[Immediate immunological effect of China-made recombinant hepatitis B vaccine expressed by transgenic Chinese hamster ovary cell line].
OBJECTIVE: To understand the protective efficacy of China-made recombinant hepatitis B vaccine expressed by transgenic Chinese hamster ovary cell line among newborns. METHODS: 2 969 newborns in seven townships in Zhengding County, Hebei Province, were vaccinated with 10 microgram x 3 doses of China-made recombinant hepatitis B vaccine expressed by transgenic Chinese hamster ovary cell line according to the 0 - 1 - 6 month schedule from 1 January 1997 to 31 August 1999. The newborns were to be vaccinated with the first dose within 24 hours after they were born. 1906 serum samples were selected in April 2000 to detect the hepatitis B infection markers, including HBsAg, HBsAb and HbcAb by RIA kits. RESULTS: 2 783 of the 2 969 newborns (93.74%) were vaccinated with three doses, 2 833 of them (95.42%) were vaccinated with the first dose within 24 hours after they were born. The anti-HBs positive rate was 98.25% (S/N >/= 2.1) or 94.26% (S/N >/= 10.0), and the geometric mean titer (GMT) value of antibody was 77.64 within the first year after the whole course vaccination. Then the antibody level decreased gradually with the lapse of time. The HBsAb positive rate was 92.31% (S/N >/= 2.1) or 68.96% (S/N >/= 10.0), and GMT value was 22.86 within the third year after vaccination. The HBsAg positive rates remained less than 1%, the HBcAb positive rates and HBV infection rates remained 1% approximately 3% within 3 years after vaccination. CONCLUSION: The protective efficacy of China-made recombinant hepatitis B vaccine is satisfactory.