Infectious Disease

The hepatitis B vaccine shows promise in hemodialysis patients

April 28, 2021

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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 Vaccine Research Conference; 26.-27. April 2021 (virtual meeting).

Disclosure:
Janssen is an employee of Dynavax Technologies Corporation.

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Four doses of a hepatitis B virus vaccine conferred seroprotection in nearly 90% of hemodialysis patients and noted high levels of antibodies in the study population, researchers reported.

The study results, presented at the National Foundation for Infectious Diseases annual conference on vaccination research, also did not reveal any safety concerns in patients who received the vaccine HEPLISAV-B, which has been approved for adults in the United States since 2017.

Source: 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: NFDI Annual Vaccine Research Conference; 26.-27. April 2021 (virtual meeting).

Robert Janssen

“People on hemodialysis do not respond as well to standard vaccination schedules” Robert Janssen, MD, Chief Medical Officer at Dynavax Technologies Corporation, said Healio. “In this study scheme, these results suggest that HEPLISAV-B has the potential to provide seroprotection earlier than other vaccination regimens, protect most patients on hemodialysis, and because of the high levels of antibodies induced by HELPISAV-. B, the regimen also has the potential to provide longer duration of protection against hepatitis B. “

Janssen and colleagues conducted an open, single-arm, multicenter study of 119 adults aged 18 and over who were initiating or undergoing hemodialysis who had not previously received an HBV vaccine. Patients received vaccination doses at 0, 4, 8 and 16 weeks and were followed up for a median of 42 weeks. The mean age of the participants was 59 years, 50% of the patients had diabetes mellitus, 50% were blacks and 66.7% were men.

At week 20 of the analysis, 89.3% (95% CI, 80.1% -95.3%) of the 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 1,000 mIU / ml 56% (95% CI, 44.1% -67.5%).

Janssen said that some of the major challenges of analysis were specific to hemodialysis patients.

“It is very difficult to do studies [in this population] because many patients are hospitalized for comorbidities and cannot always receive all of the doses in the treatment plan, ”he said.

About 28.2% of the patients had injection site reactions and 24.8% had systemic injection site reactions, the researchers reported. The reactions were mild to moderate. It was believed that only one serous adverse event was vaccine-related. There were a total of 14 deaths, none of which were vaccine-related.

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William Schaffner, MD)

William Schaffner, MD

Indeed, patients on hemodialysis are at increased risk of developing hepatitis B infection. Unfortunately, they don’t respond very well to the hepatitis B vaccines currently available. That study, which was a simple, straightforward, open-label, one-arm study of a relatively new adjuvanted hepatitis B vaccine – they had no control group – got very good responses. Antibodies to hepatitis B surface antigen were seen in 89% of recipients.

William Schaffner, MD

Member of the editorial board of Infectious Disease News

Professor of Preventive Medicine and Infectious Diseases at Vanderbilt University Medical Center

Medical Director of the National Infectious Diseases Foundation

Disclosure: Schaffner does not report any relevant financial information.

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NFID annual conference on vaccination research

NFID annual conference on vaccination research

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