[Abstract] To evaluate the safety and immunogenicity of a combined hepatitis A and hepatitis B vaccine（BiliveTM）in healthy adolescent volunteers.
[Author] SINOVAC BIOTECH CO., LTD.
[key words] Bilive
Objective: To evaluate the safety and immunogenicity of a combined hepatitis A and hepatitis B vaccine（BiliveTM）in healthy adolescent volunteers.
Method: In Guangxi province and Hebei province of China, adolescent volunteers were selected from 16 year-old to 20 year-old students of a senior high school. Those who were susceptible to HAV and HBV, HAV only, and HBV only were assigned to the following groups AB, A and B, respectively. Individuals in each group were vaccinated with three doses (0, 1 and 6 month schedule) of a combined hepatitis A and B vaccine, an inactivated hepatitis A vaccine and a recombined hepatitis B vaccine, respectively. The dosage was 500u hepatitis A antigen and 10ug 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 2 and 7 months after the initial dose.
Results: Localized and systemic adverse reactions after the primary immunization and the booster immunization were slight and temporary in the AB group, while the systemic adverse result was a low fever. Both of local and systemic adverse effects disappeared without treatment within 72 hours. The sero-conversion rate of HAV in AB and A group was 100% one month after 3 doses; the Geometric mean titer (GMT) was 22663mIU/ml and 23311mIU/ml respectively. The sero-conversion rate of HBV in AB and B group was 97.71% and 96.89% one month after 3 doses; the GMT was 107mIU/ml and 97mIU/ml respectively. There was no significant difference on sero-conversion and GMT among the combined group and control groups.
Conclusion: the combined hepatitis A and B vaccine (BiliveTM) has good tolerance, and the immunogenicity on both anti-HAV and anti-HBs was similar to that of separated components.
Original: SINOVAC BIOTECH CO., LTD.
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