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Background: While mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains a significant challenge in China, research investigating the effectiveness of the September 2017 pilot program to eliminate MTCT of HIV, syphilis, and HBV is limited. Baoan district, which has a higher-than-average rate of hepatitis B infection among pregnant women and strong support from the government, was one of six national pilot districts selected for the program. Therefore, this study aims to assess the progress and implementation of the elimination of MTCT of HBV in Baoan district over a period of 5 years., Methods: Data was collected from the national information system for the prevention of MTCT, registration forms, and follow-up forms of pregnant women and their live births from 2018 to 2022. Joinpoint models were used to analyze changing trends over time, calculating annual percentage change (APC) and the corresponding 95% confidence interval (95%CI). Multivariate logistic regression models were used to analyze risk factors for HBV MTCT., Results: From 2018 to 2022, the coverage of HBV screening during pregnancy increased from 98.29 to 99.55% (APC = 0.30, P = 0.012). The coverage of HBV early screening within 13 gestational weeks increased from 40.76 to 86.42% (APC = 18.88, P = 0.033). The prevalence of maternal HBV infection declined by an APC of - 3.50 (95% CI -6.28 ~ - 0.63). The coverage of antiviral therapy among high-risk pregnant women increased from 63.59 to 90.04% (APC = 11.90, P = 0.031). Coverage for timely administration of hepatitis B immunoglobulin, hepatitis B birth dose vaccine, and three-dose hepatitis B vaccination remained consistently above 97.50%. The coverage of post-vaccination serological testing (PVST) in high-risk infants was 56.15% (1352/2408), and the MTCT rate of HBV was 0.18%. Mothers with high-school education or below (OR = 3.76, 95% CI 1.04 ~ 13.60, P = 0.04) and hepatitis B e antigen (HBeAg) positivity (OR = 18.89, 95% CI 1.98 ~ 18.50, P = 0.01) had increased MTCT risk., Conclusions: The implementation of comprehensive prevention strategies in Baoan district, including screening, treatment, and immunoprophylaxis, has proven effective in maintaining the MTCT of HBV at an extremely low level. However, it remains crucial to raise public awareness, specifically on the importance of improving the coverage of PVST for infants exposed to HBV., (© 2023. The Author(s).)

Background: In 2016, the first global viral hepatitis elimination targets were endorsed. An estimated one-third of the world's population of individuals with chronic hepatitis B virus (HBV) infection live in China and liver cancer is the sixth leading cause of mortality, but coverage of first-line antiviral treatment was low. In 2015, China was one of the first countries to initiate a consultative process for a renewed approach to viral hepatitis. We present the investment case for the scale-up of a comprehensive package of HBV interventions., Methods: A dynamic simulation model of HBV was developed and used to simulate the Chinese HBV epidemic. We evaluated the impact, costs, and return on investment of a comprehensive package of prevention and treatment interventions from a societal perspective, incorporating costs of management of end-stage liver disease and lost productivity costs., Results: Despite the successes of historical vaccination scale-up since 1992, there will be a projected 60 million people still living with HBV in 2030 and 10 million HBV-related deaths, including 5.7 million HBV-related cancer deaths between 2015 and 2030. This could be reduced by 2.1 million by highly active case-finding and optimal antiviral treatment regimens. The package of interventions is likely to have a positive return on investment to society of US$1.57 per US dollar invested., Conclusions: Increases in HBV-related deaths for the next few decades pose a major public health threat in China. Active case-finding and access to optimal antiviral treatment are required to mitigate this risk. This investment case approach provides a real-world example of how applied modeling can support national dialog and inform policy planning., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.)

