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首页> 外文期刊>World Journal of Gastroenterology >Immune response to an indigenously developed r-hepatitis B vaccine in mixed population: study of an accelerated vaccination schedule.
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Immune response to an indigenously developed r-hepatitis B vaccine in mixed population: study of an accelerated vaccination schedule.

机译：对混合人群中本地开发的乙型肝炎乙型肝炎疫苗的免疫反应：加速接种时间表的研究。

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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.
机译：目的：以加速的时间表确定本土研发的乙型肝炎疫苗的安全性和有效性，并强调社会意识和致力于预防乙型肝炎病毒感染扩散的承诺。方法：该研究是一项多中心，双盲，随机（3：1）研究，在d 0、30和d时使用三剂疫苗免疫方案（10岁以上者20杯，10岁以下者10杯）。 60.纳入166名受试者（男87名，女性76名，年龄5至35岁）。主要结果指标是评估免疫原性和安全性。结果：两个实验组在第1次注射后第30天观察到100％的血清转化反应。血清保护数据报告，在第1次注射后第30天，有41.2-65.6％的反应，在第60天达到了100％。描述性统计分析显示，第1次注射后第30天，测试（BEVAC）组的几何平均滴度为13.77 mIU / mL，商业对照组（ENGERIX-B）组的几何平均滴度为10.95 mIU / mL 。第60天的反应显示，BEVAC组的几何平均滴度（GMT）为519.84 mIU / mL，而ENGERIX-B组的为475.46 mIU / mL。在第90天，在BEVAC组中观察到抗体滴度响应为2627.58 mIU / mL，而在ENGERIX-B组中观察到抗体滴度响应为2272.72 mIU / mL。初次接种疫苗后，每组两名受试者在注射部位感到疼痛。两组中总共有六名受试者经历了引起的不良反应，包括注射部位的疼痛，肿胀和发红，B组中的三名受试者在第三剂注射后出现了注射部位的疼痛。在研究过程中未发生其他严重不良事件，也未观察到剂量相关的局部或一般症状。结论：与充分证明的ENGERIX-B相比，该疫苗安全，有效且具有免疫原性。

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