The Safety and Efficacy of a Therapeutic Vaccine for Chronic Hepatitis B: A Follow-Up Study of Phase III Clinical Trial

被引:14
|
作者
Akbar, Sheikh Mohammad Fazle [1 ]
Al Mahtab, Mamun [2 ]
Aguilar, Julio Cesar [3 ]
Yoshida, Osamu [1 ]
Khan, Sakirul [4 ]
Penton, Eduardo [3 ]
Gerardo, Guillen Nieto [3 ]
Hiasa, Yoichi [1 ]
机构
[1] Ehime Univ, Grad Sch Med, Dept Gastroenterol & Metabol, Toon 7910295, Japan
[2] Bangabandhu Sheikh Mujib Med Univ BSMMU, Dept Hepatol, Dhaka 1000, Bangladesh
[3] Ctr Genet Engn & Biotechnol, Havana 10600, Cuba
[4] Oita Univ, Fac Med, Dept Microbiol, Oita 8795593, Japan
关键词
chronic hepatitis B; therapeutic vaccine; HBsAg; HBcAg vaccine; NASVAC; nasal vaccine; follow-up; CORE ANTIGEN; SURFACE; CANDIDATE; CELLS; HBCAG;
D O I
10.3390/vaccines10010045
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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.
引用
收藏
页数:9
相关论文
共 50 条
  • [41] The efficacy and safety of thymosin alpha-1 in Japanese patients with chronic hepatitis B; results from a randomized clinical trial
    Iino, S
    Toyota, J
    Kumada, H
    Kiyosawa, K
    Kakumu, S
    Sata, M
    Suzuki, H
    Martins, EB
    JOURNAL OF VIRAL HEPATITIS, 2005, 12 (03) : 300 - 306
  • [42] Efficacy and safety of GLS4 with entecavir vs entecavir alone in chronic hepatitis B patients: A multicenter clinical trial
    Zhang, Mingyuan
    Gao, Yanhang
    Kong, Fei
    Gao, Haibing
    Yi, Yongxiang
    Wu, Chao
    Xin, Yongning
    Zheng, Sujun
    Lu, Jiajie
    Han, Tao
    Zhao, Yingren
    Hu, Peng
    Mao, Xiaorong
    Xie, Qing
    Zhang, Jie
    Hou, Jinlin
    Gao, Zhiliang
    Lian, Jianqi
    Chen, Liang
    Shang, Jia
    Xie, Wen
    Mu, Mao
    Jin, Zhenjing
    Wang, Maorong
    Lin, Shide
    Rao, Huiying
    Yang, Dongliang
    Gong, Huanyu
    Luo, Lin
    Chen, Yunfu
    Zhuang, Yulei
    Zhang, Yingjun
    Gish, Robert G.
    Tan, Youwen
    Zhang, Jiming
    Niu, Junqi
    JOURNAL OF INFECTION, 2025, 90 (03)
  • [43] Ten-year follow-up of hepatitis B relapse after cessation of lamivudine or telbivudine treatment in chronic hepatitis B patients
    Pan, H. -Y.
    Pan, H. -Y.
    Chen, L.
    Yang, D. -H.
    Huang, H. -J.
    Tong, Y. -X.
    Chen, C. -R.
    Yan, J.
    CLINICAL MICROBIOLOGY AND INFECTION, 2015, 21 (12) : 1123.e1 - 1123.e9
  • [44] Clinical and immunological efficacy of intradermal vaccine plus lamivudine with or without interleukin-2 in patients with chronic hepatitis B
    Dahmen, A
    Herzog-Hauff, S
    Böcher, WO
    Galle, PR
    Löhr, HF
    JOURNAL OF MEDICAL VIROLOGY, 2002, 66 (04) : 452 - 460
  • [45] Extended Safety, Immunogenicity and Efficacy of a Blood-Stage Malaria Vaccine in Malian Children: 24-Month Follow-Up of a Randomized, Double-Blinded Phase 2 Trial
    Laurens, Matthew B.
    Thera, Mahamadou A.
    Coulibaly, Drissa
    Ouattara, Amed
    Kone, Abdoulaye K.
    Guindo, Ando B.
    Traore, Karim
    Traore, Idrissa
    Kouriba, Bourema
    Diallo, Dapa A.
    Diarra, Issa
    Daou, Modibo
    Dolo, Amagana
    Tolo, Youssouf
    Sissoko, Mahamadou S.
    Niangaly, Amadou
    Sissoko, Mady
    Takala-Harrison, Shannon
    Lyke, Kirsten E.
    Wu, Yukun
    Blackwelder, William C.
    Godeaux, Olivier
    Vekemans, Johan
    Dubois, Marie-Claude
    Ballou, W. Ripley
    Cohen, Joe
    Dube, Tina
    Soisson, Lorraine
    Diggs, Carter L.
    House, Brent
    Bennett, Jason W.
    Lanar, David E.
    Dutta, Sheetij
    Heppner, D. Gray
    Plowe, Christopher V.
    Doumbo, Ogobara K.
    PLOS ONE, 2013, 8 (11):
  • [46] Autologus dendritic cell vaccine for chronic hepatitis B carriers: A pilot, open label, clinical trial in human volunteers
    Luo, Jin
    Li, Jun
    Chen, Rui L.
    Nie, Lei
    Huang, Jie
    Liu, Zheng W.
    Luo, Lin
    Yan, Xiao J.
    VACCINE, 2010, 28 (13) : 2497 - 2504
  • [47] Persistence of protection against hepatitis B virus infection among adolescents vaccinated with recombinant hepatitis B vaccine beginning at birth - A 75-year follow-up study
    Bialek, Stephanie R.
    Bower, William A.
    Novak, Ryan
    Helgenberger, Louisa
    Auerbach, Steven B.
    Williams, Ian T.
    Bell, Beth P.
    PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2008, 27 (10) : 881 - 885
  • [48] Factors associated with adherence to nucleos(t)ide analogs in chronic hepatitis B patients: results from a 1-year follow-up study
    Peng, Jie
    Yin, Junhua
    Cai, Shaohang
    Zhong, Chunxiu
    PATIENT PREFERENCE AND ADHERENCE, 2015, 9 : 41 - 45
  • [49] Discontinuation of lamivudine treatment in HBeAg-negative chronic hepatitis B: a pilot study with long-term follow-up
    Karakaya, Fatih
    Ozer, Sevil
    Kalkan, Cagdas
    Tuzun, E. Ali
    Caliskan, Aysun
    Keskin, Onur
    Kabacam, Gokhan
    Karatayli, Senem
    Karatayli, Ersin
    Bozdayi, A. Mithat
    Idilman, Ramazan
    Yurdaydin, Cihan
    ANTIVIRAL THERAPY, 2017, 22 (07) : 559 - 570
  • [50] Reduced liver cancer mortality with regular clinic follow-up among patients with chronic hepatitis B: A nationwide cohort study
    Shim, Jae-Jun
    Kim, Gi-Ae
    Oh, Chi Hyuk
    Kim, Jung Wook
    Myung, Jisun
    Kim, Byung-Ho
    Oh, In-Hwan
    CANCER MEDICINE, 2020, 9 (20): : 7781 - 7791