慢性肾脏病成人中乙型肝炎疫苗 HepB-CpG（HEPLISAV-B）与 HepB-Eng（Engerix-B）的长期免疫原性和安全性比较。
Long-term immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) compared with HepB-Eng (Engerix-B) in adults with chronic kidney disease.
机构信息
Department of Internal Medicine II, Martin-Luther-University Halle-Wittenberg, Ernst-Grube-Strasse 40, Halle 06120, Germany.
Amherst Family Practice, 1867 Amherst Street, Winchester, VA 22601, USA.
出版信息
Vaccine. 2023 May 11;41(20):3224-3232. doi: 10.1016/j.vaccine.2023.04.028. Epub 2023 Apr 19.
BACKGROUND
Hepatitis B virus (HBV) infection remains a significant global burden, especially for patients with chronic kidney disease (CKD) receiving hemodialysis. Three doses of HepB-CpG (HEPLISAV-B® vaccine) induced a superior immune response compared with 4 double doses of HepB-Eng (Engerix-B®) in a phase 3 trial (HBV-17) in adults with CKD. Here we report the long-term immunogenicity and safety of HepB-CpG and HepB-Eng in eligible participants of HBV-17 who enrolled in this optional 34-month follow-up trial (HBV-19).
METHODS
HBV-19 is a multicenter, open-label, phase 3b trial of adults with CKD who previously received a complete series of HepB-CpG or HepB-Eng in the HBV-17 trial. Participants were assigned to seroprotection categories at enrollment on the basis of their antibody response to hepatitis B surface antigen (anti-HBs) in HBV-17. The objective was to evaluate the durability of seroprotection (defined as an anti-HBs concentration ≥ 10mIU/mL) induced by HepB-CpG and HepB-Eng. Participants whose anti-HBs concentration was below 10mIU/mL received additional HepB-CpG or HepB-Eng doses.
RESULTS
147 participants were enrolled; 66.7 % were men, median age was 65.0 years, and 83.7 % were white. The durability of seroprotection in participants with CKD was similar in those who received HepB-CpG and those who received HepB-Eng. Antibody concentrations ≥ 100mIU/mL persisted for longer in HepB-CpG than HepB-Eng recipients, among those with anti-HBs ≥ 100mIU/mL post vaccination. The geometric mean anti-HBs concentration in the HepB-CpG group was significantly higher than in the HepB-Eng group over time (P ≤ 0.0001). The safety profiles were similar between the vaccine groups.
CONCLUSIONS
Due to the higher antibody levels induced by HepB-CpG in participants with CKD, seroprotection against HBV may be expected to persist longer than that induced by HepB-Eng.
CLINICALTRIALS
gov: NCT01282762.
背景
乙型肝炎病毒（HBV）感染仍然是一个重大的全球负担，尤其是对接受血液透析的慢性肾脏病（CKD）患者。在一项 3 期试验（HBV-17）中，与 4 剂乙型肝炎免疫球蛋白（Engerix-B®）相比，3 剂 HepB-CpG（HEPLISAV-B®疫苗）在 CKD 成人中诱导了更好的免疫应答。在这里，我们报告了在 HBV-17 中接受完整系列 HepB-CpG 或 HepB-Eng 的合格参与者参加的这项可选的 34 个月随访试验（HBV-19）中 HepB-CpG 和 HepB-Eng 的长期免疫原性和安全性。
方法
HBV-19 是一项多中心、开放性、3b 期试验，纳入了先前在 HBV-17 试验中接受完整系列 HepB-CpG 或 HepB-Eng 的 CKD 成人患者。根据 HBV-17 中抗乙型肝炎表面抗原（抗-HBs）的抗体反应，在入组时将参与者分配到血清保护类别。目的是评估 HepB-CpG 和 HepB-Eng 诱导的血清保护（定义为抗-HBs 浓度≥10mIU/mL）的持久性。抗-HBs 浓度低于 10mIU/mL 的参与者接受了额外的 HepB-CpG 或 HepB-Eng 剂量。
结果
共纳入 147 名参与者；66.7%为男性，中位年龄为 65.0 岁，83.7%为白人。在接受 HepB-CpG 和 HepB-Eng 的 CKD 患者中，血清保护的持久性相似。在接种疫苗后抗-HBs≥100mIU/mL 的患者中，HepB-CpG 组的抗体浓度≥100mIU/mL 的持续时间长于 HepB-Eng 组。HepB-CpG 组的几何平均抗-HBs 浓度随时间的推移明显高于 HepB-Eng 组（P≤0.0001）。疫苗组的安全性特征相似。
结论
由于 HepB-CpG 在 CKD 患者中诱导的抗体水平较高，因此对 HBV 的血清保护作用可能比 HepB-Eng 诱导的保护作用持续时间更长。
临床试验
gov：NCT01282762。
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