1018ISS 佐剂在乙型肝炎疫苗中的潜力：HEPLISAV™ 综述。
The potential of 1018 ISS adjuvant in hepatitis B vaccines: HEPLISAV™ review.
机构信息
Advanced Medical Research Institute of Canada; Sudbury, ON Canada.
出版信息
Hum Vaccin Immunother. 2013 Aug;9(8):1661-72. doi: 10.4161/hv.24715. Epub 2013 May 31.
Abstract
Hepatitis B (HBV) virus infects the liver, and upon chronic infection, can cause liver cirrhosis and hepatocellular carcinoma. Despite universal vaccination programs against the virus, HBV still affects over 2 billion people worldwide, with over 240 million developing a chronic infection. While current alum-adjuvanted vaccines have shown efficacy in promoting seroprotection in healthy adults, 5-10% of immune-competent populations fail to achieve long-lasting seroprotection from these formulations. Furthermore, a large proportion of immunocompromised patients fail to achieve seroprotective antibody titers after receiving these vaccines. A novel vaccine candidate, HEPLISAV™, uses immunostimulatory sequences (ISS), in its formulation that helps induce a robust humoral and cell mediated immunity against HBV. In Phase III clinical trials, HEPLISAV™ has been shown to elicit seroprotective antibody titers with fewer immunizations. Similar safety profiles are demonstrated when compared with current HBV vaccines. For these reasons, HEPLISAV™ is an attractive vaccine to combat this global disease.
摘要
乙型肝炎病毒（HBV）感染肝脏，在慢性感染时，可导致肝硬化和肝细胞癌。尽管有针对该病毒的普遍疫苗接种计划，但 HBV 仍影响着全球超过 20 亿人，其中超过 2.4 亿人发展为慢性感染。虽然目前含铝佐剂的疫苗已显示出在健康成年人中促进血清保护的功效，但 5-10%的免疫功能正常人群无法从这些制剂中获得持久的血清保护。此外，很大一部分免疫功能低下的患者在接种这些疫苗后无法达到血清保护性抗体滴度。一种新型疫苗候选物 HEPLISAV™在其配方中使用免疫刺激序列（ISS），有助于诱导针对 HBV 的强大体液和细胞介导免疫。在 III 期临床试验中，HEPLISAV™ 显示出较少的免疫接种次数即可产生血清保护抗体滴度。与目前的 HBV 疫苗相比，其安全性谱相似。基于这些原因，HEPLISAV™ 是一种有吸引力的疫苗，可以对抗这种全球性疾病。
相似文献
1
The potential of 1018 ISS adjuvant in hepatitis B vaccines: HEPLISAV™ review.1018ISS 佐剂在乙型肝炎疫苗中的潜力：HEPLISAV™ 综述。
Hum Vaccin Immunother. 2013 Aug;9(8):1661-72. doi: 10.4161/hv.24715. Epub 2013 May 31.
2
Hepatitis B surface antigen-1018 ISS adjuvant-containing vaccine: a review of HEPLISAV™ safety and efficacy.含乙肝表面抗原 1018 位免疫增强序贯佐剂的疫苗：HEPLISAV™ 的安全性和有效性评价。
Expert Rev Vaccines. 2011 Apr;10(4):417-27. doi: 10.1586/erv.10.162.
3
Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18-55 years of age.在 18-55 岁健康成年人中，比较两种剂量的研究用乙型肝炎病毒表面抗原与免疫刺激性硫代磷酸寡脱氧核苷酸联合使用，以及三种剂量的已上市乙型肝炎疫苗的安全性和免疫原性。
Vaccine. 2012 Mar 28;30(15):2556-63. doi: 10.1016/j.vaccine.2012.01.087. Epub 2012 Feb 9.
4
Immunogenicity and safety of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease.在慢性肾脏病患者中，与已上市乙型肝炎疫苗相比，含 Toll 样受体 9 激动剂佐剂（HBsAg-1018）的乙型肝炎疫苗的免疫原性和安全性。
Vaccine. 2013 Nov 4;31(46):5306-13. doi: 10.1016/j.vaccine.2013.05.067. Epub 2013 May 30.
5
Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age.在 40-70 岁健康成年人中，与已上市乙型肝炎疫苗相比，含 Toll 样受体 9 激动剂佐剂（HBsAg-1018）的乙型肝炎疫苗的免疫原性和安全性。
Vaccine. 2013 Nov 4;31(46):5300-5. doi: 10.1016/j.vaccine.2013.05.068. Epub 2013 May 30.
