慢性乙型肝炎治疗性疫苗的安全性和有效性：III期临床试验

StephenW

慢性乙型肝炎治疗性疫苗的安全性和有效性：III期临床试验的后续研究
Sheikh Mohammad Fazle Akbar 1 , Mamun Al Mahtab 2 , Julio Cesar Aguilar 3 , Osamu Yoshida 1 , Sakirul Khan 4 , Eduardo Penton 3 , Guillen Nieto Gerardo 3 , Yoichi Hiasa 1
隶属关系
隶属关系

    1
    爱媛大学医学研究生院胃肠病学和代谢学系，日本 Toon 791-0295。
    2
    Bangabandhu Sheikh Mujib Medical University (BSMMU) 肝病学系，孟加拉国达卡 1000。
    3
    遗传工程和生物技术中心，古巴哈瓦那 10600。
    4
    大分大学医学院微生物学系，日本大分 879-5593。

    PMID: 35062707 DOI: 10.3390/vaccines10010045

抽象的

本研究的目的是评估含有 HBsAg 和 HBcAg 的治疗性疫苗 (NASVAC) 在治疗结束后三年 (EOT) 对慢性乙型肝炎 (CHB) 患者的安全性和有效性，作为一项随访III 期临床试验。 NASVAC 经鼻给药 10 次，皮下注射给药 5 次。共招募了 59 名慢性乙型肝炎患者。所有患者均未出现不良事件。在 59 名慢性乙型肝炎患者中，有 54 名患者的 HBV DNA 低于其基础水平。尽管所有患者在开始治疗前丙氨酸转氨酶（ALT）均高于正常上限（>42 IU/L），但有 42 名患者的 ALT 水平在 ULN 水平以内。没有患者出现肝硬化。本研究显示了 EOT 3 年后 NASVAC 的安全性和有效性，是第一个报告针对 CHB 的免疫治疗剂的随访数据的研究。 NASVAC 代表了一种独特的 CHB 药物，它安全、持续时间有限、可以通过鼻途径给药、能够降低 HBV DNA 和使 ALT 正常化，并且含有肝纤维化。

关键词：HBsAg/HBcAg 疫苗；纳斯达克；慢性乙型肝炎；跟进;鼻腔疫苗；治疗性疫苗。
赠款支持

    拨款号 20fk0310103h1905/日本医学研究与发展机构 (AMED)
    拨款号 20fk0310103h1904/日本医学研究与发展机构 (AMED)

StephenW

The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial
Sheikh Mohammad Fazle Akbar  1 , Mamun Al Mahtab  2 , Julio Cesar Aguilar  3 , Osamu Yoshida  1 , Sakirul Khan  4 , Eduardo Penton  3 , Guillen Nieto Gerardo  3 , Yoichi Hiasa  1
Affiliations
Affiliations

    1
    Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon 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.
    4
    Department of Microbiology, Faculty of Medicine, Oita University, Oita 879-5593, Japan.

    PMID: 35062707 DOI: 10.3390/vaccines10010045

Abstract

The objective of the present study was to assess the safety and efficacy of a therapeutic vaccine containing both HBsAg and HBcAg (NASVAC) in patients with chronic hepatitis B (CHB) three years after the end of treatment (EOT) as a follow-up of a phase III clinical trial. NASVAC was administered ten times by the nasal route and five times by subcutaneous injection. A total of 59 patients with CHB were enrolled. Adverse events were not seen in any of the patients. Out of the 59 CHB patients, 54 patients exhibited a reduction in HBV DNA, compared with their basal levels. Although all the patients had alanine transaminase (ALT) above the upper limit of normal (>42 IU/L) before the commencement of therapy, the levels of ALT were within the ULN level in 42 patients. No patient developed cirrhosis of the liver. The present study, showing the safety and efficacy of NASVAC 3 years after the EOT, is the first to report follow-up data of an immune therapeutic agent against CHB. NASVAC represents a unique drug against CHB that is safe, of finite duration, can be administered by the nasal route, is capable of reducing HBV DNA and normalizing ALT, and contains hepatic fibrosis.

Keywords: HBsAg/HBcAg vaccine; NASVAC; chronic hepatitis B; follow-up; nasal vaccine; therapeutic vaccine.
Grant support

    Grant number 20fk0310103h1905/Japan Agency for Medical Research and Development (AMED)
    Grant number 20fk0310103h1904/Japan Agency for Medical Research and Development (AMED)

StephenW

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8778341