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Clinical Trial
. 2023 Jun 1;41(24):3584-3588.
doi: 10.1016/j.vaccine.2023.05.010. Epub 2023 May 11.

The persistence of seroprotective levels of antibodies after vaccination with PreHevbrio, a 3-antigen hepatitis B vaccine

T Vesikari  1 , J M Langley  2 , J N Spaans  3 , I Petrov  3 , V Popovic  3 , B Yassin-Rajkumar  3 , D E Anderson  3 , F Diaz-Mitoma  4
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Free article
Clinical Trial

The persistence of seroprotective levels of antibodies after vaccination with PreHevbrio, a 3-antigen hepatitis B vaccine

T Vesikari et al. Vaccine. .
Free article

Abstract

Prevention of hepatitis B virus (HBV) infection by vaccination can potentially eliminate HBV-related diseases. PreHevbrio™/PreHevbri® is a 3-antigen (S, preS1, preS2) HBV vaccine (3A-HBV) recently licensed for adults in the US, EU and Canada. This study evaluated antibody persistence in a subset of fully vaccinated and seroprotected (anti-HBs ≥ 10 mIU/mL) Finnish participants from the phase 3 trial (PROTECT) of 3A-HBV versus single-antigen HBV vaccine (1A-HBV). 465/528 eligible subjects were enrolled (3A-HBV: 244; 1A-HBV: 221). Baseline characteristics were balanced. After 2.5 years, more 3A-HBV subjects remained seroprotected (88.1 % [95 %CI: 84.1,92.2]) versus 1A-HBV (72.4 % [95 %CI: 66.6,78.3)], p < 0.0001) and had higher mean anti-HBs [1382.9 mIU/mL (95 %CI: 1013.8,1751.9) versus 252.6 mIU/mL (95 %CI: 127.5,377.6), p < 0.0001]. In multiple variable logistic regression analysis including age, vaccine, initial vaccine response, sex and BMI, only higher post dose 3 (Day 196) antibody titers significantly reduced the odds of losing seroprotection.

Keywords: (5-10): 3-antigen; Adult; Anti-HBs; HBV; Persistence; Seroprotection.

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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: Dr Vesikari reported being the majority shareholder of Nordic Research Network Oy and to receiving grants from VBI Vaccines during the conduct of the study. Dr Popovic reported receiving personal fees from VBI Vaccines during the conduct of the study and outside the submitted work. Dr Diaz-Mitoma reported receiving personal fees from VBI Vaccines during the conduct of the study; owning shares in VBI Vaccines outside the submitted work. I. Petrov is an employee of VBI Vaccines. J. Spaans was a VBI Vaccines employee during the conduct of the study.

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