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http://hdl.handle.net/1942/35385
Title: | Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders: Double-blinded, randomised, controlled phase 2 trial | Authors: | KOC, Ozgur de Smedt , P KREMER, Cécile ROBAEYS, Geert van Damme , P HENS, Niel Almeida, J Falkenberg, F Savelkoul, P Lashof, AO |
Issue Date: | 2021 | Publisher: | WILEY | Source: | Liver international (Print), 41 (10) , p. 2318-2327 | Abstract: | Background & Aims Approximately 5%-10% of the general population respond inadequately to licensed recombinant hepatitis B vaccines. We assessed the immunogenicity and safety of a new HBAI20 vaccine, consisting of a new AI20 adjuvant (20-mu g recombinant human IL-2 attached to 20-mu g aluminium hydroxide) in combination with HBVaxPro (R)-10 mu g.Methods In a double-blinded, randomised, controlled phase 2 trial, 18- to 59-year-old healthy non-responders (titre <10 mIU/ml after three or more doses of hepatitis B vaccine) were assigned (3:1 ratio) to receive either HBAI20 vaccine or HBVaxPro (R)-10 mu g in a 0, 1 and 2-month schedule. The primary outcome was seroprotection (titre >= 10 mIU/ml) measured 1-3 months following the third vaccination.Results A total of 133 participants were randomised to receive either HBAI20 vaccine (n = 101) or HBVaxPro (R)-10 mu g (n = 32). In the modified intention-to-treat analysis, the seroprotection rate after the third vaccination was 92.0% (80/87) in the HBAI20 group and 79.3% (23/29) in the HBVaxPro (R)-10-mu g group, P = .068. Using a generalised linear mixed model to adjust for stratification factors, a higher odds of seroprotection with HBAI20 vaccine was shown (adjusted odds ratio = 3.48, P = .028). Frequency of mild and moderate local adverse events was greater in the HBAI20 group than in the HBVaxPro (R)-10 mu g. Rates of severe local adverse events and systemic adverse events were low and similar in both groups.Conclusions In this group of hepatitis B vaccine non-responders, the HBAI20 vaccine demonstrated a higher seroprotection rate when adjusting for stratification factors and a similar safety profile compared to the licensed recombinant HBVaxPro (R)-10 mu g. | Keywords: | adjuvant;HBAI20;hepatitis B vaccine;immunogenicity;non‐responder | Document URI: | http://hdl.handle.net/1942/35385 | ISSN: | 1478-3223 | e-ISSN: | 1478-3231 | DOI: | 10.1111/liv.14939 | ISI #: | 000653189200001 | Rights: | 2021 The Authors. Liver International published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2022 |
Appears in Collections: | Research publications |
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