A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults

Comparador activo: 20μg, 0-1-6

117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.

Biológico: Hepatitis B vaccine

Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.

Experimental: 60μg, 0-1

112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.

Biológico: Hepatitis B vaccine

Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.

Experimental: 60μg, 0-2

125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.

Biológico: Hepatitis B vaccine

Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.

Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults

The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.

The GMCs of anti-HBs antibody will be compared among the three vaccine groups.

Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults

The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.

The GMCs of anti-HBs will be compared among the three vaccine groups.

Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults

The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.

The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years.

Safety of HBV Vaccine Determined by Number of Participants With Adverse Events

Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.