in 3.8% of the diabetes group and 1.6% of the control group, and none were considered to be related to the vaccine.
“Because increasing age was generally associated with a reduction in seroprotection rates, hepatitis B vaccine should be administered as soon as possible after the diagnosis of diabetes,” Dr. Van Der Meeren and his colleagues said.
Dr. Van Der Meeren is employed by and holds stock options for GlaxoSmithKline, which sponsored the study and was involved in its design, in collecting and analyzing the data, and in publishing the report. His associates reported ties to numerous industry sources.