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Volume 34, Issue 8, 17 February 2016, Pages 1034–1039
doi:10.1016/j.vaccine.2016.01.018
• To compare immunogenicity of HBV vaccine between 20 μg (0−1−6 month) and 60 μg (0−1 or 0−2 month) regimens in adults.
•No differences in seroprotection rates among three vaccine groups at month 7/2/3 or 12.
• The similar GMCs were observed in 20 μg (0−1−6 month) and 60 μg (0−2 month) groups at month 7/3.
• A higher GMC level was induced by 3-dose (20 μg) HBV vaccine than by 2-dose (60 μg) at month 12.
• All formulations of HBV vaccine were well tolerated with the incidence of adverse reactions <3%.
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.
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).
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 60 μg (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%.
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.
NCT02203357.
Corresponding authors. Tel.: +86 10 8280 2413; fax: +86 10 8280 2413.
ZZ Wang and MQ Li contributed equally to this article.
Copyright © 2016 Elsevier Ltd. All rights reserved.