6
Safety and immunogenicity of different two-dose regimens of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in healthy young adults.在健康的年轻成年人中，不同两剂方案的乙型肝炎疫苗（乙型肝炎表面抗原与免疫刺激型硫代磷酸寡脱氧核苷酸联合使用）的安全性和免疫原性。
Vaccine. 2012 Aug 3;30(36):5445-8. doi: 10.1016/j.vaccine.2012.05.074. Epub 2012 Jun 13.
7
Hepatitis B virus vaccine in chronic kidney disease: improved immunogenicity by adjuvants? A meta-analysis of randomized trials.乙型肝炎病毒疫苗在慢性肾脏病中的应用：佐剂是否可提高其免疫原性？一项随机试验的荟萃分析。
Vaccine. 2012 Mar 16;30(13):2295-300. doi: 10.1016/j.vaccine.2012.01.064. Epub 2012 Jan 26.
8
Comparison of the safety and immunogenicity of hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide and a licensed hepatitis B vaccine in healthy young adults.在健康年轻成年人中比较乙肝病毒表面抗原与免疫刺激性硫代磷酸酯寡核苷酸及已获许可的乙肝疫苗共同给药的安全性和免疫原性。
Vaccine. 2006 Jan 9;24(1):20-6. doi: 10.1016/j.vaccine.2005.08.095. Epub 2005 Sep 12.
9
Hepatitis B virus vaccine in lymphoproliferative disorders: a prospective randomized study evaluating the efficacy of granulocyte-macrophage colony stimulating factor as a vaccine adjuvant.淋巴细胞增殖性疾病中的乙肝病毒疫苗：一项评估粒细胞巨噬细胞集落刺激因子作为疫苗佐剂疗效的前瞻性随机研究。
Eur J Haematol. 2007 Oct;79(4):292-6. doi: 10.1111/j.1600-0609.2007.00912.x. Epub 2007 Jul 26.
10
Review of hepatitis B surface antigen-1018 ISS adjuvant-containing vaccine safety and efficacy.含乙肝表面抗原-1018 ISS佐剂疫苗的安全性和有效性综述。
Expert Opin Biol Ther. 2007 Nov;7(11):1731-7. doi: 10.1517/14712598.7.11.1731.
引用本文的文献
1
Toll-like receptor response to Zika virus infection: progress toward infection control.Toll样受体对寨卡病毒感染的反应：感染控制方面的进展
Npj Viruses. 2025 Mar 13;3(1):20. doi: 10.1038/s44298-025-00102-3.
2
Beyond Needles: Immunomodulatory Hydrogel-Guided Vaccine Delivery Systems.超越针头：免疫调节水凝胶引导的疫苗递送系统
Gels. 2024 Dec 26;11(1):7. doi: 10.3390/gels11010007.
3
Recent Insights into the Molecular Mechanisms of the Toll-like Receptor Response to Influenza Virus Infection.近期对 Toll 样受体（TLR）响应流感病毒感染的分子机制的深入了解。
Int J Mol Sci. 2024 May 29;25(11):5909. doi: 10.3390/ijms25115909.
4
TLR agonists as vaccine adjuvants in the prevention of viral infections: an overview.Toll样受体激动剂作为预防病毒感染的疫苗佐剂：概述
Front Microbiol. 2023 Dec 21;14:1249718. doi: 10.3389/fmicb.2023.1249718. eCollection 2023.
5
Immune response induced by recombinant pres2/S-protein and a pres2-S-protein fused with a core 18-27 antigen fragment of hepatitis B virus compared to conventional HBV vaccine.与传统乙肝疫苗相比，重组 preS2/S 蛋白和与乙肝病毒核心 18-27 抗原片段融合的 preS2-S 蛋白诱导的免疫应答。
Virus Genes. 2023 Aug;59(4):499-514. doi: 10.1007/s11262-023-01995-z. Epub 2023 May 4.
6
Chemistry, structure and function of approved oligonucleotide therapeutics.已获批的寡核苷酸治疗药物的化学、结构和功能。
Nucleic Acids Res. 2023 Apr 11;51(6):2529-2573. doi: 10.1093/nar/gkad067.
7
Comparison of Immune Response in Mice Immunized with Recombinant PreS2/S-C18-27 Protein Derived from Hepatitis B Virus with Commercial Vaccine.用重组乙肝病毒前S2/S-C18-27蛋白免疫的小鼠与商用疫苗免疫的小鼠免疫反应比较。
Iran J Pathol. 2022 Fall;17(4):448-460. doi: 10.30699/IJP.2022.553785.2896. Epub 2022 Sep 2.
