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HBV vaccine unaffected by diabetes
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BETHESDA, Md. — There is no statistical evidence that type 2 diabetes negatively affects seroprotection of hepatitis B vaccine, according to findings presented at the Annual Conference on Vaccine Research.
“This study suggests that type 2 diabetes itself does not impact hepatitis B vaccine seroprotection rates,” Andrew Trofa, MD, of GlaxoSmithKline, told Infectious Disease News. “Clinicians should follow the 2011 ACIP recommendations for hepatitis B vaccine in unvaccinated adults with diabetes mellitus.”
In 2011, the Advisory Committee on Immunization Practices recommended that patients aged 19 to 59 years should be vaccinated against HBV as soon as possible after a diagnosis of diabetes, and for those aged 60 years and older, the HBV vaccine may be administered at the clinician’s discretion. These recommendations were made primarily because patients with diabetes are at an increased risk for HBV, Trofa mentioned during his presentation. However, there are limited data from prospective clinical trials of HBV vaccination in people with diabetes, he said.
In a phase 4, open-label, international trial, Trofa and colleagues assessed the seroprotection rate of the three-dose HBV vaccine series in adult men and women with type 2 diabetes who had no history of HBV infection or vaccination. The study included 512 participants with type 2 diabetes and 256 controls without diabetes who were stratified into eight subgroups by age (20-39 years, 40-49 years, 50-59 years, and 60 years and older) and BMI (< 30 and ≥ 30). Seroprotection was defined as antibodies to hepatitis B surface antigen (anti-HBs) of at least 10 mIU/mL.
In addition, the researchers assessed and compared the geometric mean concentration (GMC) of anti-HBs at month 7 — 1 month after completing the vaccine series — as well as the reactogenicity and overall safety of the vaccine between the groups.
“As we developed this trial, we asked three key questions,” Trofa said. “One: Do adults with type 2 diabetes respond to the hepatitis B vaccine as well as those without diabetes? Two: How does the safety profile of the hepatitis B vaccine compare in people with and without diabetes? And three: What is the impact of compounding factors — and in particular, age and body mass index — on the immune response?”
In the according-to-protocol cohort (n = 567), the seroprotection rate at month 7 was 75.4% (95% CI, 70.7-79.7) among participants with diabetes and 82% (95% CI, 75.8-87.2) among controls — a difference of 6.6%, with the 95% CI crossing the zero threshold, suggesting no statistical evidence of a difference in seroprotection between groups. The researchers did observe, however, a difference in GMC between those with and without diabetes — a ratio of 0.4 (95% CI, 0.25-0.64).
The safety profile of the vaccine was comparable between groups, Trofa said, with similar frequency of reported local and general symptoms. In addition, 22 serious adverse events reported in the diabetic group vs. 11 in the control group.
Age appeared to have a negative impact on immune response in the study. For example, among participants aged 50 to 59 years, the observed seroprotection rates were 83.2% and 82.3% among those with diabetes and controls, respectively, compared with 58.2% and 70.2% among those aged 60 years or older.
Multivariate regression analysis suggested age and BMI were associated with lower seroprotection. BMI, age, male gender and diabetes were associated with a negative effect on GMC.
Trofa said the study was not a noninferiority trial, and the statistical analyses were exploratory. Other limitations included a gender imbalance between groups, and African-Americans were underrepresented in the study vs. the general population. The study also did not factor in smoking history.
However, Trofa said the findings do support the ACIP’s recommendation that HBV vaccine should be administered as soon as possible after the diagnosis of diabetes in unvaccinated adults aged 59 years or younger. – by John Schoen
Reference:
Trofa A, et al. Abstract S9. Presented at: Annual Conference on Vaccine Research; April 13-15, 2015; Bethesda, Maryland.
Disclosure: Trofa reports owning stock, stock options or bonds and is employed by GlaxoSmithKline.