Comparison of the safety and immunogenicity of hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide and a licensed hepatitis B vaccine in healthy young adults
Comparison of the safety and immunogenicity of hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide and a licensed hepatitis B vaccine in healthy young adults
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DOI：
10.1016/j.vaccine.2005.08.095
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发表时间：
2006-01-09
期刊：
影响因子：
5.5
通讯作者：
Eiden, JJ
中科院分区：
文献类型：
--
作者：
Halperin, SA;Dobson, S;Eiden, JJ
背景：许多人对三剂系列乙型肝炎疫苗（HBV）没有反应，大多数人直到第2剂或第3剂之后才达到保护性抗体反应。方法：18-28岁的健康成人，血清阴性，随机等数分配，接受两剂实验疫苗（不含明矾的HBV-ISS）（0,8周）和安慰剂（24周）或Engerix-B-(R)（0,8, 24周）。在每次注射后第1周和第4周收集不良事件。第1剂量后4周检测抗体；剂量2后1周和4周，剂量3后1周和4周以及1年后。结果：纳入99名参与者（65%为女性，平均年龄22.6岁）。79%的HBV-ISS和12%的Engerix-B-(R)受体在剂量1后4周出现保护性抗体应答（几何平均浓度[GMC]分别为23.0和1.87 mIU/mL）。剂量2后1周，100%的HBV-ISS和18%的Engerix-B-(R)受体达到保护水平（GMC 1603 vs 2.40 mIU/mL）。两组不良事件发生率低且相似；头痛和疲劳是两组中最常见的系统性不良事件，发生率均达1/3。两种剂量的HBV-ISS后，轻度注射部位压痛比Engerix-B-(R)更常见(74-77%比34-58%
Background:: Many individuals do not respond to a three-dose series of hepatitis B vaccine (HBV) and most do not achieve a protective antibody response until after dose 2 or 3.Methods:: Healthy, seronegative 18-28 year old adults were randomly assigned in equal numbers to receive two doses of the experimental vaccine (HBV-ISS without alum) (0, 8 weeks) and placebo (24 weeks) or Engerix-B-(R) (0, 8, 24 weeks). Adverse events were collected during the first week and at 4 weeks after each injection. Antibodies were measured 4 weeks after dose 1; before, 1 and 4 weeks after dose 2, and before, 1 and 4 weeks after dose 3 and at 1 year.Results:: Ninety-nine participants were enrolled (65% female; mean age 22.6 years). 79% of HBV-ISS and 12% of Engerix-B-(R) recipients had a protective antibody response 4 weeks post dose 1 (geometric mean concentration [GMC] 23.0 and 1.87 mIU/mL, respectively). By 1 week post dose 2, 100% of HBV-ISS and 18% Engerix-B-(R) recipients had protective levels (GMC 1603 versus 2.40 mIU/mL). Rates of adverse events were low and similar in both groups; headache and fatigue were the most common systemic adverse events in up to 1/3 of both groups. Mild injection-site tenderness was more common after HBV-ISS than Engerix-B-(R) after both doses (74-77% compared to 34-58%; p