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

Koc, Ö. M., Savelkoul, P. H. M., van Loo, I. H. M., Peeters, A. and Oude Lashof, A. M. L. 2018, Safety and immunogenicity of HBAI20 Hepatitis B vaccine in healthy naïve and nonresponding adults, Journal of viral hepatitis, vol. 25, no. 9, pp. 1048-1056, doi: 10.1111/jvh.12909.

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Title Safety and immunogenicity of HBAI20 Hepatitis B vaccine in healthy naïve and nonresponding adults
Author(s) Koc, Ö. M.
Savelkoul, P. H. M.
van Loo, I. H. M.
Peeters, A.ORCID iD for Peeters, A. orcid.org/0000-0003-4340-9132
Oude Lashof, A. M. L.
Journal name Journal of viral hepatitis
Volume number 25
Issue number 9
Start page 1048
End page 1056
Total pages 9
Publisher Wiley
Place of publication Chichester, Eng.
Publication date 2018-09
ISSN 1352-0504
1365-2893
Keyword(s) HBAI20
Hepatitis B
adjuvant
immunogenicity
nonresponder
safety
vaccine
Science & Technology
Life Sciences & Biomedicine
Gastroenterology & Hepatology
Infectious Diseases
Virology
CONTROLLED CLINICAL-TRIAL
CHRONIC UREMIC PATIENTS
LOW-DOSE INTERLEUKIN-2
T-CELL-ACTIVATION
RECOMBINANT INTERLEUKIN-2
DENDRITIC CELLS
SURFACE-ANTIGEN
INFLUSOME-VAC
DIFFERENTIATION
EFFICACY
Summary 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 20 μg recombinant human IL-2 attached to 20 μg aluminium hydroxide, was added to HBVaxPro©-10 μg (HBAI20). In a double-blind randomized controlled trial (RCT), 24 naïve subjects were randomized to receive either HBAI20 or commercial HBVaxPro©-10 μg vaccine. In an open-label study, 10 nonresponders received HBAI20 vaccine. All participants received 3 vaccinations (0, 1 and 6 months). In the RCT, the occurrence of any adverse events or severe events was similar between the trial arms. At month 7, all naïve participants were seroprotected; moreover, 92% in the HBAI20 group had protective antibodies 10 days after the second vaccination vs 58% in the HBVaxPro©-10 μg 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, 1 month 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.
Language eng
DOI 10.1111/jvh.12909
Field of Research 1103 Clinical Sciences
1108 Medical Microbiology
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2018, The Authors
Persistent URL http://hdl.handle.net/10536/DRO/DU:30121660

Document type: Journal Article
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