ABSTRACT
Two experimental lots of hepatitis B vaccine were prepared by purification of HBsAg from human plasma, inactivation at 100 degrees C for 2 min and at 37 degrees C for 72 hours with formalin in a concentration of 1:4000. The former lot comprises purified HBsAg (40 mg/ml) adsorbed with 0.32 mg % Al(OH)3, the latter consists of purified HBsAg stabilized with 0.1% human albumin and adsorbed with 1 mg% Al(OH)3. The immune response after vaccination with the first lot was observed in 54.54% of the vaccinees. The second vaccine after 3 administrations of 80 micrograms/ml each produced a very good primary and a very good secondary immune response. Both vaccines are nonreactogenic and well tolerated by the vaccinees.
Subject(s)
Hepatitis B/prevention & control , Viral Hepatitis Vaccines/administration & dosage , Animals , Drug Evaluation , Drug Evaluation, Preclinical , Guinea Pigs , Hepatitis B/immunology , Hepatitis B Antibodies/analysis , Hepatitis B Surface Antigens/immunology , Hepatitis B Surface Antigens/isolation & purification , Humans , Immunity, Cellular , Immunization , Immunization, Secondary , Time Factors , Viral Hepatitis Vaccines/immunology , Viral Hepatitis Vaccines/isolation & purificationABSTRACT
Immune response to hepatitis type A antigen (HAAg) was measured by the passive hemagglutination test (PHA) and by the immune adherence test (IAHA). Specific antibodies found by PHA are of the IgM class which indicates a recent exposure to hepatitis A virus. The antibodies found by IAHA reflect the level of postinfectious immune status. The antibody curve is highest in the age group of 30--49 years (95%). The above-mentioned serological tests were carried out with purified by gel filtration in Sepharose 6B Botevgrad faecal morphologically consisting of 27 nm particles with the buoyant density in CcCl of 1.40 g/ml. The same particles were aggregated with sera positive for antibody to hepatitis type A antigen in immune electron microscopy (IEM).