Background: This study aims at evaluating the benefits and harms of hepatitis B immune globulin (HBIG) and hepatitis B vaccine (HBVac) in preventing mother to child transmission in HBV surface antigen (HBsAg) positive pregnant women during antenatal period., Methods: Seven electronic databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), WanFang Database, Chinese Biomedical Literature Database (CBM), VIP Database for Chinese Technical Periodicals (VIP), and 3 clinical trial registry platforms were searched from inception date to December 2017. Only randomized controlled trials (RCTs) were included in this study. The Cochrane risk of bias tool was applied to assessing the risk of bias. The outcomes were analyzed by Review Manager 5.3 software., Results: Sixteen RCTs involving 2440 HBsAg positive pregnant women were included in the meta-analysis. Compared with placebo group, HBIG and HBVac group had a significant decrease in the number of newborns who were HBsAg positive (relative risks [RR]: 0.2, 95% confidence interval [CI] [0.18, 0.40], P < .00001) and HBV-DNA positive (RR: 0.25, 95% CI [0.09, 0.71], P = .010), and had a significant increase in the number of anti-HBs positive newborns (RR: 3.95, 95% CI [3.11, 5.00], P < .00001). After 1-year follow up, the number of HBsAg positive newborns continued to decline (RR: 0.09, 95% CI [0.04, 0.20], P < .00001) and the number of anti-HBs positive newborns continued to increase in HBIG and HBVac group (RR: 1.30, 95% CI [1.22, 1.38], P < .00001). Compared with HBIG group, HBIG and HBVac group had no significant difference in the number of HBsAg positive newborns (RR: 1.68, 95% CI [0.66, 4.30], P = .28), and had a significant decrease in the number of HBsAg positive newborns (RR: 0.31, 95% CI [0.12, 0.84], P = .02). Additionally, only 1 study reported 2 swelling cases, 4 studies were reported no adverse events, and 11 studies were not report adverse reaction., Conclusions: HBIG and HBVac could be an effective alternative for HBsAg positive pregnant women to prevent mother to child transmission. However, due to the limitations of the study, the long-term efficacy and safety of HBIG and HBVac still need long-term and high-quality research to confirm.

Objective: The prevalence of inflammatory bowel disease (IBD) has been increasing worldwide, and the risk of infection has increased due to the use of immunosuppressive and biologic medications. Some of these infections can be prevented with vaccinations. The aim of this study was to evaluate the vaccination practices of Chinese gastroenterologists for patients with IBD., Methods: Questionnaires based on quick response codes were sent using email and the WeChat platform to gastroenterologists at 20 hospitals in China. The vaccination practices of the gastroenterologists, including vaccinating for hepatitis B, hepatitis A, and varicella, were assessed., Results: Of the 468 gastroenterologists who received the questionnaire, 307 (65.6%) completed it. Of the gastroenterologists who were most concerned about hepatitis B; 83.4% always or frequently asked about an infection history, 53.7% took an immunization history, and 73.6% tested patients for hepatitis B infection. However, few gastroenterologists did so for hepatitis A or varicella. The proportion of patients who were asked about an infection and immunization history and tested for varicella infection was 16.0%, 15.0%, and 9.4%, respectively. Only a few gastroenterologists recommended vaccination for patients without an infection before IBD medical treatment (26.7% for hepatitis A, 45.6% for hepatitis B, and 28% for varicella vaccination)., Conclusion: Vaccination practices for patients with IBD used by Chinese gastroenterologists vary greatly, suggesting that education about immunization is needed., (© 2019 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.)

There have been 6-10 million reported patients with chronic hepatitis B virus (HBV) infection worldwide, and the United Nations (UN) called for a "90 % reduction by 2030" strategy. Since the wide practice of HBV vaccination, the numbers of HBV cases have been reduced by 85 % and the incidence of hepatocellular carcinoma has also decreased by 50%. As formulated by the UN in 2015, the sustainable development agenda for the eradication of hepatitis B included the success rate of preventing mother-to-child viral transmission by 95 % , together with the reduction of new hepatitis B infections by 90 % in 2030. In order to achieve the agenda, we proposed a strategy to achieve the "three 96 % " goals derived from the Shanghai experience. In brief, hepatitis B vaccine should cover for 96 % newborns within 24 h, and the vaccination boosting rate should reach 96 % for both one and six months after birth. If cutting off the mother-to-child viral transmission strategy can be successfully achieved, the future of hepatitis B prevention will be promising, and the task of eliminating hepatitis B and controlling hepatocellular carcinoma can be completed ahead of 2030, time proposed by the UN.

