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http://hdl.handle.net/1942/28499
Title: | Safety and immunogenicity of HBAI20 Hepatitis B vaccine in healthy naive and nonresponding adults | Authors: | KOC, Ozgur Savelkoul, P. H. M. Van Loo, I. H. M. Peeters, Adele Lashof, A. M. L. Oude |
Issue Date: | 2018 | Publisher: | WILEY | Source: | JOURNAL OF VIRAL HEPATITIS, 25(9), p. 1048-1056 | Abstract: | Approximately 5% of the healthy adult population respond inadequately to the commercial recombinant hepatitis B vaccines. As the recombinant vaccines all have an aluminium-based adjuvant, we tried to enhance the immune response by adding a cytokine-based adjuvant. This new adjuvant AI20, containing 20g recombinant human IL-2 attached to 20g aluminium hydroxide, was added to HBVaxPro (c)-10g (HBAI20). In a double-blind randomized controlled trial (RCT), 24 naive subjects were randomized to receive either HBAI20 or commercial HBVaxPro (c)-10g vaccine. In an open-label study, 10 nonresponders received HBAI20 vaccine. All participants received 3 vaccinations (0, 1 and 6months). In the RCT, the occurrence of any adverse events or severe events was similar between the trial arms. At month 7, all naive participants were seroprotected; moreover, 92% in the HBAI20 group had protective antibodies 10days after the second vaccination vs 58% in the HBVaxPro (c)-10g group, P=.16. In the open-label study, no serious adverse events were noted. The HBAI20 vaccine was able to elicit protective anti-HBs titres in 90% of nonresponders, 1month after the third vaccination. According to these results, the new HBAI20 vaccine seems safe, well-tolerated and may promote more rapid protection against hepatitis B infection. | Notes: | [Koc, O. M.; Savelkoul, P. H. M.; van Loo, I. H. M.; Lashof, A. M. L. Oude] Maastricht Univ, Med Ctr, Sch NUTRIM, Dept Med Microbiol, Maastricht, Netherlands. [Koc, O. M.] Ziekenhuis Oost Limburg, Dept Gastroenterol & Hepatol, Genk, Belgium. [Koc, O. M.] Hasselt Univ, Fac Med & Life Sci, Hasselt, Belgium. [Savelkoul, P. H. M.] Vrije Univ Amsterdam Med Ctr, Dept Med Microbiol & Infect Control, Amsterdam, Netherlands. [Peeters, A.] Maastricht Univ, Med Ctr, Dept Clin Epidemiol & Med Technol Assessment, Maastricht, Netherlands. | Keywords: | adjuvant; HBAI20; Hepatitis B; immunogenicity; nonresponder; safety; vaccine;adjuvant; HBAI20; Hepatitis B; immunogenicity; nonresponder; safety; vaccine | Document URI: | http://hdl.handle.net/1942/28499 | ISSN: | 1352-0504 | e-ISSN: | 1365-2893 | DOI: | 10.1111/jvh.12909 | ISI #: | 000442991000006 | Rights: | 2018 The Authors. Journal of Viral Hepatitis Published by John Wiley & Sons Ltd | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2019 |
Appears in Collections: | Research publications |
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