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

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 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.

journal_name

J Viral Hepat

journal_title

Journal of viral hepatitis

authors

Koc ÖM,Savelkoul PHM,van Loo IHM,Peeters A,Oude Lashof AML

doi

10.1111/jvh.12909

subject

Has Abstract

pub_date

2018-09-01 00:00:00

pages

1048-1056

issue

9

eissn

1352-0504

issn

1365-2893

journal_volume

25

pub_type

杂志文章,随机对照试验

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