Original articles
18-year follow-up study of a prospective randomized trial of hepatitis B vaccinations without booster doses in children

https://doi.org/10.1016/S1542-3565(04)00384-2Get rights and content

Background & Aims: The long-term immunogenicity and efficacy of hepatitis B virus (HBV) vaccination remain to be defined. We aimed to examine the long-term immunogenicity and efficacy of HBV vaccination with 3 different regimens over 18 years of follow-up. Methods: A total of 318 Chinese subjects receiving 3 different regimens of HBV vaccination (2-dose recombinant vs. 3-dose recombinant vs. 3-dose plasma-derived vaccines) without receiving a booster dose were recruited. The HBV serologic markers, including hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), were determined at yearly follow-up. After 18 years, 88 subjects were still being followed up. Results: Compared with subjects receiving the 2-dose regimen, subjects receiving the 3-dose regimens had a significantly higher geometric mean titer of anti-HBs and a higher proportion had anti-HBs titers ≥10 mIU/mL during the 18 years of follow-up. There were no differences in these 2 parameters between subjects receiving the 3-dose recombinant and subjects receiving the 3-dose plasma-derived vaccines. A total of 88 anamnestic responses were documented in 70 subjects (8 with initial anti-HBs titers <100 mIU/mL at 12 months and 7 with anti-HBs titers <10 mIU/mL before the anamnestic responses). No subject became positive for HBsAg. Three subjects had benign breakthrough HBV infection without leading to chronicity indicated by isolated anti-HBc positivity. Conclusions: There was less long-term immunogenicity associated with the 2-dose regimen when compared with the 3-dose regimens of HBV vaccination. Because of the highly effective anamnestic responses, a booster dose was not necessary at least up to 18 years after the primary vaccination.

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Subjects

Close relatives of HBV carriers were recruited into the trial between November 1984 and February 1986. The subjects were between 3 months and 11 years of age. They were screened for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc) by radioimmunoassays (AUSRIA II, AUSAB, and COBAS, respectively; Abbott Laboratories, North Chicago, IL). Inclusion criteria were as follows: (1) serum negative for HBsAg,

Demographics

A total of 318 subjects were randomized into the 3 groups. The number, sex, and mean age of these subjects in each group at study entry are listed in Table 1. Eleven subjects (6 in group 1, 2 in group 2, and 3 in group 3) had an anti-HBs titer <10 mIU/mL at 8 months and were given a booster dose at 12–17 months. These subjects were excluded from the subsequent analyses. There were no differences among the 3 groups in the percentages of patients who did not have anti-HBs titers >10 mIU/mL at 8

Discussion

According to our previous report with 12 years of follow-up, there are no differences in the long-term immunogenicity (as measured by the GMT and the proportion of subjects with an anti-HBs titer ≥10 mIU/mL) and efficacy of HBV vaccination between the 3-dose regimens of recombinant vaccine (group 2) and plasma-derived vaccine (group 3).7 Although the long-term immunogenicity for subjects receiving 2 doses of recombinant vaccine (group 1) was lower when compared with those in groups 2 and 3,

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    Copyright © 2004 American Gastroenterological Association. Published by Elsevier Ltd. All rights reserved.