[Safety and immunogenicity of combined hepatitis A and hepatitis B vaccine according to 0 and 6 months schedule in healthy children].
OBJECTIVE
To evaluate the safety and immunogenicity of the Bilive(TM) combined hepatitis A and hepatitis B vaccine in healthy children.


METHODS
A total of 116 healthy children aged 1 - 10 years, who, without history of hepatitis A vaccine vaccination and anti-HAV negative, had completed the full immunization of hepatitis B vaccine were recruited in city of Changzhou in Jiangsu province. The Bilive(TM) combined hepatitis A and hepatitis B vaccine was administered according to a two-dose schedule (0, 6 months). The dosage was 250 U for hepatitis A antigen and 5 microg for hepatitis B surface antigen. The potential adverse effects were observed within 72 hours after vaccination. The serum samples were collected for the testing of anti-HAV and anti-HBs at month 1, 6 and 7 after initial dose.


RESULTS
The local and systemic adverse reactions after immunization were slight and temporary. The rates of local and systemic adverse reactions were 12.1% (14/116) and 6.0% (7/116). The sero-conversion rates of HAV were from 92.9% (92/99) to 100.0% (101/101) and the geometric mean titers (GMT) ranged from 47.0 mIU/ml to 2762.3 mIU/ml 1, 6, 7 months after initial dose. The sero-protection rate of HBV was 86.1% (87/101) before vaccination and came up to 100.0% (101/101) one month after initial dose, and the GMTs of HBV were from 894.3 mIU/ml to 3314.3 mIU/ml 1, 6, 7 months after initial dose.


CONCLUSIONS
The Bilive(TM) combined hepatitis A and hepatitis B vaccine has good safety and immunogenicity in healthy children who had preexisting immunity to hepatitis B virus.
Wang
Ya-Long
YL
Changzhou Center for Disease Control and Prevention, Changzhou 213003, China.
Chen
Wen-Yu
WY
Xu
Wen-Guo
WG
Wang
Xu
X
Liu
Yan
Y
Wu
Jian-Fang
JF
Chen
Jiang-Ting
JT
D002648:Child; D002675:Child, Preschool; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D022362:Hepatitis A Vaccines / Q000009:adverse effects / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology
D022362:Hepatitis A Vaccines; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined