THE SAFETY OF THE HEPATITIS-B VACCINE - INACTIVATION OF THE AIDS VIRUS DURING ROUTINE VACCINE MANUFACTURE
THE SAFETY OF THE HEPATITIS-B VACCINE - INACTIVATION OF THE AIDS VIRUS DURING ROUTINE VACCINE MANUFACTURE
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DOI：
10.1001/jama.256.7.869
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发表时间：
1986-08-15
影响因子：
120.7
通讯作者：
ELLIS, RW
中科院分区：
文献类型：
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作者：
FRANCIS, DP;FEORINO, PM;ELLIS, RW
在美国，一种乙型肝炎疫苗（Heptavax-B）已获得许可用于预防乙型肝炎病毒感染。尽管这种疫苗在对照试验中已被证明非常有效且耐受性良好，并且已被推荐用于有感染乙型肝炎病毒风险的人，但许多人因担心感染获得性免疫缺陷综合症（艾滋病）而不愿接种疫苗。在本研究中，我们证明（1）Heptavax-B 生产中使用的三个灭活步骤中的每一个都可以独立灭活艾滋病病毒高滴度制剂的感染性； (2) 乙肝疫苗接种者不会产生艾滋病病毒抗体； (3)乙肝疫苗中未检测到与艾滋病病毒相关的核酸。这些观察结果清楚地表明，接种目前可用的乙型肝炎疫苗不会带来感染艾滋病的明显风险。
In the United States, one hepatitis B vaccine (Heptavax-B) has been licensed for the prevention of hepatitis B virus infections. Even though this vaccine has been shown to be highly effective and well tolerated in controlled trials and has been recommended for use in those at risk for acquiring infection by hepatitis B virus, many individuals have been reluctant to be immunized for fear of contracting acquired immunodeficiency syndrome (AIDS). In this study, we demonstrate that (1) each of the three inactivation steps used in the manufacture of Heptavax-B independently will inactivate the infectivity of high-titered preparations of the AIDS virus; (2) recipients of the hepatitis B vaccine do not develop antibodies to the AIDS virus; (3) the hepatitis B vaccine does not contain detectable levels of nucleic acids related to the AIDS virus. These observations clearly demonstrate that vaccination with the currently available hepatitis B vaccine poses no demonstrable risk for acquiring AIDS.