HBAI20乙型肝炎疫苗在健康幼稚和无反应成人中的安全性和免

StephenW

J Viral Hepat. 2018 Apr 16. doi: 10.1111/jvh.12909. [Epub ahead of print]
Safety and immunogenicity of HBAI20 Hepatitis B vaccine in healthy naïve and non-responding adults.Koc ÖM1,2,3, Savelkoul PHM1,4, van Loo IHM1, Peeters A5, Oude Lashof AML1.
Author information
1Department of Medical Microbiology, School of NUTRIM Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands.2Department of Gastro-enterology and Hepatology, Ziekenhuis Oost-Limburg, Schiepse Bos 6, 3600, Genk, Belgium.3Faculty of Medicine and Life Sciences, Hasselt University, Martelarenlaan 42, 3500, Hasselt, Belgium.4Department of Medical Microbiology & Infection Control, VU University Medical Center, 1081, BT, Amsterdam, the Netherlands.5Department of Clinical Epidemiolgy and Medical Technology Assessment, Maastricht University Medical Centre, P.O. Box 5800, 6202, AZ, Maastricht, The Netherlands.

AbstractApproximately 5% of the healthy adult population respond inadequately to the commercial recombinant hepatitis B vaccines. As the recombinant vaccines all have an aluminum-based adjuvant, we tried to enhance the immune response by adding a cytokine-based adjuvant. This new adjuvant AI20, containing 20μg recombinant human IL-2 attached to 20μg aluminum hydroxide, was added to HBVaxPro©-10μg (HBAI20). In a double-blind randomized controlled trial (RCT), 24 naïve subjects were randomized to receive either HBAI20 or commercial HBVaxPro©-10μg vaccine. In an open-label study, 10 non-responders received HBAI20 vaccine. All participants received three vaccinations (0, one and six 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 versus 58% in the HBVaxPro©-10μg group, p=0.16. 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 non-responders, one 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. This article is protected by copyright. All rights reserved.


KEYWORDS: Adjuvant; HBAI20; Hepatitis B; Immunogenicity; Non-responder; Safety; Vaccine

PMID:29660190DOI:10.1111/jvh.12909

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StephenW

J Viral Hepat。 2018年4月16日，doi：10.1111 / jvh.12909。 [电子版提前打印]
HBAI20乙型肝炎疫苗在健康幼稚和无反应成人中的安全性和免疫原性。
KocÖM1,2,3，Savelkoul PHM1,4，van Loo IHM1，Peeters A5，Oude Lashof AML1。
作者信息

1
    NUTRIM马斯特里赫特大学医学中心医学微生物学系，P.O. Box 5800，6202 AZ，荷兰马斯特里赫特。
2
    胃肠病学和肝病学系，Ziekenhuis Oost-Limburg，Schiepse Bos 6,3600，Genk，比利时。
3
    哈瑟尔特大学医学和生命科学系，Martelarenlaan 42,3500，比利时哈瑟尔特。
4
    荷兰阿姆斯特丹1081大学医学中心医学微生物与感染控制系。
五
    马斯特里赫特大学医学中心临床流行病学和医学技术评估部Box 5800,6202，AZ，马斯特里赫特，荷兰。

抽象

大约5％的健康成年人对商业化重组乙肝疫苗反应不足。由于重组疫苗都含有铝基佐剂，我们试图通过添加基于细胞因子的佐剂来增强免疫应答。将含有20μg与20μg氢氧化铝连接的20μg重组人IL-2的新型佐剂AI20加入到HBVaxPro±10μg（HBAI20）中。在一项双盲随机对照试验（RCT）中，24名天真的受试者被随机分配接受HBAI20或商业HBVaxPro？-10μg疫苗。在一项开放标签研究中，10名无反应者接受了HBAI20疫苗。所有参与者接受了三次疫苗接种（0,1和6个月）。在RCT中，试验组之间发生任何不良事件或严重事件相似。在第7个月，所有天真的参与者都被血清保护，而且在第二次接种后10天HBAI20组中有92％具有保护性抗体，而HBVaxPro±10μg组中有58％具有保护性抗体，p = 0.16。在开放标签研究中，没有发现严重的不良事件。在第三次接种后一个月，HBAI20疫苗能够在90％的非应答者中引发保护性抗-HBs效价。根据这些结果，新的HBAI20疫苗似乎是安全的，耐受性良好，并且可以促进更快地防止乙型肝炎感染。本文受版权保护。版权所有。
关键词：

辅助; HBAI20;乙型肝炎;免疫原性;无反应者;安全;疫苗

结论：
    29660190
DOI：
    10.1111 / jvh.12909