使用新型药物递送装置VAX-ID TM皮内递送乙型肝炎加强疫苗的

StephenW

Vaccine. 2018 Dec 23. pii: S0264-410X(18)31676-1. doi: 10.1016/j.vaccine.2018.12.016. [Epub ahead of print]
Immunogenicity and safety of intradermal delivery of hepatitis B booster vaccine using the novel drug delivery device VAX-ID™.
Van Mulder TJS1, Withanage K2, Beyers KCL3, Vankerckhoven VVJ4, Theeten H2, Van Damme P2.
Author information

1
    Novosanis, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium; Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, BE-2610 Wilrijk, Belgium. Electronic address: [email protected].
2
    Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, BE-2610 Wilrijk, Belgium.
3
    Novosanis, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium; Voxdale, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium.
4
    Novosanis, Bijkhoevelaan 32c, BE-2110 Wijnegem, Belgium; Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, BE-2610 Wilrijk, Belgium.

Abstract
BACKGROUND:

Although intramuscular (IM) injection is still the most preferred method for vaccination, intradermal (ID) delivery may have several advantages over intramuscular and subcutaneous (SC), including an improved immune response and antigen dose sparing effect. However it is currently limited due to the difficulty in standardizing the injection technique often based on the Mantoux technique. Difficulties encountered using the Mantoux technique could be overcome by the use of alternative ID delivery systems that confer more uniform and standardized procedures. The aim of this study was to evaluate the performance of a newly developed intradermal injection device, VAX-ID™, via a proof-of-concept to assess the immunogenicity of a commercially available hepatitis B booster vaccination in healthy hepatitis B pre-immunised subjects. Additionally, device safety and tolerability was evaluated.
MATERIALS AND METHODS:

Three different routes of administration were compared over 4 groups, each receiving hepatitis B vaccine antigen: (1) standard IM injection in the deltoid region (HBVAXPRO® 10 µg/1 ml), (2) ID injection in the proximal posterior area of the forearm according to the Mantoux technique, (3) with VAX-ID™ in one forearm, or (4) with VAX-ID™ in both forearms. For ID injections 0.11 cc, of which 0.01 cc is overfill, was drawn from a vial containing HBVAXPRO® 40 µg/1 ml. Immunogenicity and safety were followed-up at day 0, 14, 30 and 210.
RESULTS:

A total of 48 subjects were included. All subjects showed an anamnestic response at 14 days post booster vaccination. Elevated titres persisted until end of follow-up at day 210. For the ID groups a 3 fold higher immune response at day 14 and day 30 was recorded compared to IM group. Local adverse events were more reported for ID compared to IM.
CONCLUSIONS:

The investigated ID injection device VAX-ID™ proves to be a good alternative to offer ID vaccination.

Copyright © 2018 Elsevier Ltd. All rights reserved.
KEYWORDS:

Booster; Device; Hepatitis B vaccine; Intradermal; Intramuscular

PMID:
    30587432
DOI:
    10.1016/j.vaccine.2018.12.016

StephenW

疫苗。 2018年12月23日.pii：S0264-410X（18）31676-1。 doi：10.1016 / j.vaccine.2018.12.016。 [提前打印]
使用新型药物递送装置VAX-ID TM皮内递送乙型肝炎加强疫苗的免疫原性和安全性。
Van Mulder TJS1，Withanage K2，Beyers KCL3，Vankerckhoven VVJ4，Theeten H2，Van Damme P2。
作者信息

1
    Novosanis，Bijkhoevelaan 32c，BE-2110 Wijnegem，Belgium;安特卫普大学疫苗和传染病研究所评估中心，校园Drie Eiken，Universiteitsplein 1，BE-2610 Wilrijk，比利时。电子地址：[email protected]。
2
    安特卫普大学疫苗和传染病研究所评估中心，校园Drie Eiken，Universiteitsplein 1，BE-2610 Wilrijk，比利时。
3
    Novosanis，Bijkhoevelaan 32c，BE-2110 Wijnegem，Belgium; Voxdale，Bijkhoevelaan 32c，BE-2110 Wijnegem，Belgium。
4
    Novosanis，Bijkhoevelaan 32c，BE-2110 Wijnegem，Belgium;安特卫普大学疫苗和传染病研究所评估中心，校园Drie Eiken，Universiteitsplein 1，BE-2610 Wilrijk，比利时。

抽象
背景：

尽管肌内（IM）注射仍然是最优选的疫苗接种方法，但皮内（ID）递送可具有优于肌内和皮下（SC）的若干优点，包括改善的免疫应答和抗原剂量节约效应。然而，由于难以通常基于Mantoux技术标准化注射技术，因此它目前受到限制。使用Mantoux技术遇到的困难可以通过使用提供更统一和标准化程序的替代ID传递系统来克服。本研究的目的是评估新开发的皮内注射装置VAX-ID™的性能，通过概念验证来评估商业上可获得的乙型肝炎加强免疫接种在健康乙型肝炎预免疫受试者中的免疫原性。 。此外，还评估了器件的安全性和耐受性。
材料和方法：

比较了4组不同的给药途径，每组接受乙型肝炎疫苗抗原：（1）三角肌区标准IM注射（HBVAXPRO®10μg/ 1ml），（2）ID注射于近端后部区域。根据Mantoux技术的前臂，（3）在一个前臂中使用VAX-ID™，或者（4）在前臂中使用VAX-ID™。对于ID注射，从含有HBVAXPRO®40μg/ 1ml的小瓶中抽取0.11cc，其中0.01cc是过量填充的。在第0,14,30和210天对免疫原性和安全性进行随访。
结果：

共包括48名受试者。所有受试者在加强免疫接种后第14天显示出记忆反应。升高的滴度持续至第210天的随访结束。对于ID组，与IM组相比，在第14天和第30天记录的免疫应答高3倍。与IM相比，ID更多地报告了局部不良事件。
结论：

被调查的ID注射装置VAX-ID™被证明是提供ID疫苗接种的良好替代品。

版权所有©2018 Elsevier Ltd.保留所有权利。
关键词：

助推器;设备;乙型肝炎疫苗;皮内;肌内

结论：
    30587432
DOI：
    10.1016 / j.vaccine.2018.12.016