Francis D P, Feorino P M, McDougal S, Warfield D, Getchell J, Cabradilla C, Tong M, Miller W J, Schultz L D, Bailey F J
JAMA. 1986 Aug 15;256(7):869-72.
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 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; recipients of the hepatitis B vaccine do not develop antibodies to the AIDS virus; 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.
在美国，有一种乙肝疫苗（Heptavax - B）已获许可用于预防乙肝病毒感染。尽管这种疫苗在对照试验中已被证明高度有效且耐受性良好，并已被推荐用于有感染乙肝病毒风险的人群，但许多人因担心感染获得性免疫缺陷综合征（艾滋病）而不愿接种。在本研究中，我们证明了Heptavax - B生产过程中使用的三个灭活步骤中的每一个都能独立灭活高滴度艾滋病病毒制剂的传染性；乙肝疫苗接种者不会产生针对艾滋病病毒的抗体；乙肝疫苗不含可检测到的与艾滋病病毒相关的核酸水平。这些观察结果清楚地表明，接种目前可用的乙肝疫苗不会带来可证明的感染艾滋病的风险。
