Zhen-Zi Wang1, Ming-Qiang Li2, Ping Wang2, Zhen-Xing Yang2, Lin Wei2, Ying Zeng3, Yan-Ping Li4, Ling Yan1, Xue-En Liu5, Hui Zhuang6. 1. Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China. 2. Liuzhou Municipal Center for Disease Control and Prevention, Liuzhou 545007, Guangxi, China. 3. Shenzhen Kangtai Biological Products Co., LTD., Shenzhen 518057, Guangdong, China. 4. Guangxi Provincial Centers for Disease Control and Prevention, Nanning 530028, Guangxi, China. 5. Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China. Electronic address: xueenliu@bjmu.edu.cn. 6. Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China. Electronic address: zhuangbmu@126.com.
Abstract
OBJECTIVES: To compare immunogenicity of hepatitis B vaccine between the standard 3-dose (20 μg) and 2-dose with higher-dosage (60 μg) regimens in healthy young adults and evaluate the safety profile. METHODS: A randomized, parallel-group clinical trial was conducted among healthy young adults aged 18-25 years. Subjects were randomly assigned to three groups. One group was administered hepatitis B vaccine with the standard regimen of 0-1-6 month (20 μg) and other groups were immunized with regimens of 0-1 or 0-2 month (60 μg) respectively. Serum samples were collected at 1 month after a series vaccination and 12 months after the first-dose inoculation for anti-HBs antibody measurement with a Chemiluminescent Microparticle ImmunoAssay (CMIA). RESULTS: The seroprotection rates in 20 μg (0-1-6 month), 60 μg (0-1 month) and 60 μg (0-2 month) groups were 100, 93.64 and 99.19% at month 7/2/3, and 100, 96.04 and 95.90% at month 12, respectively. There were no significant differences among three vaccine groups (p>0.05). The geometric mean concentration (GMC) of anti-HBs was significantly higher in 20 μg (0-1-6 month) group than that in 60 μg (0-1 month) group at month 7/2 (1847.99 vs. 839.27 mIU/ml, p=0.004), but was similar to that in 60μg (0-2 month) group at month 7/3 (1847.99 vs. 1244.80 mIU/ml, p=0.138). At month 12, the GMC in 20 μg (0-1-6 month) group was significantly higher than those of other groups (1456.63 vs. 256.30, 235.15 mIU/ml, respectively, p<0.001). The total incidence of injection-site or systemic adverse reactions was <3%. CONCLUSIONS: A 2-dose with higher-dosage hepatitis B vaccine regimens are comparable to the standard 3-dose regimen in terms of immunogenicity except a relatively rapid decline in GMC levels which are associated with the longevity of protection. All formulations of hepatitis B vaccine were well tolerated. CLINICALTRIALS.GOV IDENTIfiER: NCT02203357.
RCT Entities:
OBJECTIVES: To compare immunogenicity of hepatitis B vaccine between the standard 3-dose (20 μg) and 2-dose with higher-dosage (60 μg) regimens in healthy young adults and evaluate the safety profile. METHODS: A randomized, parallel-group clinical trial was conducted among healthy young adults aged 18-25 years. Subjects were randomly assigned to three groups. One group was administered hepatitis B vaccine with the standard regimen of 0-1-6 month (20 μg) and other groups were immunized with regimens of 0-1 or 0-2 month (60 μg) respectively. Serum samples were collected at 1 month after a series vaccination and 12 months after the first-dose inoculation for anti-HBs antibody measurement with a Chemiluminescent Microparticle ImmunoAssay (CMIA). RESULTS: The seroprotection rates in 20 μg (0-1-6 month), 60 μg (0-1 month) and 60 μg (0-2 month) groups were 100, 93.64 and 99.19% at month 7/2/3, and 100, 96.04 and 95.90% at month 12, respectively. There were no significant differences among three vaccine groups (p>0.05). The geometric mean concentration (GMC) of anti-HBs was significantly higher in 20 μg (0-1-6 month) group than that in 60 μg (0-1 month) group at month 7/2 (1847.99 vs. 839.27 mIU/ml, p=0.004), but was similar to that in 60μg (0-2 month) group at month 7/3 (1847.99 vs. 1244.80 mIU/ml, p=0.138). At month 12, the GMC in 20 μg (0-1-6 month) group was significantly higher than those of other groups (1456.63 vs. 256.30, 235.15 mIU/ml, respectively, p<0.001). The total incidence of injection-site or systemic adverse reactions was <3%. CONCLUSIONS: A 2-dose with higher-dosage hepatitis B vaccine regimens are comparable to the standard 3-dose regimen in terms of immunogenicity except a relatively rapid decline in GMC levels which are associated with the longevity of protection. All formulations of hepatitis B vaccine were well tolerated. CLINICALTRIALS.GOV IDENTIfiER: NCT02203357.