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Roggendorf, H.* ; Shouval, D.S.* ; Roggendorf, M. ; Gerken, G.*

Longterm outcome of therapeutic vaccination with a third generation Pre-S/S HBV vaccine (PreHevbrioR) of chronically HBV infected patients.

J. Pers. Med. 14:364 (2024)
Publ. Version/Full Text DOI PMC
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Several antiviral treatment regimens for chronic hepatitis B (CHB) virus infection have been shown to be effective in suppressing viral load and reducing the risk of hepatocellular injury and its complications. It has been hypothesized that high levels of circulating HBV surface antigen(s) may lead to immune tolerance against HBV and contribute to chronic carriership. Conversely, low-level HBsAg may create a window for the reconstitution of an HBV-specific immune response through vaccination and control of infection. Previous studies in non-responders to yeast-derived HBV vaccines, using a third-generation pre-S/S vaccine, have led to up to 95% anti-HBs seroconversion. This report evaluates the long-term outcome after experimental vaccination with a pre-S/S HBV vaccine intended as a therapeutic intervention in chronic HBV carriers. Four low-level HBsAg carriers (<500 IU/mL) were vaccinated three to seven times with 20 μg PreHevbrioR. Three out of four carriers eliminated HBsAg completely and seroconverted to anti-HBs. One patient seroconverted to anti-HBs but remained with a borderline HBsAg titer (10 IU/mL). Serum anti-HBs levels following repeated vaccination varied between 27 and >1000 IU/L, respectively. Long-term observation (>6 years) showed that after discontinuing NUC treatment for at least two years, HBsAg and HBV DNA remained negative with anti-HBs positive titers ranging between 80 and >1000 IU/L. Based on our preliminary observations, there is a rationale to further evaluate the role of this vaccine as a therapeutic agent.
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Publication type Article: Journal article
Document type Scientific Article
Corresponding Author
Keywords Nuc Treatment ; Chronic Hepatitis B ; Long-term Observation ; Low-level Hbsag Carriers ; Therapeutic Vaccination ; Third Generation Pre-s/s Vaccine
ISSN (print) / ISBN 2075-4426
e-ISSN 2075-4426
Journal Journal of Personalized Medicine
Quellenangaben Volume: 14, Issue: 4, Pages: , Article Number: 364 Supplement: ,
Publisher MDPI
Publishing Place Basel, Switzerland
Non-patent literature Publications
Reviewing status Peer reviewed
Institute(s) Institute of Virology (VIRO)