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Title: 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
Author(s): Girndt, MatthiasLook up in the Integrated Authority File of the German National Library
Houser, Patricia
Manllo-Karim, Roberto
Ervin, John E.
Charytan, Chaim
Chow, Stephen
Symonian-Silver, Margarita
Lehrner, Lawrence
Linfert, Douglas
Shemin, Douglas
Michelsen, Ann
Xie, Fang
Janssen, Robert S.
Issue Date: 2023
Type: Article
Language: English
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 ≥ 10 mIU/mL) induced by HepB-CpG and HepB-Eng. Participants whose anti-HBs concentration was below 10 mIU/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 ≥ 100 mIU/mL persisted for longer in HepB-CpG than HepB-Eng recipients, among those with anti-HBs ≥ 100 mIU/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. NCT01282762.
Open Access: Open access publication
License: (CC BY 4.0) Creative Commons Attribution 4.0(CC BY 4.0) Creative Commons Attribution 4.0
Journal Title: Vaccine
Publisher: Elsevier
Publisher Place: Amsterdam
Volume: 41
Issue: 20
Original Publication: 10.1016/j.vaccine.2023.04.028
Page Start: 3224
Page End: 3232
Appears in Collections:Open Access Publikationen der MLU

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