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 health

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• 作者：Scott A. Halperin ; Simon Dobson ; Shelly McNeil ; Joanne M. Langley ; Bruce Smith ; Robyn McCall-Sani ; Dan Levitt ; Gary Van Nest ; Daniel Gennevois and Joseph J. Eiden
• 刊名：Vaccine
• 出版年：2006
• 出版时间：9 January 2006
• 年：2006
• 卷：24
• 期：1
• 页码：20-26
• 全文大小：129 K

文摘

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^® (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^® 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^® 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^® after both doses (74–77 % compared to 34–58 % ; p ≤ 0.029).

Conclusions

Protective levels are achieved more quickly and after fewer doses of HBV-ISS than Engerix-B^®. HBV-ISS is well tolerated but associated with more mild injection-site tenderness than Engerix-B^®.