title: Comparison of long-term immunogenicity (23 years) of 10 μg and 20 μg doses of hepatitis B vaccine in healthy children.
abstract: To compare the long-term immunogenicity and seroprotection rates in healthy children following 23 years of vaccination with 10 μg or 20 μg doses of plasma-derived hepatitis B vaccine, we revisited all participants from our previous randomized controlled trial. At year 23, 81 participants were tested for HBV serological markers and HBV-DNA, and a booster dose was given to those with anti-HBs titer < 10 mIU/mL. After eliminating the interference of a Year 11 booster dose and vaccines received outside of the trial, around 50% of participants still maintained anti-HBs titers ≥ 10 mIU/mL in both 10 μg and 20 μg groups (p > 0.05). The peak immune response of vaccination (anti-HBs antibody levels at 12 mo after 1st vaccine dose) and Year 11 anti-HBs levels were significantly associated with Year 23 seroprotection rates. Most of the participants in both groups, regardless of their prior immune status, developed a rapid and robust anamnestic antibody response after the booster dose at year 23. No case of clinically significant HBV infection was observed during the entire study period of 23 y with only one transient HBsAg seroconversion in 10 μg vaccine group. We concluded that seroprotection provided by 10μg or 20 μg doses of hepatitis B vaccine persists for 23 years in more than half of vaccinated individuals in highly HBV-endemic areas, irrespective of 10 μg or 20 μg vaccine doses. Future studies with larger sample sizes comparing long-term efficacy of various doses of plasma-derived and recombinant HBV vaccines are recommended.
authors.affiliation: Department of Epidemiology and Biostatistics; Xi'an Jiaotong University College of Medicine, Xi'an, Shaanxi, China.
authors.forename: Qian
authors.initials: Q
authors.lastname: Wu
authors.forename: Gui-hua
authors.initials: GH
authors.lastname: Zhuang
authors.forename: Xue-liang
authors.initials: XL
authors.lastname: Wang
authors.forename: Tie-jun
authors.initials: TJ
authors.lastname: Hou
authors.forename: Dimpy P
authors.initials: DP
authors.lastname: Shah
authors.forename: Xiao-li
authors.initials: XL
authors.lastname: Wei
authors.forename: Li-rong
authors.initials: LR
authors.lastname: Wang
authors.forename: Min
authors.initials: M
authors.lastname: Zhang
mesh_terms: D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D006801:Humans; D007156:Immunologic Memory; D008137:Longitudinal Studies; D008297:Male
chemical_list: D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines