18-year follow-up study of a prospective randomized trial of hepatitis B vaccinations without booster doses in children.
OBJECTIVE
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 > or =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.
Department of Medicine, Queen Mary Hospital, University of Hong Kong, China.
Man-Fung
MF
Yuen
Wei-Ling
WL
Lim
Annie On-On
AO
Chan
Danny Ka-Ho
DK
Wong
Simon Siu-Man
SS
Sum
Ching-Lung
CL
Lai
D002648:Child; D002675:Child, Preschool; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood*; D006512:Hepatitis B Core Antigens / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage*; D006801:Humans; D007223:Infant; D008297:Male; D011446:Prospective Studies
D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines