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Clinical Trial
. 2023 May 11;41(20):3224-3232.
doi: 10.1016/j.vaccine.2023.04.028. Epub 2023 Apr 19.

Long-term immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) compared with HepB-Eng (Engerix-B) in adults with chronic kidney disease

Matthias Girndt  1 , Patricia Houser  2 , Roberto Manllo-Karim  3 , John E Ervin  4 , Chaim Charytan  5 , Stephen Chow  6 , Margarita Symonian-Silver  7 , Lawrence Lehrner  8 , Douglas Linfert  9 , Douglas Shemin  10 , Ann Michelsen  11 , Fang Xie  12 , Robert S Janssen  13
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Free article
Clinical Trial

Long-term immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) compared with HepB-Eng (Engerix-B) in adults with chronic kidney disease

Matthias Girndt et al. Vaccine. .
Free article

Abstract

Background: Hepatitis B virus (HBV) infection remains a significant global burden, especially for patients with chronic kidney disease (CKD) receiving hemodialysis. Three doses of HepB-CpG (HEPLISAV-B® vaccine) induced a superior immune response compared with 4 double doses of HepB-Eng (Engerix-B®) in a phase 3 trial (HBV-17) in adults with CKD. Here we report the long-term immunogenicity and safety of HepB-CpG and HepB-Eng in eligible participants of HBV-17 who enrolled in this optional 34-month follow-up trial (HBV-19).

Methods: HBV-19 is a multicenter, open-label, phase 3b trial of adults with CKD who previously received a complete series of HepB-CpG or HepB-Eng in the HBV-17 trial. Participants were assigned to seroprotection categories at enrollment on the basis of their antibody response to hepatitis B surface antigen (anti-HBs) in HBV-17. The objective was to evaluate the durability of seroprotection (defined as an anti-HBs concentration ≥ 10mIU/mL) induced by HepB-CpG and HepB-Eng. Participants whose anti-HBs concentration was below 10mIU/mL received additional HepB-CpG or HepB-Eng doses.

Results: 147 participants were enrolled; 66.7 % were men, median age was 65.0 years, and 83.7 % were white. The durability of seroprotection in participants with CKD was similar in those who received HepB-CpG and those who received HepB-Eng. Antibody concentrations ≥ 100mIU/mL persisted for longer in HepB-CpG than HepB-Eng recipients, among those with anti-HBs ≥ 100mIU/mL post vaccination. The geometric mean anti-HBs concentration in the HepB-CpG group was significantly higher than in the HepB-Eng group over time (P ≤ 0.0001). The safety profiles were similar between the vaccine groups.

Conclusions: Due to the higher antibody levels induced by HepB-CpG in participants with CKD, seroprotection against HBV may be expected to persist longer than that induced by HepB-Eng.

Clinicaltrials: gov: NCT01282762.

Keywords: Booster; Chronic kidney disease; HepB-CpG vaccine; Hepatitis B virus; Long-term follow-up.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: M.G. received speaker's honoraria from Astellas, Daiichi Sankyo, Novartis, Sanofi, Vifor, and GlaxoSmithKline unrelated to the topic of this work. F.X. is a consultant for and R.S.J. is an employee of Dynavax Technologies Corporation. No other conflicts were reported.

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