title: A collaborative study to establish the International Reference Reagent for hepatitis B vaccine containing plasma-derived hepatitis B surface antigen.
abstract: A collaborative study was conducted to establish a suitable international reference reagent for hepatitis B vaccine for use in immunogenicity assays. The limiting dilution required to induce antibodies in 50% of the test animals was determined for the proposed international reference reagent and three other plasma-derived hepatitis B vaccines. The minimum antigenic dose of these preparations varied widely (100-fold range) between laboratories. However, the expression of potencies of vaccines relative to the proposed International Reference Reagent reduced the variation between laboratories to within a 10-fold range. The reference reagent is intended for use in assays of hepatitis B vaccines in mouse (or guinea-pig) immunogenicity studies. For products made by different procedures, clinical trials in humans are necessary to establish a correlation between the immunogenic potency in animals and man.
authors.affiliation: National Institute for Biological Standards and Control, Herts, UK.
authors.forename: M
authors.initials: M
authors.lastname: Ferguson
authors.forename: V
authors.initials: V
authors.lastname: Seagroatt
authors.forename: G C
authors.initials: GC
authors.lastname: Schild
mesh_terms: D004355:Drug Stability; D004797:Enzyme-Linked Immunosorbent Assay; D006514:Hepatitis B Surface Antigens / Q000032:analysis* / Q000276:immunology; D017325:Hepatitis B Vaccines; D007118:Immunoassay; D007136:Immunoglobulins / Q000032:analysis; D007202:Indicators and Reagents; D011863:Radioimmunoassay; D012015:Reference Standards; D014761:Viral Hepatitis Vaccines / Q000592:standards*
chemical_list: D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D007136:Immunoglobulins; D007202:Indicators and Reagents; D014761:Viral Hepatitis Vaccines