Hepatitis B vaccine: evidence confirming lack of AIDS transmission.

Hepatitis B vaccine acceptance in the US has been seriously hindered by concerns regarding possible acquired immunodeficiency syndrome (AIDS) transmission from the vaccine. The recent identification of a retrovirus as the etiologic agent in AIDS has enabled direct laboratory measurement of virus inactivation nucleic acid presence and serologic evidence of infection. 1st the effect of hepatitis B vaccine inactivation processes on the AIDS virus and 2 other human retroviruses (human T-lymphotropic virus (HTLV) I and II) was studied. No residual virus was detected in cultured cell materials treated with formalin or urea while material treated with pepsin at pH 2 did have residual virus present. Heat an inactivation step used in vaccines manufactured outside the US has also been shown to inactivate the AIDS virus. The 2nd approach attempted to detect AIDS-related nucleic acid sequences through dot blot hybridization analysis of the vaccine with an AIDS virus deoxyribonucleic acid probe. The vaccine contained to detectable AIDS virus-related sequences. The 3rd approach attempted to detect seroconversions to AIDS antibodies in paired sera of hepatitis B vaccine recipients. No seroconversions were noted in 19 subjects who received vaccine manufactured from plasma pools that contained plasma of homosexual men. Finally epidemiologic approaches were used to detect an association between hepatitis B vaccination and AIDS. Of the 68 AIDS cases reported among the 700000 US recipients of hepatitis B vaccine at least 65 have occurred in individuals with known AIDS risk factors. This information should remove a major impediment to acceptance of hepatitis B vaccine.