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題 名 | Immunogenicity and Reactogenicity of Two Recombinant Hepatitis B Vaccines in 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 |
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作 者 | 陳志成; 張美惠; 李宏昌; 涂醒哲; | 書刊名 | 中華民國小兒科醫學會雜誌 |
卷 期 | 40:3 民88.05-06 |
頁 次 | 頁157-160+201 |
分類號 | 414.82 |
關鍵詞 | 劑數; B型肝炎疫苗; 免疫力; 副作用; Hepatitis B vaccine; Immunogenicity; Adverse reaction; Dose; |
語 文 | 英文(English) |
中文摘要 | 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,都含有同樣20μg的B型肝炎表面抗原(HBsAg)。但HBV-NF中的佐劑是phenoxythanol,不同於Engerix-B中的佐劑thiomersa1。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Engenrix-B的血清保護力(定義為anti-HBs濃度大於10mIU/ml),在第一個月分別是34.5%和44.3%(p=0.28)。施打第二劑後,HBV-NF和Engenrix-B的血清保護力,分別上升到90.9%,和93.4%(p=0.43)。兩種疫苗的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足夠的免疫效果。這也許是考慮大規模B型肝炎疫苗接種時,降低費用的不錯選擇。 |
英文摘要 | 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 20μg 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 liters of both vaccines displayed no significant difference at month 1, 6, and 7. Following the second dose of vaccine, the seroprotection liter (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. |
本系統中英文摘要資訊取自各篇刊載內容。