title: Comparison of the effect of two different doses of recombinant hepatitis B vaccine on immunogenicity in healthy adults.
abstract: The aim of this study was to evaluate the one-month immune response to 2 different doses (10 and 20 μg) of recombinant hepatitis B vaccine in adults aged 20-46 y. Subjects who were negative for hepatitis B surface antigen (HBsAg), hepatitis B antibody (anti-HBs), and hepatitis B core antibody (anti-HBc) were recruited. The participants were divided into 2 groups: group I received 3 doses of 10 μg hepatitis B vaccine at 0, 1 and 3 months, and group II received 3 doses of 20 μg at the same time points. The anti-HBs levels were measured one month after the third vaccination. Among 739 subjects, 62 (9.70%) were positive for HBsAg, and 317 subjects were eligible. The anti-HBs seroprotection rates (anti-HBs ≥ 10 mIU/mL was considered to indicate seroprotection) after the third vaccination were 88.05% and 94.06% in group I and group II respectively, and the geometric mean titers were 91.69 and 290.23 mIU/mL respectively. The difference in the seroprotection rate was not significant (χ(2) = 2.566, P > 0.05), but the GMT after the third dose was significantly lower for group I than for group II (F = 20.587, P < 0.05). Better responses were observed in young adults, especially in group I. In group I, the seroprotection rate and GMT were significantly higher in the 20-35 y group than in the 36-46 y group (P < 0.05); there was no significant difference compared to group II (P > 0.05). The hepatitis B vaccine has good immunological effect; the 20 μg dose can be used in adults aged 20-46 y and the 10 μg dose can be used in subjects aged 20-35 years, and it should be tested on a larger number of subjects before recommending it for adult routine vaccination.
authors.affiliation: a School of Medicine; Ningbo University ; Ningbo , China.
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.forename: Jun
authors.initials: J
authors.lastname: Yao
authors.forename: Huan
authors.initials: H
authors.lastname: Shan
authors.forename: Yongdi
authors.initials: Y
authors.lastname: Chen
authors.forename: Zheng-gang
authors.initials: ZG
authors.lastname: Jiang
authors.forename: Jing-jing
authors.initials: JJ
authors.lastname: Ren
authors.forename: Kai-jin
authors.initials: KJ
authors.lastname: Xu
authors.forename: Bing
authors.initials: B
authors.lastname: Ruan
authors.forename: Shi-gui
authors.initials: SG
authors.lastname: Yang
authors.forename: Bing
authors.initials: B
authors.lastname: Wang
authors.forename: Tian-sheng
authors.initials: TS
authors.lastname: Xie
authors.forename: Qian
authors.initials: Q
authors.lastname: Li
mesh_terms: D000328:Adult; D000367:Age Factors; D002681:China; D006510:Hepatitis B Antibodies / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D006801:Humans; D008875:Middle Aged; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000276:immunology; D055815:Young Adult
chemical_list: D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic
keywords: adults; hepatitis B virus (HBV); immunogenicity effect; recombinant hepatitis B vaccine