But vaccine still recommended for diabetes patients due to increased risk of disease…
Information presented at the Annual Conference on Vaccine Research states there is no statistical evidence that type 2 diabetes affects the hepatitis B vaccine (HBV). The committee also added that patients aged 19 to 59 who are diagnosed with diabetes should receive the HBV vaccine, and patients over the age of 60 may receive the vaccine under the physician’s discretion. Though there are limited data on the effects of the HBV vaccination, the recommendations were made on the premise that patients with diabetes are at increased risk for HBV.
In a phase 4, open-label, international trial, Andrew Trofa and colleagues assessed the seroprotection from 512 participants with no history of HBV infection with three doses of HBV vaccine. The study included adult men and women with type 2 diabetes and 256 controls without diabetes divided into subgroups by age (20-39 years, 40-49 years, and 60 years or older) and BMI (/= 30). Researchers also measured the geometric mean concentration (GMC) of HB antigen at month 7 — 1 month after the vaccine series. At least 10 mlU/mL of surface hepatitis B antigen detection was required to be seroprotection.
The results showed the seroprotection rate at month 7 was 75.4% for diabetes participants, and 82% for controls, a 6.6% difference. The CI suggested no statistical difference between the groups. GMC, however, showed a difference among the groups. Safety profile showed 22 adverse events in the diabetic group as opposed to 11 in the control group. In this study, age had a negative effect on the immune response. Patients aged 50 to 59 years had a seroprotection rate of 83.2% and 82.3%, and decreased to 58.2% and 70.2 for those 60 years or older in the diabetics and control groups, respectively. Male gender, BMI, and diabetes showed lower seroprotection in a multivariable and stepwise regression analyses with respect to age. Limitations of the study included gender imbalance, few African-American participants, and smoking factor was not included in the study.
The researchers concluded that the HBV vaccine should be administered in patients with diabetes for patients 59 or younger, which supports ACIP’s recommendation.
- The study concluded that the HBV vaccine should be administered in patients with diabetes for patients 59 or younger.
- Patients over the age of 60 may receive the vaccine under the physician’s discretion.
- ACIP’s recommendation also supports these findings.
Trofa A, et al. Abstract S9. Presented at: Annual Conference on Vaccine Research; April 13-15, 2015; Bethesda, Maryland.