@article{dd2396f0ed004453a2d1a9732c8063da,
title = "Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders: Double-blinded, randomised, controlled phase 2 trial",
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-µg recombinant human IL-2 attached to 20-µg aluminium hydroxide) in combination with HBVaxPro{\textregistered}-10 µg. 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{\textregistered}-10 µg 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{\textregistered}-10 µg (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{\textregistered}-10-µg 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{\textregistered}-10 µg. 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{\textregistered}-10 µg.",
keywords = "HBAI20, adjuvant, hepatitis B vaccine, immunogenicity, non-responder",
author = "Koc, \{{\"O}zg{\"u}r M.\} and \{de Smedt\}, Philippe and Kremer, \{C. cile\} and Geert Robaeys and \{van Damme\}, Pierre and Niel Hens and Jorge Almeida and Frank Falkenberg and Paul Savelkoul and \{Oude Lashof\}, Astrid and Monique Rutten and \{de Schryver\}, Antoon and Marienoelle Schmickler and Annemie Cattrysse and Vincent Moermans and Christel Schabon and \{van der Krans\}, Hans and \{the BE RESPONDER Study Group\} and Jana Kalenda",
note = "Funding Information: The study was partially sponsored by CyTuVax BV, and the sponsor was involved in the study design, interpretation of the data, review and approval of the manuscript in accordance with good clinical practice. The funding source had no input in data collection and statistical analysis of the data. ?K, CK, NH and AOL had full access to all the data in the study and the corresponding author had final responsibility for the decision to submit for publication. CyTuVax BV sponsored the study. The authors would like to thank the many participants and would like to acknowledge Mohannad Altabban (CyTuVax BV, Maastricht, the Netherlands), the staffs of the Ease Travel Clinic \& Health Support (Maastricht, the Netherlands), the Department of Gastroenterology and Hepatology (Genk, Belgium) and Centre for the Evaluation of Vaccination, Vaccine \& Infectious Disease Institute (Antwerp, Belgium) for their careful performance of the study. Funding Information: {\"O}MK received travel grants from Gilead Sciences and his institution received grants from Gilead Sciences, AbbVie, MSD and CyTuVax BV GR has received research grants from AbbVie, MSD, Janssen Pharmaceuticals, and has acted as a consultant/advisor for AbbVie, MSD, Gilead Sciences and Bristol‐Myers Squibb. PVD acts as chief and principal investigator for vaccine trials conducted on behalf of the University of Antwerp, for which the University obtains research grants from vaccine manufacturers; speakers fees for presentations on vaccines are paid directly to an educational fund held by the University of Antwerp. PVD receives no personal remuneration for this work. JA is an employee of CyTuVax BV FF is inventor of the use of cytokine macro‐aggregates as adjuvant and is co‐founder and shareholder of CyTuVax BV AOL received honorarium for lectures from GSK and Janssen‐Cilag, all payments were invoiced by the Department of Medical Microbiology, Maastricht UMC+. NH is holder of the chair in evidence‐based vaccinology supported though a gift by Pfizer. All outside the submitted work. The following authors reported that they have no conflicts of interest: CK, PDS and PS. Publisher Copyright: {\textcopyright} 2021 The Authors. Liver International published by John Wiley \& Sons Ltd Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
month = oct,
day = "1",
doi = "10.1111/liv.14939",
language = "English",
volume = "41",
pages = "2318--2327",
journal = "Liver international",
issn = "1478-3223",
publisher = "Wiley Blackwell",
number = "10",
}
SDG 3 Good Health and Well-being