[The study on the 0, 12 month vaccination schedule' of Healive inactivated hepatitis A vaccine in children].
OBJECTIVE
To evaluate the safety, immunogenicity and fit dosage of Healive inactivated hepatitis A vaccine (HAV) in children.


METHODS
A total of 85 susceptible aged 4 - 10 years with HAV seronegative children, had been enrolled from two adjacent villages in a county. The volunteers were randomized allocated into two groups and to receive a priming dose of 250 U/0.5 ml/dose or 500 U/1.0 ml/dose of Healive vaccine, produced by Sinovac Biotech Co, Ltd. A booster of the same dose was given at 12th month. Local and systemic side effects were examined and seroconversion rate as well as geometric mean titers of anti-HAV antibody were tested at 3-week, 12-month after the primary dose and at 1 month after the booster dose.


RESULTS
The vaccine was well tolerated in both groups. At 21 days after the primary dose, the seroconversion rates were 94.4%, 100.0% and geometric mean titers (GMT) were 195 mIU/ml and 370 mIU/ml in 250 U and 500 U groups respectively. At 12 months after the primary dose, the seroconversion rate of anti-HAV was 100.0%, and GMT raised to 361 mIU/ml, 456 mIU/ml (P > 0.05) respectively. One month after the booster dose, GMT raised to 14 893 mIU/ml, 21 696 mIU/ml.


CONCLUSIONS
GMT of the 0, 12 month schedule was higher than other schedule after the booster vaccination. The Healive inactivated vaccine can be used for emergency vaccination. The Healive inactivated vaccine produced by Sinovac Company Ltd was safe and highly immunogenic. Two hundred and fifty U/dose was considered appropriate for children.
Ren
Yin-hai
YH
Health and Anti-eqidemic Station of Pingshan County, Pingshan 050400, China.
Chen
Jiang-ting
JT
Wu
Wen-ting
WT
Gong
Xue-jie
XJ
Zhang
Yu-cheng
YC
Xue
Wei-hua
WH
Ren
Yi-feng
YF
Han
Lian-jun
LJ
Kang
Wen-xue
WX
Li
Sheng-ping
SP
Liu
Chong-bai
CB
D002648:Child; D002675:Child, Preschool; D004306:Dose-Response Relationship, Immunologic; D004334:Drug Administration Schedule; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control; D035922:Hepatitis A Antibodies / Q000032:analysis*; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000276:immunology*
D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D015164:Vaccines, Inactivated