Immunogenicity and Reactogenicity of Two Recombinant Hepatitis B Vaccines in Healthy Adolescents on Two-dose Healthy Adolescents on Two-dose Schedule

兩種基因合成B型肝炎疫苗在健康青少年施打兩劑的免疫力和副作用反應

陳志成(Chih-Cheng Chen) ； 張美惠(Mei-Hwei Chang) ； 李宏昌(Hung-Chang Lee) ； 涂醒哲(Shiing-Jer Twu) ； Assad Safary

《Acta Paediatrica Sinica》 40卷3期 (1999/06) Pp. 157-160

https://doi.org/10.7097/APS.199906.0157

摘要

本研究評估比較兩種基因合成B型肝炎疫苗的免疫力和副作用反應。新疫苗HBV-NF和目前已上市的疫苗Engerix-B，都念吸同樣20μg的B型肝炎表面抗原(HBsAg)。但HBV-NF中的佐劑是phenoxyethanol，不同於Engerix-B中的佐劑thiomersal。共有116位，年齡在12到18歲的健康青少年參加本研究。我們在第0和6個月，用肌肉注射疫苗在參加者的上臂三角肌上。然後在第1，6，7個月抽血，用放射性免疫法測量血清中的B型肝炎表面抗原的抗體(anti-HBs)濃度。結果發現HBV-NF和Engerix-B的血清保護力(定義爲anti-HBs濃度大於10mIU/ml)，在一個月分是34.5%和44.3%(p=0.28)。施打第二劑後，HBV-NF和Engerix-B的血清保護力，分別上昇到90.9%和93.4%(p=0.43)。兩種疫苗在局部和全身性副作用都很溫和，比例在3%到7%。兩者的血清濃度幾何平均值值和副作用比例，在第1，6，7個月也都沒有統計上的差異。本研究也發現0，6月兩劑的疫苗時程是安全又有跔的免疫效果。這也許是考虑大規模B型肝炎疫苗接種時，降低費用的不錯選擇。

關鍵字

B型肝炎疫苗 ； 免疫力 ； 副作用 ； 劑數

並列摘要

This is an open, randomized study to compare the immunogenicity and reactogenicity of two recombinant hepatitis B virus (HBV) vaccines. The HBV-NF is a new formulation with a new adjuvant phenoxyethanol which replaced the conventional adjuvant of a commercially available recombinant HBV vaccine (Engerix-B). These two vaccines had the same 20/μg hepatitis B surface antigen (HBsAg). They were administered to the deltoid muscle of 116 healthy adolescents, aged between twelve and eighteen years, according to the 0, 6-month schedule. Serum was taken at month 0, 1, 6, and 7. Antibody to HBsAg was tested by radioimmunoassay. Geometric mean titers of both vaccines displayed no significant difference at month 1, 6, and 7. Following the second dose of vaccine, the seroprotection titer (10 mIU/ml) rates at month 7 were 90.9% in HBV-NF and 93.4% in Engerix-B, respectively (p=0.43). The incidences of local and general adverse reactions were from 3% to 7% without significant difference between the two vaccines and the reactions were all mild and tolerable. Based on this study, regimens of this two-dose schedule proved to be safe and immunogenic, which may provide a cost-effective alternative for HBV mass vaccination program in adolescents.

並列關鍵字

hepatitis B vaccine ； immunogenicity ； adverse reaction ； dose