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Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China

Wednesday, 16th of March 2016

Vaccine

Volume 34, Issue 8, 17 February 2016, Pages 1034–1039

Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China

doi:10.1016/j.vaccine.2016.01.018

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Highlights

• 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%.

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 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%.

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.