Safety and immunogenicity of HBAI20 Hepatitis B vaccine in healthy naive and nonresponding adults

O. M. Koc, P. H. M. Savelkoul, I. H. M. van Loo, A. Peeters, A. M. L. Oude Lashof*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

7 Citations (Web of Science)

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.

Original languageEnglish
Pages (from-to)1048-1056
Number of pages9
JournalJournal of Viral Hepatitis
Volume25
Issue number9
DOIs
Publication statusPublished - Sept 2018

Keywords

  • adjuvant
  • HBAI20
  • Hepatitis B
  • immunogenicity
  • nonresponder
  • safety
  • vaccine
  • CONTROLLED CLINICAL-TRIAL
  • CHRONIC UREMIC PATIENTS
  • LOW-DOSE INTERLEUKIN-2
  • T-CELL-ACTIVATION
  • RECOMBINANT INTERLEUKIN-2
  • DENDRITIC CELLS
  • SURFACE-ANTIGEN
  • INFLUSOME-VAC
  • DIFFERENTIATION
  • EFFICACY

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