Objective: To assess the feasibility of the 10 microg recombination yeast hepatitis B vaccine in the expanded applicable population group aged 5 - 18.
Methods: 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.
Results: 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).
Conclusion: 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.