Characterization and immune effect of the hepatitis B-BCG combined vaccine for using a needle innoculation.

ABSTRACT

OBJECTIVE: To prepare the hepatitis B-Mycobacterium bovis Bacillus Calmette-Guérin combined vaccine (HB-BCG combined vaccine) and resolve a needle problem of the two kinds of hepatitis B vaccine (HB vaccine) and M. bovis Bacillus Calmette-Guérin (BCG) for the innoculation. METHODS: The hepatitis B surface antigen (HBsAg) was prepared by the genetic engineering technique, BCG was produced using routine biological technique, and then the finished products of the HB-BCG combined vaccine were processed on the above foundation. The content of HBsAg was measured by Enzyme linked immunosorbent assay (ELISA), the immune effect of BCG was detected by purified protein derivative (PPD) test. Cellular immune response, safety, partial poison and allergy were tested. The stability of HB-BCG combined vaccine was detected by ELISA and viable count method. RESULTS: The two kinds of antigens (HBsAg and BCG) had good compatibility. The comparison on immune effects of HB-BCG combined vaccine and BCG showed no significant difference. The comparison on immune effects of HB-BCG combined vaccine group (first dose for HB-BCG Combined vaccine, second and third dose for HB vaccine) and HB vaccine group (three dose all for HB vaccine) demonstrated that anti-HBs levels of the HB-BCG combined vaccine group were higher than that of HB vaccine group. No statistical significance was observed between the combined vaccine group and HB vaccine group after three doses immunization schedules. The results of safety in HB-BCG combined vaccine group accorded with that of BCG group, it had been not found the pathological changes of the tuberculosis. The characteristic and process in pathological changes of HB-BCG combined vaccine group and BCG group were similar in the partial poison test. HBsAg did not strengthen the inflammation reaction caused by BCG. Systemic allergy had not been found. The HB-BCG combined vaccine was stable in 2 years. CONCLUSION: The immune effects of the HB-BCG combined vaccine were not lower than the two kinds of single dose vaccine, it had good safety.