Division of Gastroenterology and Hepatology, Department of Medicine, National University Hospital, Singapore, Singapore.
Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Expert Rev Vaccines. 2021 May;20(5):487-495. doi: 10.1080/14760584.2021.1908133. Epub 2021 Apr 9.
: HEPLISAV-B is a hepatitis B vaccine composed of rHBsAg mixed with a synthetic oligonucleotide containing CpG motifs that stimulate innate immunity through TLR9. This vaccine was recently approved by FDA in view of its superior efficacy.: Published literature on HEPLISAV-B was critically reviewed. Four randomized controlled trials among 7,056 subjects receiving 2 doses of HEPLISAV-B and 3,214 subjects receiving 3 doses of Engerix-B showed superior seroprotection rate (SPR) (anti-HBs ≥10 mIU/mL) of 90-100%, compared with 71-90% in those receiving Engerix-B. Furthermore, the seroprotection rate was also significantly higher in HEPLISAV-B compared with Engerix-B recipients in persons with traditionally poor vaccine responses such as older adults, diabetics, and those with chronic kidney disease. The safety profiles among 9,871 subjects were similar between HEPLISAV-B and Engerix-B .: HEPLISAV-B, a CpG adjuvant mixed with HBsAg, is more efficacious and produced earlier seroprotection compared to existing vaccines, with a favorable safety profile. The shorter, two-dose regimen, earlier seroprotection, higher adherence, and a higher seroprotection rate, especially in populations with traditionally poor vaccine response, makes this an important therapeutic option in hepatitis B vaccination.
: HEPLISAV-B 是一种乙型肝炎疫苗，由 rHBsAg 与含有 CpG 基序的合成寡核苷酸混合而成，通过 TLR9 刺激固有免疫。鉴于其优异的疗效，该疫苗最近获得了 FDA 的批准。: 对 HEPLISAV-B 的已发表文献进行了批判性评价。在接受 2 剂 HEPLISAV-B 和 3214 剂 Engerix-B 的 7056 名受试者和接受 3 剂 Engerix-B 的 3214 名受试者的 4 项随机对照试验中，与接受 Engerix-B 的受试者的 71-90%相比，其血清保护率（SPR）（抗-HBs≥10 mIU/mL）更高，为 90-100%。此外，在传统疫苗反应较差的人群中，如老年人、糖尿病患者和慢性肾脏病患者，与接受 Engerix-B 的受试者相比，HEPLISAV-B 组的血清保护率也显著更高。在 9871 名受试者中，HEPLISAV-B 和 Engerix-B 的安全性谱相似。: HEPLISAV-B 是一种 CpG 佐剂与 HBsAg 混合的疫苗，与现有疫苗相比，其疗效更高，产生血清保护作用更早，安全性良好。较短的两剂方案、更早的血清保护、更高的依从性以及更高的血清保护率，尤其是在传统疫苗反应较差的人群中，使该疫苗成为乙型肝炎疫苗接种的重要治疗选择。