Background: To evaluate the impact of the routine hepatitis B vaccination program of infants in China., Methods: The incidence of new hepatitis B infection and coverage with three doses of the vaccines by age groups and provinces were derived from the National Network Direct Report System of Infectious Disease during 2004-10. Chi square test and Pearson correlation analysis were used to analyze differences in incidence according to vaccination coverage and the relationship between the coverage with three doses and the incidence in different provinces., Results: The incidence of new infection was 8.96/100 000 among children with complete coverage (0-15 years old), which was significantly lower than that with partial or no coverage. Among 0-9-year-old children in 2010, the incidence of new infection was 6.36/100 000, which was significantly lower than 2004. Considering the impact of vaccination on cumulative incidence among 0-5-year-old children, a 2.2-fold greater incidence of new infection was observed in provinces with the lowest to the highest vaccination rate., Conclusion: The impact of the routine hepatitis B vaccination program of infants in China has become more apparent over time. Program implementation and regional disequilibrium should be payed attention to as well as the expanded program., (© The Author(s) 2018. Published by Oxford University Press on behalf of Faculty of Public Health.)

In 2016, the World Health Assembly endorsed the Global Health Sector Strategy on viral hepatitis, with aim to eliminate viral hepatitis as a public health threat by 2030, which may reduce the number of new cases of chronic hepatitis B by 90% (0.1% HBsAg prevalence among children) and mortality rate by 65%. In order to achieve this goal, blocking mother-to-child transmission of hepatitis B virus (HBV) is of paramount importance, especially in underdeveloped areas with high prevalence of HBV. In this paper, we discussed the status of chronic HBV infection and its serological and virological characteristics in women of childbearing age in China as well as the optimal dose of immunoglobulin in the combined passive-active immunoprophylaxis in infants born to HBsAg-positive mothers. In addition, the strategies for preventing mother-to-child transmission of HBV in terms of post-immunization testing, increased-dose vaccination (certainty/uncertainty) and follow-up of these infants.

Background & Aims: After nearly 30 years of immunization, there is little known about the prevalence of hepatitis B core antibody (anti-HBc) in Chinese children. The clinical significance of anti-HBc would be more and more important. In this study, we had tried to analyse the prevalence of anti-HBc in vaccinated Chinese children, exploring the post-immunization status based on a large sample sized investigation., Methods: Proportions of anti-HBc were analysed among 215,627 hospitalized Chinese children immunized with HBV vaccination in this study., Results: The proportions of anti-HBc were divided into 3 stages: 36.6% in 0-year-old group, followed by 1- to 10-year-old which stayed relatively stable (5.69 ± 0.40%, [4.86-6.28%]), and significant increasing within 11- to 16-year-old (7.80 ± 1.24%, [6.62-9.74%]), meanwhile, similar changes of HBsAg were showed in the corresponding ages, and significantly increased in children older than 9-year (1.40%, [1.00-2.04%]), comparing with 0.30% in 0-year-old, 0.55 ± 0.13% (0.30-0.64%) in 1- to 9-year-old. The average level of anti-HBc maintains 5.99% in children aged 1- to 16-year with 0.63% for HBsAg., Conclusion: This is the first study of the prevalence of anti-HBc in vaccinated Chinese children: 36.6% of anti-HBc-positivity was found in 0-year-old group, which could be maternal in origin. Relatively high prevalence of anti-HBc may not be ignored in children aged 1- to 16-year-old. Strangely, our data also showed that HBV breakthrough infection would occur in immunized Chinese children older than 9-year-old, and more attention is needed on those children., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

