[Comparison of antibody persistence after two-dose and three-dose hepatitis B vaccines for 20 years among people aged 15-40 years in Shandong Province].

Abstract

Objective: To investigate the antibody persistence and influencing factors of the simplified two-dose and standard three-dose hepatitis B vaccine (HepB) among people aged 15-40 years after 20 years of primary immunization. Methods: In November 2003, a total of 1 994 healthy people aged 15-40 were randomly selected from 20 villages in Jiyang County, Jinan City, Shandong Province. Venous blood samples were collected from 3-5 ml of people who tested negative for hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs), and anti-hepatitis B core antibody (anti-HBc). A total of 850 people were included in the study. The study randomly assigned 428 people to the "0-1-6" immunization program group and 422 people to the "0-6" immunization program group, and administered primary immunization to people using 10 μg HepB according to the corresponding program. 629 people completed full immunization and underwent blood sampling and anti-HBs testing one month after immunization. Blood samples were collected at 1 month, 12 years (2015), and 20 years (2023) after primary immunization, and solid-phase radioimmunoassay (SPRIA) or chemiluminescence particle immunoassay (CMIA) were used to detect anti-HBs, HBsAg, and anti-HBc. Simultaneously, a questionnaire survey was conducted, and information on birth date, gender, vaccination time, HepB immunization history, smoking history, alcohol consumption history, chronic disease history, and family members' hepatitis B infection history were collected during the baseline survey and follow-up survey. The generalized estimation equation (GEE) was used to analyze the main effects, interaction effects, and influencing factors of anti-HBs seropositive rates and geometric mean concentration (GMC). Results: A total of 304 people were followed up at 1 month, 12 years (2015), and 20 years (2023) after primary immunization, with 50.99% (155 people) in the "0-1-6" immunization program group. In 2003, 2015, and 2023, the seropositive rates of anti-HBs in the "0-1-6" immunization program group were 94.19% (95%CI: 89.26%-97.31%), 74.19% (95%CI: 66.56%-80.88%), and 69.68% (95%CI: 61.79%-76.79%), respectively. The seropositive rates of anti-HBs in the "0-6" immunization program group were 87.25% (95%CI: 80.80%-92.14%), 55.03% (95%CI: 46.68%-63.18%), and 51.01% (95%CI: 42.70%-59.28%), respectively. In 2003, 2015, and 2023, the anti-HBs GMC of the "0-1-6" immunization program group were 268 (95%CI: 200-359) mIU/ml, 34 (95%CI: 26-46) mIU/ml, and 37 mIU/ml (95%CI: 27-51), respectively. The anti-HBs GMC of the "0-6" immunization program group were 121 (95%CI: 87-168) mIU/ml, 13 (95%CI: 9-18) mIU/ml, and 15 (95%CI: 11-20) mIU/ml, respectively. The main effects analysis of GEE showed that there were statistically significant differences in the anti-HBs seropositive rates and GMC between the "0-1-6" immunization program group and the "0-6" immunization program group (both P 0.05). The multivariate analysis of GEE showed that compared with the "0-1-6" immunization program group and the 2003 baseline, the "0-6" immunization program group (OR=0.45, 95%CI: 0.30-0.68, P<0.001) had lower anti-HBs seropositive rates in 2015 and 2023 (OR=0.17, 95%CI: 0.12-0.25, P<0.001; OR=0.14, 95%CI: 0.10-0.20, P<0.001). Compared with the "0-1-6" immunization program group, baseline in 2003, and without chronic disease history, people in the "0-6" immunization program group (β=-0.83, 95%CI:-1.19--0.47, P<0.001) had lower anti-HBs GMC in 2015 and 2023 (β=-2.15, 95%CI:-2.37--1.93, P<0.001; β=-2.04, 95%CI:-2.27--1.80, P<0.001), and those with chronic disease history (β=0.55, 95%CI: 0.02-1.08, P=0.043). Conclusion: Compared with those receiving three-dose HepB, people receiving two-dose HepB have lower anti-HBs seropositive rates and GMC. Seropositive rates are associated with immunization program and follow-up duration, while the anti-HBs GMCs are associated with immunization program, follow-up duration, and chronic disease history.