Study on the Preparation of Hepatitis B-BCG Combined Vaccine

To prepare the Hepatitis B-BCG combined vaccine, the hepatitis B surface antigen( HBsAg)was prepared by genetic engineering technique and BCG was produced using routine biological technique, then the final product of the hepatitis B-BCG combined vaccine was processed by freeze-drying. The stability and efficacy on freeze-dry antigen were also studied .The immune response, safety,partial toxicity,and allergy were tested using different animals. Results found that the freeze-drying technique had no effect on antigen; also no significant difference in the relative efficacy among the combined vaccine or BCG(P0.05);The Hepatitis B vaccine was the same (P0.05); The safety in hepatitis B-BCG combined vaccine group was accorded with that in BCG group, and the tuberculosis was not seen. The process in pathological changes of hepatitis B-BCG combined vaccine group and BCG group was similar. HBsAg did not strengthen the inflammation reaction caused by BCG. In addition the allergy was not found in experment.