This study aimed to investigate the coverage of hepatitis B vaccine (Hep B) and its completeness and timeliness for birth cohorts from 1999 to 2017 in Zhejiang province, East China. Demographic characteristics and vaccination records of Hep B of children born from 1 January 1999 to 31 June 2017 were extracted from the Zhejiang provincial immunization information system. The timeliness of the first dose of Hep B (Hep B1) was defined as the proportion of children who received the Hep B1 within 24 h after birth among the target population. The completeness of Hep B was defined as the proportion of children who completed the three-dose series of Hep B before 7 years of age. The demographic characteristics of the target population were described. The coverage of each dose of Hep B, the timeliness of Hep B1, and the completeness of Hep B for each birth cohort were described. A logistic regression model was applied to detect the determinants of the timeliness of Hep B1 and the completeness of Hep B vaccination. The coverage of Hep B1 increased from 90.3% to 98.3%, the coverage of Hep B2 increased from 88.8% to 96.1%, and the coverage of Hep B3 increased from 86.4% to 94.2%. The timeliness of Hep B1 increased from 80.3% to 91.3%. The completeness of Hep B increased from 81.3% to 91.5%. The determinants of timeliness of Hep B1 included children's delivery place, immigration status, maternal education level, and economic development level of resident area. The determinants of completeness of Hep B included children's delivery place, immigration status, maternal education level, economic development level of resident area, maternal occupation, and frequency of vaccination service. Zhejiang province had achieved significant improvements in the timely administration of Hep B1 and the completeness of Hep B. To accelerate progress toward additional reductions in the transmission of hepatitis B virus, further efforts need to be focused on improving the timeliness of Hep B1 vaccination and reducing the drop-outs among disadvantaged children with the risk factors identified in this study.

Objective: This study aimed to investigate HBsAg positive rates and risk factors of HBV infection among the children less than 15 years old in Yunnan province, a remote southwest part of mainland China., Methods: Multi-stage sampling was used to randomly select study subjects from 9,360,000 individuals. Hepatitis B vaccine inoculation rate and HBsAg positive rate were investigated, and then propensity score and generalized linear mixed model (GLMMs) were applied to the case-control study., Results: The average HBsAg positive rate was 1.81%, with 1.2% in urban areas and 2.4% in rural areas. Rate of first-dose-in-time in urban areas was 77.7%, obviously higher than 49.5% in rural areas (χ 2 =2811.71, P<0.01). Similarly, 3-dose completion coverage rate in urban areas was 93.7%, also higher than 79.0% in rural areas (χ 2 =1561.43, P<0.01). Maternal HBeAg positivity and HBsAg positivity were proved to be the main risk factors of children with HBV infection. Moreover, paternal HBeAg positivity, paternal HBsAg positivity, the absence and unknown status of HBV vaccine inoculation were risk factors of children with HBV infection as well., Conclusion: It was very important to improve the HBV vaccine inoculation rates. Delivering babies in hospital and timely inoculation with HBV vaccine were efficient ways to prevent HBV vertical transmission., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)

World Health Organization recommends hepatitis B virus (HBV) immunization at 0, 1, and 6 months. However, studies have suggested that shortening the interval between the first and last HBV immunization can improve completion rates. Less clear is whether accelerated immunization is as immunogenic as standard immunization. Thus, the present study aimed to compare the short-term immunogenicity of yeast-derived hepatitis B vaccine in healthy adults immunized on an accelerated or standard schedule. Between June 2013 and March 2014, individuals from Jinfeng and Longmen, China were randomly assigned to receive the vaccine on an accelerated schedule (at 0, 1, and 2 months; n =201) or a standard schedule (at 0, 1, and 6 months; n =206). Subjects filled out a questionnaire asking about demographic and other health data, and they underwent physical examination. Blood was assayed for HBV surface antigen and HBV surface antibody (HBsAb) at 1-2 months after the three-dose schedule. Multivariate binary logistic regression was used to determine whether the rate of anti-HBs seroconversion differed with immunization schedule. Covariance analysis was used to compare geometric mean HBsAb concentration between the two schedules. The anti-HBs seroconversion rate was 84.6% in the accelerated group and 90.3% in the standard group. After controlling for several potential confounders, the accelerated schedule was associated with significantly lower anti-HBs seroconversion rate (OR: 0.560, 95% CI: 0.318-0.988). Similarly, the accelerated schedule was associated with significantly lower geometric mean HBsAb concentration. These results suggest that the standard schedule is more likely to lead to anti-HBs seroconversion and higher HBsAb levels in adults., (© 2018 The Author(s).)

