Potency test of hepatitis B vaccines by the parallel line assay method in mice.
Adequate conditions for the potency test of hepatitis B (HB) vaccines in mice were looked for. Preliminary tests showed that BALB/c female mice of 5 weeks of age are adequate for the test. An immunization period of 5 weeks was found satisfactory for the test. Under these conditions, mice were immunized with each of serial dilutions of the test vaccine and a reference vaccine. The use of the parallel line assay method and the expression of the potency relative to that of the reference vaccine gave a reliable estimate of the potency of HB vaccine.
D000818:Animals; D004306:Dose-Response Relationship, Immunologic; D006510:Hepatitis B Antibodies / Q000096:biosynthesis*; D006515:Hepatitis B virus / Q000276:immunology*; D051379:Mice; D008815:Mice, Inbred Strains; D014611:Vaccination; D014765:Viral Vaccines / Q000592:standards*
D006510:Hepatitis B Antibodies; D014765:Viral Vaccines