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首页> 外文期刊>Vaccine >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
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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

机译:带有收费型受体9激动剂佐剂(HBsAg-1018)的研究性乙型肝炎疫苗与许可的乙型肝炎疫苗相比,其免疫原性和安全性

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Background: Hemodialysis patients are at increased risk of hepatitis B virus (HBV) infection and patients with chronic kidney disease (CKD) are commonly hyporesponsive to HBV vaccines. Current recommendations for CKD patients are to utilize 4 double-doses (2 x 20 mcg HBsAg) of a licensed hepatitis B vaccine (HBsAg-Eng). Methods: An observer-blind, randomized, active-controlled, parallel group, multicenter trial was conducted among 521 patients 18-75 years of age with CKD, comparing 3 single doses of an investigational hepatitis B vaccine (20 mcg rHBsAg + 3000 mcg 1018, a toll-like receptor 9 agonist) given at 0, 4, and 24 weeks to 4 double-doses of HBsAg-Eng (2 x 20 mcg rHBsAg + 500 mcg alum) given at 0, 4, 8, and 24 weeks (total of 8 injections). Participants were followed for 1 year. Results: Among 467 participants in the modified intent-to-treat population, at the primary endpoint at week 28, the seroprotection rate (SPR: % with anti-HBs >= 10 mIU/mL) in the HBsAg-1018 group (89.9%) met criteria for noninferiority and superiority to the SPR in the HBsAg-Eng group (81.8%). At week 28, the percentage of participants with anti-HBs >= 100 mIU/mL in theHBsAg-1018 group (73.6%) was significantly higher than in the HBsAg-Eng group (63.2%). In addition, the geometric mean concentration of anti-HBs in the HBsAg-1018 group (587.1 mIU/mL) was significantly higher than in the HBsAg-Eng group (156.5 mIU/mL). At weeks 8 and 12 after the first study injection, SPRs in the HBsAg-1018 group were significantly higher than in the HBsAg-Eng group. At 52 weeks, the immune response toHBsAg-1018 remained higher than to HBsAg-Eng. HBsAg-1018 was generally well tolerated and had a similar safety profile to HBsAg-Eng. Conclusion: In CKD patients, 3 doses of HBsAg-1018 induced significantly higher seroprotection, earlier seroprotection, and more durable seroprotection than 4 double doses of HBsAg-Eng
机译:背景:血液透析患者的乙型肝炎病毒(HBV)感染风险增加,而慢性肾脏病(CKD)患者通常对HBV疫苗反应低下。当前针对CKD患者的建议是使用4种双剂量(2 x 20 mcg HBsAg)的许可乙肝疫苗(HBsAg-Eng)。方法:对521名年龄在18-75岁之间的CKD患者进行了一项观察者盲目的,随机,主动控制,平行分组的多中心试验,比较了三种单剂量的研究性乙型肝炎疫苗(20 mcg rHBsAg + 3000 mcg 1018) ,一种收费型受体9激动剂),分别在第0、4、24周和第0、4、8和24周给予4双重剂量的HBsAg-Eng(2 x 20 mcg rHBsAg + 500 mcg明矾)(总共8次注射)。参与者被追踪了一年。结果:在经过改良的意向性治疗人群中的467名参与者中,在第28周的主要终点,HBsAg-1018组的血清保护率(SPR:%,抗HBs> = 10 mIU / mL)(89.9%) )符合HBsAg-Eng组(81.8%)的非劣性和优于SPR的标准。在第28周时,HBsAg-1018组中抗HBs> = 100 mIU / mL的参与者百分比(73.6%)显着高于HBsAg-Eng组(63.2%)。此外,HBsAg-1018组中抗HBs的几何平均浓度(587.1 mIU / mL)明显高于HBsAg-Eng组中的156.5 mIU / mL。首次研究注射后第8周和第12周,HBsAg-1018组的SPR显着高于HBsAg-Eng组。在第52周时,对HBsAg-1018的免疫反应仍然高于对HBsAg-Eng的免疫反应。 HBsAg-1018通常耐受性良好,并且安全性与HBsAg-Eng相似。结论:在CKD患者中,与4剂双倍剂量的HBsAg-Eng相比,3剂HBsAg-1018诱导的血清保护显着更高,更早的血清保护和更持久的血清保护。

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