Objective: To determine the prevalence of hepatitis B surface antigens (HBsAg) and hepatitis B surface antibodies (anti-HBs) in 1-12 years-old children in Mianyang city,Sichuan Province., Methods: Children born after the implementation of Hepatitis B immunization policy were selected using a stratified random cluster sampling strategy from January to December 2015. A total of 72 623 eligible children participated in the study,which included a questionnaire survey and blood tests (0.3 mL vein blood) for HBsAg and anti-HBs with ELISA method. Repeated tests were performed on the blood samples with a HBsAg positive result., Results: About 0.24% of the children were HBsAg positive; 64.50% were anti-HBs positive; 35.26% were both HBsAg and anti-HBs negative. The standardized rates based on the 2010 population census were: 0.24% HBsAg positive,64.05% anti-HBs positive,and 35.71% both HBsAg and anti-HBs negative. HBsAg positive rates increased with age, ranging from 0% to 0.65% ( P <0.001). Rural children had a higher HBsAg positive rate (0.32%) than their urban counterparts (0.16%, P <0.001). Those with a family history of Hepatitis B had a higher HBsAg positive rate (1.53%) than those without a family history (0.22%, P <0.001). Anti-HBs positive rates decreased withage,ranging from 47.85% to 71.43% ( P <0.001). Rural children had a lower anti-HBs positive rate (62.06%)than their urban counterparts (66.81%, P <0.001). The prevalence of both HBsAg and anti-HBs negative cases increased with age,ranging from 28.57% to 51.98% ( P <0.001). Rural children had a higher rate of both HBsAg and anti-HBs negative (37.62%) than their urban counterparts (33.03%, P <0.001). About 35.37% of the children who had negative HBsAg and anti-HBs had not received Hepatitis B immunization., Conclusion: Hepatitis B vaccinations are highly effective in Mianyang. However,there are disparities in anti-HBs positive rates between the children with different characteristics. A certain proportion of children are still susceptible to hepatitis B infection. It is necessary to attach importance to neonatal hepatitis B vaccination,surveillance on anti-HBs,and strengthened immunization for the children who are lack of antibody protection., (Copyright© by Editorial Board of Journal of Sichuan University (Medical Science Edition).)

Chronic hepatitis B virus (HBV) infection is an enormous economic and social burden. Asian countries such as Vietnam, Mongolia, Laos, China, the Philippines, South Korea, Singapore and Cambodia have high or high-intermediate HBsAg prevalence. Most of the chronic HBV carriers in this region acquire their infection during early childhood or through mother-to-child transmission (MTCT). Asia has been highly successful in controlling HBV in the last 2 decades. For example, China has adopted a comprehensive strategy to control HBV and has offered universal HBV vaccination to infants since 1992. With increasing coverage and a timely birth dose of the HBV vaccine, the prevalence of HBsAg in that general population decreased from 9.75% in 1992 to 7.18% in 2006. The prevalence of HBsAg in the population <30 years old decreased from 10.1% in 1992 to 2.6% in 2014. In addition, passive and active immunization has been increased and has successfully interrupted MTCT in recent years. Recent studies in China show that maternal antiviral therapy in the late trimesters of pregnancy could further reduce MTCT in mothers with a high viral load. First-line treatments such as entecavir and tenofovir as well as pegylated interferon alpha are recommended in Chinese guidelines and are on the Basic Medical Insurance reimbursement list. Increased awareness, access to and affordability of antiviral therapy will reduce HBV-related morbidity and mortality. The combined efforts of the government, the medical community, industry, civil society and the public should eliminate hepatitis B as a public threat by 2030., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objective: To construct the Markov models to reflect the reality of prevention and treatment interventions against hepatitis B virus (HBV) infection, simulate the natural history of HBV infection in different age groups and provide evidence for the economics evaluations of hepatitis B vaccination and population-based antiviral treatment in China. Methods: According to the theory and techniques of Markov chain, the Markov models of Chinese HBV epidemic were developed based on the national data and related literature both at home and abroad, including the settings of Markov model states, allowable transitions and initial and transition probabilities. The model construction, operation and verification were conducted by using software TreeAge Pro 2015. Results: Several types of Markov models were constructed to describe the disease progression of HBV infection in neonatal period, perinatal period or adulthood, the progression of chronic hepatitis B after antiviral therapy, hepatitis B prevention and control in adults, chronic hepatitis B antiviral treatment and the natural progression of chronic hepatitis B in general population. The model for the newborn was fundamental which included ten states, i.e . susceptiblity to HBV, HBsAg clearance, immune tolerance, immune clearance, low replication, HBeAg negative CHB, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (HCC) and death. The susceptible state to HBV was excluded in the perinatal period model, and the immune tolerance state was excluded in the adulthood model. The model for general population only included two states, survive and death. Among the 5 types of models, there were 9 initial states assigned with initial probabilities, and 27 states for transition probabilities. The results of model verifications showed that the probability curves were basically consistent with the situation of HBV epidemic in China. Conclusion: The Markov models developed can be used in economics evaluation of hepatitis B vaccination and treatment for the elimination of HBV infection in China though the structures and parameters in the model have uncertainty with dynamic natures.

