Advanced Medical Research Institute of Canada; Sudbury, ON Canada.
Hum Vaccin Immunother. 2013 Aug;9(8):1661-72. doi: 10.4161/hv.24715. Epub 2013 May 31.
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.
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。
