CpG辅助乙型肝炎疫苗（HEPLISAV-B®）更新

StephenW

CpG-Adjuvanted Hepatitis B Vaccine (HEPLISAV-B®) Update
Guan-Huei Lee  1   2 , Seng-Gee Lim  1   2
Affiliations
Affiliations

    1
    Division of Gastroenterology and Hepatology, Department of Medicine, National University Hospital, Singapore, 117597, Singapore.
    2
    Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, 117597, Singapore.

    PMID: 33783302 DOI: 10.1080/14760584.2021.1908133

Abstract

HEPLISAV-B is a hepatitis B vaccine composed of rHBsAg mixed with a synthetic oligonucleotide containing CpG motifs that stimulate innate immunity through TLR9. This vaccine was recently approved by the FDA in view of its superior efficacy.Areas covered: Published literature on HEPLISAV-B was critically reviewed. Four randomized controlled trials among 7,056 subjects receiving 2 doses of HEPLISAV-B and 3,214 subjects receiving 3 doses of Engerix-B showed superior seroprotection rate (SPR) (anti-HBs ≥10 mIU/mL) of 90 - 100%, compared with 71 - 90% in those receiving Engerix-B. Furthermore, the seroprotection rate was also significantly higher in HEPLISAV-B compared with Engerix-B recipients in persons with traditionally poor vaccine response such as older adults, diabetics and those with chronic kidney disease. The safety profiles among 9,871 subjects were similar between HEPLISAV-B and Engerix-B .Expert opinion: HEPLISAV-B, a CpG adjuvant mixed with HBsAg, is more efficacious and produced earlier seroprotection compared to existing vaccines, with a favourable safety profile. The shorter, two-dose regimen, earlier seroprotection, higher adherence and a higher seroprotection rate, especially in populations with traditionally poor vaccine response, makes this an important therapeutic option in hepatitis B vaccination.

Keywords: Anti-HBsAg antibody; CpG adjuvant; Engerix-B; Hepatitis B virus; Injection site reaction; Poor responder; Recombinant vaccine; Sci-B-Vac; Seroprotection rate; TLR9.

StephenW

CpG辅助乙型肝炎疫苗（HEPLISAV-B®）更新
李冠辉1 2，林圣基1 2
隶属关系
隶属关系

    1个
    新加坡国立大学医院，消化科和肝病科，新加坡，117597。
    2个
    新加坡国立大学Yong Loo Lin医学院医学系，新加坡117597。

    PMID：33783302 DOI：10.1080 / 14760584.2021.1908133

抽象的

HEPLISAV-B是由rHBsAg与合成的寡核苷酸组成的乙型肝炎疫苗，该寡核苷酸含有CpG模体，可通过TLR9刺激先天免疫。鉴于其优越的功效，该疫苗最近获得了FDA的批准。涉及的领域：严格审查了有关HEPLISAV-B的已发表文献。在接受2剂HEPLISAV-B的7,056名受试者和接受3剂Engerix-B的3,214名受试者中的四项随机对照试验显示，其优越的血清保护率（SPR）（抗HBs≥10mIU / mL）为90-100％，而71 -接受Engerix-B的患者占90％。此外，在疫苗反应传统较差的人群（例如老年人，糖尿病患者和慢性肾脏病患者）中，HEPLISAV-B的血清保护率也比Engerix-B接受者高。 HEPLISAV-B和Engerix-B之间的9,871名受试者的安全性特征相似。专家意见：HEPLISAV-B是一种与HBsAg混合的CpG佐剂，与现有疫苗相比，它更有效，并且产生了更早的血清保护，具有良好的安全性。较短的两剂方案，更早的血清保护，更高的依从性和更高的血清保护率，尤其是在传统上疫苗反应较差的人群中，使其成为乙型肝炎疫苗接种的重要治疗选择。

关键词：抗HBsAg抗体； CpG佐剂； Engerix-B;乙型肝炎病毒;注射部位反应；反应不佳；重组疫苗； Sci-B-Vac；血清保护率； TLR9。