Background: Maternal exposure to dietary factors during pregnancy may modulate the immunity of offspring by epigenetic programming. But the relationship between intrauterine environment and persistence of protective antibody after hepatitis B vaccination has not been reported. This study was to investigate the 5-year persistence of protective antibody response after primary hepatitis B vaccination, and its relationship with maternal folic acid supplementation. Materials and Methods: A total of 1461 children who completed a 3-dose 10 μg recombinant hepatitis B vaccine at birth and did not infect hepatitis B virus were followed up. Logistic regression and mediation analysis was used to explore the relationship between 5-year persistence of protective antibody and maternal nutrition. Results: Of 1403 children who did not revaccinated during the follow-up, 76.1% had protective hepatitis B surface antibody (anti-HBs) levels. Twenty percent of mothers did not take folate during pregnancy. Mediation analysis showed a total effect of folic acid supplementation on good persistence (odds ratio: 1.10, 95% CI: 1.03-1.17, p = 0.0010), a direct effect was 1.07 (95% CI: 1.01-1.13, p = 0.0128) and an indirect effect was 1.03 (95% CI: 1.00-1.06, p = 0.0672); the proportion of good persistence mediated by primary response was 30.3%. Conclusion: This study indicated a good protective anti-HBs persistence at year 5 after 10 μg recombination hepatitis B vaccination in infants. Maternal folic acid supplementation may improve the persistence of protective antibodies through other pathways. Multi-center cohort studies should be conducted to verify this conclusion.

Background: The widely recommended standard schedule of hepatitis B vaccine for adults is months 0, 1 and 6, which takes 6 months to complete. Rapid completion of one vaccination schedule is important to adults because of its low compliance with follow-up doses. A new type of 60 μg Hepatitis B vaccine, made by Shenzhen Kangtai Biological Products Co., LTD., is originally recommended for low or non-responders. The objective of this clinical trial was to test whether this 60 μg hepatitis B vaccine could be used in primary immune population and what is its level of immunogenicity and safety compared with other hepatitis B vaccines. Methods: This is a 2-center randomized controlled study. A total of 1169 healthy adults aged between 25 and 55 who tested negative for HBsAg, anti-HBs, and anti-HBc were eligible for the study and were enrolled from relatively fixed and stable sites, such as villages, schools and large enterprises et al in Xuanhua county in Hebei province and Huaibei county in Anhui province. They were randomized to group A (20 μg Engerix-B® with 0, 1, 6 month intervals), group B (20 μg Kangtai hepatitis B vaccine with 0, 1, 6 month intervals), group C (60 μg Kangtai hepatitis B vaccine with 0, 2 month intervals) and group D (20 μg Huabei hepatitis B vaccine made by recombinant DNA techniques in CHO cell with 0, 1, 6 month intervals). In group A, B and D, every study object's blood sample was collected in the second month after their final injection to test the anti-HBs levels; while in group C, the blood sample was collected in the second month after the first and the second injection to test the anti-HBs levels. Adverse events were collected after each dose to assess the vaccines' safety. Results: The seroprotection rates were 93.17%, 97.23%, 93.54% and 98.98% respectively and the geometric mean titers (GMTs) were 1033.38 mIU/ml, 600.75 mIU/ml, 265.69 mIU/ml and 1627.05 mIU/ml in group A,B,C and D respectively. The difference of seroprotection rate among the 4 groups was statistically significant (χ² = 17.26, P<0.05). The difference of titers of anti-HBs among the 4 groups was statistically significant (H = 162.42, P<0.05). BMI, age (older than 40) and smoking were the influence factors of anti-HBs levels on 60 μg hepatitis B vaccine. Conclusion: 60 μg hepatitis B vaccine has a satisfactory safety and seroprotection rate in adult, It could be used in rapid adult hepatitis B immunization.

Evidence on the effectiveness of hepatitis B virus (HBV) infection screening and vaccination programs remains rare in China. We used a quasi-experimental method, propensity score matching, to evaluate the effects of a community-based HBV infection detection combined with vaccination (HBVIDV) program in a pilot. Data were retrieved from the HBVIDV program implemented between July 2019 and June 2020. Outcomes were the difference between the treatment and control groups in hepatitis B vaccination (≥1 dose), hepatitis B vaccine series completion (≥3 doses), and serologic evidence of vaccine-mediated immunity. Altogether, 26,180 individuals were included, where 6160 (23.5%) individuals were assigned to the treatment group, and 20,020 (76.5%) individuals were assigned to the control group. After propensity score matching, 5793 individuals were matched. The rates of hepatitis B vaccination, hepatitis B vaccine series completion, and prevalence of vaccine-mediated immunity in the treatment and control groups were 29.0% vs. 17.8%, 22.1% vs. 13.1%, and 38.2% vs. 27.6%, respectively. The HBVIDV program was significantly associated with increased hepatitis B vaccination rate (OR, 1.884, 95% CI 1.725–2.057), hepatitis B vaccine series completion rate (OR, 1.872, 95% CI 1.696–2.065), and prevalence of vaccine-mediated immunity (OR, 1.623, 95% CI 1.501–1.755). The greater magnitude of association between HBVIDV program and outcomes was observed among adults aged 35–54 years and adults who live in rural areas. The HBVIDV program was effective in increasing the hepatitis B vaccination rate, hepatitis B vaccine series completion rate, and prevalence of vaccine-mediated immunity among adults in the pilot. Further focusing the program on special populations and regions may produce more effective results.

The 20 μg (0–1–6 month) hepatitis B virus (HBV) vaccination is widely recommended for HBV vaccine-naïve immune adults in China. However, suboptimal protective responses may occur due to dose-series incompletion. We aim to investigate the immunogenicity of a 60 μg HB vaccine with a 0–2 month series among HBV vaccine-naïve immune adults aged 25–55 to assess potential alternative approaches for HB immunization. A two-center randomized controlled trial was carried out. Participants were randomly allocated to either the 20 μg (0–1–6 month) or the 60 μg (0–2 month) regimen. Blood samples were collected eight weeks after the final injection to measure the antibodies. A total of 583 adults (289 in the 20 μg regimen and 294 in the 60 μg regimen) were included. The seroprotection rates (SPRs) were 97.23% and 93.54% in the 20 μg and 60 μg regimens, respectively (p = 0.0261), and the geometric mean concentrations were 600.76 mIU/mL and 265.68 mIU/mL, respectively (p < 0.0001). The immunogenicity of the 60 μg regimen decreased significantly with age, particularly in adults aged 40 and older. The 60 μg regimen may be beneficial for adults under 40, especially those with poor compliance or in urgent need of immunization.