Objective To evaluate the immune efficacy and safety of multi-lots hepatitis B vaccines(YDV)derived from yeast on children with different immune schedules.
Methods 1564 of 6 to 12 years old healthy children were randomly divided into 17 groups selected athenan, Liaoning, Shandong and Sichuan province, whose HBsAg, anti-HBs, anti-HBc were all negative, vaccinated with 10 lots of YDV according to 0, 1, 6 or 0, 1, 2 month schedule.Test serum anti-HBs at 3, 7, 12, 24, 36, 48 and 60 months after the first dose.
Results No serious side effects were reported.At one month after the 3 doses(T7), seroprotective rates of anti-HBs for all 17 groups were all above 90%.The range of mean geometrictitres (GMT)of anti-HBs was from 96.04-619.01IU/L.The average of seroprotective for 0, 1, 6 and 0, 1, 2 group were 97.34% and 99.13%, with lower noresponse rates(2.66%, 0.87%).Follow-up study showed that anti-HBs declined rapidly, but slowly for seroprotective rate.GMT of anti-HBs of 0, 1, 6 group significantly higher than that of 0, 1, 2 group (305.27 vs 115.05 IU/L, P < 0.01).At 3 to 4 years after the first dose, anti-HBs GMT and ser oprotective rates of 0, 1, 6 and 0, 1, 2 group were at the same level(P > 0.05).
Conclusion YDV was safety and immunogenicity to vaccinate children.
DownLoad: