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ABSTRACT
Background: The widely recommended standard schedule of hepatitis B vaccine for adults is months 0, 1 and 6, which takes 6 months to complete. Rapid completion of one vaccination schedule is important to adults because of its low compliance with follow-up doses. A new type of 60 μg Hepatitis B vaccine, made by Shenzhen Kangtai Biological Products Co., LTD., is originally recommended for low or non-responders. The objective of this clinical trial was to test whether this 60 μg hepatitis B vaccine could be used in primary immune population and what is its level of immunogenicity and safety compared with other hepatitis B vaccines.
Methods: This is a 2-center randomized controlled study. A total of 1169 healthy adults aged between 25 and 55 who tested negative for HBsAg, anti-HBs, and anti-HBc were eligible for the study and were enrolled from relatively fixed and stable sites, such as villages, schools and large enterprises et al in Xuanhua county in Hebei province and Huaibei county in Anhui province. They were randomized to group A (20 μg Engerix-B® with 0, 1, 6 month intervals), group B (20 μg Kangtai hepatitis B vaccine with 0, 1, 6 month intervals), group C (60 μg Kangtai hepatitis B vaccine with 0, 2 month intervals) and group D (20 μg Huabei hepatitis B vaccine made by recombinant DNA techniques in CHO cell with 0, 1, 6 month intervals). In group A, B and D, every study object's blood sample was collected in the second month after their final injection to test the anti-HBs levels; while in group C, the blood sample was collected in the second month after the first and the second injection to test the anti-HBs levels. Adverse events were collected after each dose to assess the vaccines' safety.
Results: The seroprotection rates were 93.17%, 97.23%, 93.54% and 98.98% respectively and the geometric mean titers (GMTs) were 1033.38 mIU/ml, 600.75 mIU/ml, 265.69 mIU/ml and 1627.05 mIU/ml in group A,B,C and D respectively. The difference of seroprotection rate among the 4 groups was statistically significant (χ2 = 17.26, P<0.05). The difference of titers of anti-HBs among the 4 groups was statistically significant (H = 162.42, P<0.05). BMI, age (older than 40) and smoking were the influence factors of anti-HBs levels on 60 μg hepatitis B vaccine.
Conclusion: 60 μg hepatitis B vaccine has a satisfactory safety and seroprotection rate in adult, It could be used in rapid adult hepatitis B immunization.
Abbreviations
| HBV | = | Hepatitis B Virus |
| HBsAg | = | Hepatitis B Surface Antigen |
| Anti-HBs | = | Hepatitis B Surface Antibody |
| HBeAg | = | Hepatitis B E Antigen |
| Anti-HBe | = | Hepatitis B E Antibody |
| Anti-HBc | = | Hepatitis B Core Antibody |
| Miu | = | Million International Units |
| EPI | = | Expanded Program on Immunization |
| BMI | = | Body Mass Index |
| GMTs | = | Geometric Mean Titers |
| CDC | = | Centers for Disease Control and Prevention |
Disclosure of potential conflicts of interest
No potential conflicts of interest were disclosed.
Acknowledgments
We acknowledge all the adults who took part in the study and all the personnel from the Beijing Center Disease Control and Prevention, Xuanhua District Center for Disease Control and Prevention and Huaibei District Center for Disease Control and Prevention who took part in collection of samples.
Funding
Funding for this work was provided by National Key Project on Infections Disease, 2012ZX10002001-003-003, 2012ZX10004-904.