[The immunogenicity and safety of 10 microg recombination yeast hepatitis B vaccine applied in expanded population]

To assess the feasibility of the 10 microg recombination yeast hepatitis B vaccine in the expanded applicable population group aged 5 - 18.

People with both HBsAg and anti-HBs negative were selected to take two-stage clinical experiment and the safety and immunogenicity were observed. Safety observation was conducted in 925 subjects, while 568 for immunogenicity. The observation group (aged 5 - 18) included 493 subjects, and (age > 18) 75 enrolled in control group. For the observation group, there were three sub-groups including a child group (141, aged 5 - 6), early youth group (177, aged 12 - 13), and youth group (175, aged 16 - 18). Both groups were administered with 10 microg recombination yeast hepatitis B vaccines with 3 doses at 0 month, 1st month, 6th month. To assess the immunogenicity, the vaccination reactions were observed during the following 4 weeks in order to assess the vaccine safety. The blood samples were taken during 4 - 6 weeks after fully vaccinated, and then anti-HBs were tested with RIA and analyzed by comparing the positive rate of anti-HBs, the geometric mean titer (GMT) and the protective rate between the two groups.

Both observation and control group didn't show any general reactions, adverse events following immunization (AEFI) or coincidental cases when observed at 0.5 h, 6 h, 24 h, 48 h, 72 h, 1 week, 2 weeks, 3 weeks, 4 weeks after being vaccinated. The result of serum test showed, the positive rates of child group, early youth group, youth group and control group were respectively 100.00% (141/141), 97.18% (172/177), 98.29% (172/175) and 89.33% (67/75); the GMTs of anti-HBs were respectively 440.28, 875.38, 467.80, 131.06 U/L; the protective rates were respectively 100.00% (141/141), 97.18% (172/177), 97.14% (170/175) and 86.67% (65/75). The positive rate, GMT and protective rate of the experimental group were all higher than that of control group (chi(2)(positive rate) = 12.77, 5.12, 7.99; t(GMT) = 3.89, 4.13, 5.91; chi(2)(protective rate) = 16.81, 8.60, 8.44; P < 0.05).

This vaccine could be expanded to 5 - 18 year-old population with safety and effectiveness, the positive rate and protective rate of anti-HBs were both higher than that of control group.