Comparison of safety and immunogenicity of two doses of investigational hepatiti

StephenW

Vaccine. 2012 Feb 8. [Epub ahead of print]
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.Halperin SA, Ward B, Cooper C, Predy G, Diaz-Mitoma F, Dionne M, Embree J, McGeer A, Zickler P, Moltz KH, Martz R, Meyer I, McNeil S, Langley JM, Martins E, Heyward WL, Martin JT.
SourceCanadian Center for Vaccinology, Dalhousie University and the IWK Health Centre, Halifax, Canada.

AbstractBACKGROUND: The currently licensed, aluminum hydroxide adjuvanted hepatitis B vaccines require three doses over a 6-month period to achieve high rates of protection in adults. We compared tolerability and immunogenicity of two doses of an investigational hepatitis B vaccine using hepatitis B surface antigen adjuvanted with an immunostimulatory phosphorothioate oligodeoxyribonucleotide (HBV-ISS) to three doses of a licensed alum-adjuvanted vaccine (HBV-Eng).
METHODS: In this randomized, observer-blind study, healthy adults received two doses of HBV-ISS at 0 and 4 weeks or three doses of HBV-Eng at 0, 4, and 24 weeks. The primary immunogenicity endpoint was the seroprotection rate (antibody≥10mIU/mL) 8 weeks after the second dose of HBV-ISS compared to 4 weeks after the third dose of HBV-Eng.
RESULTS: A total of 2415 participants were randomized in a ratio of 3:1 to HBV-ISS (n=1809) and HBV-Eng (n=606). The percentage of subjects exhibiting a seroprotective immune response at the primary time point was significantly higher (95.1%) for HBV-ISS than for HBV-Eng (81.1%). Superiority of the seroprotective rates for HBV-ISS was demonstrated at all time points measured. Geometric mean concentrations were also significantly higher in the HBV-ISS group at all time points measured except at week 28 (24 weeks post-second dose of HBV-ISS and 4 weeks post-third dose HBV-ISS) at which time the antibody concentrations were similar. Both vaccines were well-tolerated although injection site reactions were reported at a higher rate in HBV-ISS recipients.
CONCLUSIONS: A short, two-dose regimen of HBV-ISS induced a superior antibody response than a three-dose regimen of a licensed hepatitis B vaccine and was well tolerated.
Copyright © 2012. Published by Elsevier Ltd.





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StephenW

疫苗。 2012年二月8。 [出处提前打印]
研究B型肝炎病毒表面抗原的免疫刺激硫代寡脱氧核苷酸和三个持牌肝炎的18-55岁的健康成人接种乙肝疫苗的剂量与合作管理两个剂量的安全性和免疫原性的比较。
霍尔珀林的SA，乙区，库珀C，PredyĞ，迪亚兹，Mitoma F，迪翁中号，恩布里J，麦克吉尔一个，Zickler带够，Moltz锦，ŕM​​artz，迈耶我，麦克尼尔小号，兰利JM，马丁斯é，海沃德轮候册，马丁·托德。
源

加拿大疫苗，达尔豪西大学和IWK健康中心，加拿大哈利法克斯中心。
抽象
背景：

目前行货，氢氧化铝佐剂乙肝疫苗需要三个剂量超过6个月的时间内实现高保护率在成年人。我们比较两种剂量使用乙肝表面抗原与免疫刺激硫代寡脱氧核苷酸（乙肝ISS）三个剂量持牌明矾佐剂疫苗（HBV-ENG）佐剂的研究乙型肝炎疫苗的耐受性和免疫原性。
方法：

观察员这项随机，双盲研究中，健康的成年人接受两个剂量乙肝ISS在0和4个星期或3个剂量HBV-ENG 0，4周和24周。主要免疫原性终点是血清保护率（抗体≥10mIU/mL），8周后，第二至4周后HBV-ENG第三剂量相比剂量乙肝ISS。
结果：

共有2415参与者被随机乙肝ISS在3:1的比例（N = 1809）和HBV-ENG（N = 606）。参展的主要时间点seroprotective免疫反应的受试者的百分比显着高于乙肝ISS（95.1％）比HBV-ENG（81.1％）。乙肝ISS seroprotective率的优势表现在所有的时间测量点。几何平均浓度也显着较高的HBV-ISS组除在第28周（24周后第二次乙肝ISS和4周后，第三剂量乙肝ISS）在这一次的抗体浓度来衡量所有的时间点是相似的。这两种疫苗的耐受性良好，但注射部位反应报告率较高，在乙肝病毒ISS受助人。
结论：

短，两剂量乙肝国际空间站的方案引发了三个剂量比持牌乙肝疫苗的方案优越的抗体反应和耐受性良好。