8
Vaccine adjuvants to engage the cross-presentation pathway.疫苗佐剂以激活交叉呈递途径。
Front Immunol. 2022 Aug 1;13:940047. doi: 10.3389/fimmu.2022.940047. eCollection 2022.
9
Magnitude and breadth of antibody cross-reactivity induced by recombinant influenza hemagglutinin trimer vaccine is enhanced by combination adjuvants.重组流感血凝素三聚体疫苗诱导的抗体交叉反应的幅度和广度可通过联合佐剂增强。
Sci Rep. 2022 Jun 2;12(1):9198. doi: 10.1038/s41598-022-12727-y.
10
Ionizable Lipid Nanoparticles Enhanced the Synergistic Adjuvant Effect of CpG ODNs and QS21 in a Varicella Zoster Virus Glycoprotein E Subunit Vaccine.可电离脂质纳米颗粒增强了水痘带状疱疹病毒糖蛋白E亚单位疫苗中CpG ODNs和QS21的协同佐剂作用。
Pharmaceutics. 2022 Apr 30;14(5):973. doi: 10.3390/pharmaceutics14050973.
本文引用的文献
1
Safety and immunogenicity of different two-dose regimens of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in healthy young adults.在健康的年轻成年人中，不同两剂方案的乙型肝炎疫苗（乙型肝炎表面抗原与免疫刺激型硫代磷酸寡脱氧核苷酸联合使用）的安全性和免疫原性。
Vaccine. 2012 Aug 3;30(36):5445-8. doi: 10.1016/j.vaccine.2012.05.074. Epub 2012 Jun 13.
2
Comparative risk of liver-related mortality from chronic hepatitis B versus chronic hepatitis C virus infection.慢性乙型肝炎与慢性丙型肝炎病毒感染相关的肝相关死亡率的比较风险。
Clin Infect Dis. 2012 Aug;55(4):507-13. doi: 10.1093/cid/cis432. Epub 2012 Apr 20.
3
Demonstration of safety and enhanced seroprotection against hepatitis B with investigational HBsAg-1018 ISS vaccine compared to a licensed hepatitis B vaccine.与已上市乙型肝炎疫苗相比，新型 HBsAg-1018 ISS 疫苗具有良好的安全性，并可增强乙型肝炎的血清保护作用。
Vaccine. 2012 Mar 30;30(16):2689-96. doi: 10.1016/j.vaccine.2012.02.001. Epub 2012 Feb 14.
4
Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18-55 years of age.在 18-55 岁健康成年人中，比较两种剂量的研究用乙型肝炎病毒表面抗原与免疫刺激性硫代磷酸寡脱氧核苷酸联合使用，以及三种剂量的已上市乙型肝炎疫苗的安全性和免疫原性。
Vaccine. 2012 Mar 28;30(15):2556-63. doi: 10.1016/j.vaccine.2012.01.087. Epub 2012 Feb 9.
5
Vaccine adjuvants: putting innate immunity to work.疫苗佐剂：充分发挥固有免疫的作用。
Immunity. 2010 Oct 29;33(4):492-503. doi: 10.1016/j.immuni.2010.10.002.
6
Hepatitis B vaccines.乙肝疫苗
Wkly Epidemiol Rec. 2009 Oct 1;84(40):405-19.
7
Vaccination in the elderly: an immunological perspective.老年人的疫苗接种：免疫学视角
Trends Immunol. 2009 Jul;30(7):351-9. doi: 10.1016/j.it.2009.05.002. Epub 2009 Jun 18.
8
Persistence of protection against hepatitis B virus infection among adolescents vaccinated with recombinant hepatitis B vaccine beginning at birth: a 15-year follow-up study.对从出生开始接种重组乙型肝炎疫苗的青少年中乙型肝炎病毒感染防护的持续性：一项15年随访研究。
Pediatr Infect Dis J. 2008 Oct;27(10):881-5. doi: 10.1097/INF.0b013e31817702ba.
9
Alum adjuvanticity: unraveling a century old mystery.明矾佐剂活性：解开一个百年之谜。
Eur J Immunol. 2008 Aug;38(8):2068-71. doi: 10.1002/eji.200838648.
10
Molecular and cellular signatures of human vaccine adjuvants.人类疫苗佐剂的分子和细胞特征
Proc Natl Acad Sci U S A. 2008 Jul 29;105(30):10501-6. doi: 10.1073/pnas.0804699105. Epub 2008 Jul 23.
Zotero 插件