鼻用治疗性疫苗（NASVAC，含有 HBsAg 和 HBcAg）对慢性乙型肝炎

StephenW

鼻用治疗性疫苗（NASVAC，含有 HBsAg 和 HBcAg）对慢性乙型肝炎患者的持续抗病毒和肝脏保护：III 期临床试验的 2 年随访
Sheikh Mohammad Fazle Akbar 1，Mamun Al Mahtab 2，Julio Cesar Aguilar 3，Osamu Yoshida 1，Eduardo Penton 3，Guillen Nieto Gerardo 3，Yoichi Hiasa 1
隶属关系
隶属关系

    1
    日本爱媛大学医学研究生院胃肠病学和代谢学系，爱媛 791-0295。
    2
    Bangabandhu Sheikh Mujib 医科大学肝脏病学系，BSMMU，达卡 1000，孟加拉国。
    3
    基因工程和生物技术中心，古巴哈瓦那 10600。

    PMID：34832596 DOI：10.3390/病原体10111440

抽象的

一项针对初治慢性乙型肝炎 (CHB) 患者的 III 期临床试验揭示了一种同时含有乙型肝炎表面抗原 (HBsAg) 和乙型肝炎核心抗原 (HBcAg) (NASVAC) 的疫苗的安全性和相当大的治疗效果治疗 (EOT) 和 EOT 后 24 周。 EOT 两年后，我们检查了 HBV DNA、丙氨酸氨基转移酶 (ALT) 和乙型肝炎 e 抗原 (HBeAg)。数据显示，在 EOT 两年后，66 名接受 NASVAC 的 CHB 患者中有 33 名血液中的 HBV DNA 呈阴性。 37 名患者的 ALT 水平在正常上限 (ULN) 内，尽管所有 66 名 CHB 患者在治疗开始前都升高了 ALT（高于 ULN）。在总共 12 名 HBeAg 阳性患者中，有 8 名患者的 HBeAg 呈阴性。在此期间，没有患者出现肝硬化。 NASVAC 是一种有限的治疗方案，具有持续的抗病毒和肝脏保护特性。本研究首次报道了慢乙肝免疫治疗的随访数据。 NASVAC 是一种持续时间有限的免疫疗法，对 CHB 患者具有持续的抗病毒和肝脏保护特性。

关键词：HBsAg/HBcAg疫苗； NASVAC；慢性乙型肝炎;鼻疫苗；持续影响；治疗性疫苗。
拨款支持

    授权号 20fk0310103h1904/日本医学研究与开发机构 (AMED)

StephenW

  Sustained Antiviral and Liver Protection by a Nasal Therapeutic Vaccine (NASVAC, Containing Both HBsAg and HBcAg) in Patients with Chronic Hepatitis B: 2-Year Follow-Up of Phase III Clinical Trial
Sheikh Mohammad Fazle Akbar  1 , Mamun Al Mahtab  2 , Julio Cesar Aguilar  3 , Osamu Yoshida  1 , Eduardo Penton  3 , Guillen Nieto Gerardo  3 , Yoichi Hiasa  1
Affiliations
Affiliations

    1
    Department of Gastroenterology and Metabology, Graduate School of Medicine, Ehime University, Ehime 791-0295, Japan.
    2
    Department of Hepatology, Bangabandhu Sheikh Mujib Medical University, BSMMU, Dhaka 1000, Bangladesh.
    3
    Center for Genetic Engineering and Biotechnology, Havana 10600, Cuba.

    PMID: 34832596 DOI: 10.3390/pathogens10111440

Abstract

A phase III clinical trial in treatment-naïve patients with chronic hepatitis B (CHB) revealed the safety and considerable therapeutic efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (NASVAC) at the end of treatment (EOT) and 24 weeks after EOT. Two years after EOT, we checked HBV DNA, alanine aminotransferase (ALT), and hepatitis B e antigen (HBeAg). The data reveal that 33 of 66 NASVAC-recipient CHB patients became negative for HBV DNA in the blood two years after EOT. The ALT levels were within the upper limit of normal (ULN) in 37 patients, although all 66 CHB patients had elevated ALT (above ULN) before the start of therapy. Out of the total twelve HBeAg-positive patients, eight patients became negative for HBeAg. None of the patients developed cirrhosis of the liver within this period. NASVAC is a finite treatment regimen with sustained antiviral and liver-protecting properties. This study is the first to report follow-up data of immune therapy for CHB. NASVAC, an immune therapy of finite duration, is endowed with sustained antiviral and liver protection properties in CHB patients.

Keywords: HBsAg/HBcAg vaccine; NASVAC; chronic hepatitis B; nasal vaccine; sustained effects; therapeutic vaccine.
Grant support

    Grant number 20fk0310103h1904/Japan Agency for Medical Research and Development (AMED)

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