混合人群对本土研发的重组乙型肝炎疫苗的免疫反应：加速接种程序的研究

Immune response to an indigenously developed r-hepatitis B vaccine in mixed population: study of an accelerated vaccination schedule.

作者信息

Chowdhury A, Santra A, Habibullah C-M, Khan A-A, Karunakaramaiah J, Kishore T-S-A, Raju A-V-R, Lahiri S

机构信息

Department of Clinical and Regulatory Affairs, Biological E.Limited, 18/1 and 3 Azamabad, Hyderabad, Zip-500020, India.

出版信息

World J Gastroenterol. 2005 Feb 21;11(7):1037-9. doi: 10.3748/wjg.v11.i7.1037.

DOI:10.3748/wjg.v11.i7.1037

PMID:15742410

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4250767/

Abstract

AIM

To establish the safety and efficacy of an indigenously developed r-hepatitis B vaccine using an accelerated schedule and to highlight the social awareness and commitment in preventing the spreading of hepatitis B virus infection.

METHODS

The study was a multicentric, double blind, randomized (3:1) study using three doses of vaccine immunization schedule (20 mug for those above 10 years old and 10 mug for those below 10 years old) on d 0, 30 and 60. One hundred and sixty-six subjects were enrolled (87 males and 76 females aged 5-35 years). The main outcome measure was assessment of immunogenicity and safety.

RESULTS

A 100% seroconversion response was observed on the 30(th) d after the 1(st) injection in both the experimental groups. The sero-protection data reported a 41.2-65.6% response on the 30(th) d after the 1(st) injection and reached 100% on the 60(th) d. Descriptive statistical analysis showed a geometric mean titer value of 13.77 mIU/mL in the test (BEVAC) group and 10.95 mIU/mL in the commercial control (ENGERIX-B) group on the 30(th) d after the 1(st) injection. The response on the 60(th) d showed a geometric mean titre value (GMT) of 519.84 mIU/mL in the BEVAC group and 475.46 mIU/mL in the ENGERIX-B group. On the 90(th) d, the antibody titer response was observed to be 2627.58 mIU/mL in the BEVAC group and 2272.72 mIU/mL in the ENGERIX-B group. Two subjects in each group experienced pains at injection site after the first vaccination. A total of six subjects in both groups experienced a solicited adverse reaction, which included pains, swelling and redness at the injection site, three subjects in the group-B had a pain at the injection site after the third dose. No other serious adverse events occurred and no dose-related local or general symptoms were observed during the study.

CONCLUSION

The vaccine is safe, efficacious and immunogenic in comparison with the well documented ENGERIX-B.

摘要

目的

采用加速程序确定国产重组乙型肝炎疫苗的安全性和有效性，并强调在预防乙型肝炎病毒感染传播方面的社会意识和承诺。

方法

本研究为多中心、双盲、随机（3:1）研究，采用三剂疫苗免疫程序（10岁及以上者20μg，10岁以下者10μg），分别于第0、30和60天接种。共纳入166名受试者（87名男性和76名女性，年龄5 - 35岁）。主要观察指标为免疫原性和安全性评估。

结果

两个实验组在首次注射后第30天均观察到100%的血清学转换反应。血清保护数据显示，首次注射后第30天的反应率为41.2% - 65.6%，第60天达到100%。描述性统计分析显示，首次注射后第30天，试验组（BEVAC）的几何平均滴度值为13.77 mIU/mL，商业对照组（ENGERIX - B）为10.95 mIU/mL。第60天的反应显示，BEVAC组的几何平均滴度值（GMT）为519.84 mIU/mL，ENGERIX - B组为475.46 mIU/mL。第90天，BEVAC组的抗体滴度反应为2627.58 mIU/mL，ENGERIX - B组为2272.72 mIU/mL。每组各有2名受试者在首次接种后出现注射部位疼痛。两组共有6名受试者出现了预期的不良反应，包括注射部位疼痛、肿胀和发红，B组有3名受试者在第三次接种后出现注射部位疼痛。研究期间未发生其他严重不良事件，也未观察到与剂量相关的局部或全身症状。