ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the safety and immunogenicity of the Bilive(TM) combined hepatitis A and hepatitis B vaccine in healthy children.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSION</b>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.</p>
Subject(s)
Child , Child, Preschool , Female , Humans , Infant , Male , Dose-Response Relationship, Immunologic , Hepatitis A Vaccines , Allergy and Immunology , Hepatitis B Vaccines , Allergy and Immunology , Immunization Schedule , Vaccines, Combined , Allergy and ImmunologyABSTRACT
Objective To evaluate the immunogenicity, safety, stability and consistency of three consecutive lots of a inactivated hepatitis A vaccine (Healive(R)). Methods A double-blind, randomized and controlled clinical trial was conducted in healthy volunteers aged from 1 to 8 years. Totally, 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive(R) or an licensed control vaccine in 0 and 6th month. Safety was assessed through a 30 minutes and three days observation,thereafter. Anti-HAV titers were determined on the 1st, 6th and 7th month after the vaccination.Results Seroconversion rate of four groups were all 100% by the end of the schedule while GMTs of Healive(R) were 3237.06-3814.14 mIU/ml but were not significantly different. GMT of control vaccine was 1467.49 mIU/ml. Healive(R) and control vaccine were well tolerated with 1%-5% incidence of overall adverse reactions in which most of them were mild and moderate. No severe adverse reaction was reported.Conclusion The three consecutive lots of Healive(R) were well consistent as indicated by immunogenicity and safety while immunogenicity was better than the vaccine used as control.