The Safety of the Hepatitis B Vaccine
Inactivation of the AIDS Virus During Routine Vaccine Manufacture
- Donald P. Francis, MD;
- Paul M. Feorino, PhD;
- Steven McDougal, MD;
- Donna Warfield;
- Jane Getchell, PhD;
- Cy Cabradilla, PhD;
- Myron Tong, MD;
- William J. Miller, MS;
- Loren D. Schultz, PhD;
- Fred J. Bailey;
- William J. McAleer, PhD;
- Edward M. Scolnick, MD;
- Ronald W. Ellis, PhD
- From the Divisions of Viral Diseases and Host Factors, Center for Infectious Diseases, Centers for Disease Control, Atlanta (Drs Francis, Feorino, McDougal, Getchell, and Cabradilla and Ms Warfield); the Liver Center, Huntington Memorial Hospital, Pasadena, Calif (Dr Tong); and the Department of Virus and Cell Biology, Merck Sharp & Dohme Research Laboratories, West Point, Pa (Drs Schultz, McAleer, Scolnick, and Ellis and Messrs Miller and Bailey).
Abstract
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.
(JAMA 1986;256:869-872)
Footnotes
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Reprint requests to Virology Section, Centers for Disease Control, Bldg 7-5B 47, Atlanta, GA 30333 (Dr Feorino).
