Development and chimpanzee testing of a vaccine against human hepatitis B.
Highly purified hepatitis B virus surface antigen (Australia antigen) purified by physical and chemical procedures from infected human plasma was used to prepare hepatitis B vaccine. The purified antigen was treated with formalin and the vaccine was tested exhaustively for safety by ordinary procedures and additionally in marmosets (for live hepatitis B virus). The vaccine was highly potent, inducing antibody in guinea pigs, grivet monkeys, and chimpanzees given three doses of vaccine containing up to 20 mug of hepatitis B antigen per dose. A protective efficacy trial was carried out in chimpanzees that were given three doses of vaccine subcutaneously and then challenged intravenously with 1000 chimpanzee infectious doses of human hepatitis B virus. All of five unvaccinated control animals developed hepatitis B virus antigenemia following challenge and all of six vaccinated animals were protected, including one animal that had failed to develop detectable antibody following vaccination.
D000818:Animals; D000914:Antibodies, Viral / Q000096:biosynthesis; D006168:Guinea Pigs; D000882:Haplorhini; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000096:biosynthesis; D006511:Hepatitis B Antigens; D006515:Hepatitis B virus / Q000276:immunology; D002679:Pan troglodytes; D014612:Vaccines
D000914:Antibodies, Viral; D006510:Hepatitis B Antibodies; D006511:Hepatitis B Antigens; D014612:Vaccines