Hepatitis B vaccine shows promise in patients on hemodialysis
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Four doses of a hepatitis B virus vaccine conferred seroprotection in almost 90% of patients on hemodialysis and established high antibody levels in the study population, researchers reported.
The study results, which were presented at the National Foundation for Infectious Diseases’ Annual Conference on Vaccinology Research, also identified no safety concerns among patients who received the vaccine, HEPLISAV-B, which has been approved for adults in the United States since 2017.
“People on hemodialysis don’t respond as well to standard vaccine regimens,” Robert Janssen, MD, chief medical officer at Dynavax Technologies Corporation, told Healio. “In this investigational regimen, what these results suggest is that HEPLISAV-B has the potential to provide earlier seroprotection than other vaccine regimens, the potential to provide protection for most patients on hemodialysis and, because of the high concentrations of antibodies induced by HELPISAV-B, the regimen also has the potential to offer longer duration of protection against hepatitis B.”
Janssen and colleagues conducted an open-label, single-arm, multicenter study of 119 adults aged 18 years and older who initiated or were undergoing hemodialysis and who had not previously received an HBV vaccine. Patients received vaccine doses at 0, 4, 8 and 16 weeks and were followed for a median of 42 weeks. The median participant age was 59 years, 50% of patients had diabetes mellitus, 50% were Black and 66.7% were men.
At week 20 of analysis, 89.3% (95% CI, 80.1%-95.3%) of patients showed seroprotection, the researchers reported. The percentage of patients with HBV antibodies greater than or equal to 100 mlU/mL was 81.3% (95% CI, 70.7%-89.4%) and the percentage of patients with antibodies greater than or equal to 1,000mIU/mL was 56% (95% CI, 44.1%-67.5%).
Janssen said that some of the major challenges of the analysis were specific to hemodialysis patients.
“It’s very challenging to do studies [in this population] because a lot of patients end up hospitalized because of comorbidities and they’re not always able to get all of the doses in the regimen,” he said.
Approximately 28.2% of patients had injection site reactions and 24.8% experienced systemic postinjection site reactions, the researchers reported. The reactions were mild to moderate in severity. Only one serous adverse event observed was considered to be related to the vaccine. A total of 14 deaths occurred, none of which were related to the vaccine.
Perspective
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Patients on hemodialysis are indeed at increased risk for hepatitis B infection. Unfortunately, they are not very responsive to the currently available hepatitis B vaccines. This study, which was a simple, straightforward, open-label, single-arm study — they did not have a control group — of a relatively new adjuvanted hepatitis B vaccine resulted in very good responses. Antibodies to hepatitis B surface antigen were evident in 89% of the recipients.
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Awad A, et al. An open-label, single-arm study evaluating the immunogenicity and safety of the hepatitis B vaccine HEPLISAV-B in adults receiving hemodialysis. Presented at: NFID Annual Conference on Vaccinology Research; April 26-27, 2021 (virtual meeting).
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