Hepatitis B immunization programs for newborns, children, and adolescents in China have shown remarkable results. To establish whether there would be any benefit in extending the program to cover older individuals, we examined both the epidemiology of hepatitis B virus (HBV) infection and the coverage of hepatitis B vaccinations among adults born before routine vaccinations were implemented. We then evaluated the impact of hepatitis B vaccination in adults aged 20-59 years. A large-scale cross-sectional epidemiological survey of HBV infection was performed in the province of Jiangsu, south-east China, between September 2009 and March 2010. A total of 86,732 adults aged 20-59 years were included, of which 8,615 (9.9%, 95% CI = 9.7-10.1%) were HBsAg sero-positive. Self-reported vaccination status suggested that the coverage was approximately 23.7% (95% CI = 23.4-24.0%). It was shown that higher HBV vaccination coverage was associated with a lower rate of HBsAg seropositivity among adults. There was a negative correlation between hepatitis B vaccination coverage and HBsAg prevalence (correlation coefficient = -0.805, p = 0.016), which might demonstrate the combined effects of vaccination and pre-vaccination HBsAg screening. In the unvaccinated group, the HBsAg-positive rate had an obvious upward trend with age growing among 20-39 year-olds (Trend χ2 = 22.605, P<0.001), while the vaccinated group showed no such trend (Trend χ2 = 3.462, P = 0.063). Overall, hepatitis B vaccination in adults might reduce the rate of HBsAg positivity. Therefore, routine immunization of adults aged 20-39 years should be seriously considered.

Background and Aim: Current baseline data regarding the prevalence of hepatitis B virus (HBV) infections and the immune status in hyperendemic areas is necessary in evaluating the effectiveness of ongoing HBV prevention and control programs in northwest China. This study aims to determine the prevalence of chronic HBV infections, past exposure rates, and immune response profiles in Wuwei City, northwest China in 2010., Methods: Cross-sectional household survey representative of the Wuwei City population. 28,579 participants were interviewed in the seroepidemiological survey ≥1 year of age. House to house screening was conducted using a standard questionnaire. All serum samples were screened by enzyme-linked immunoassays for the presence of hepatitis B surface antigen, antibodies against HBV surface antigen, and antibodies to the hepatitis B core antigen., Results: Among individuals ≥1 year of age, 7.2% (95%CI: 6.3-8.1%) had chronic HBV infections, 43.9% (CI: 40.4-47.4%) had been exposed to HBV, and 23.49% (CI: 21.6-25.3%) had vaccine-induced immunity. Multi-factor weighted logistic regression analysis showed that having household contact with HBV carriers (OR = 2.6, 95%CI: 2.3-3.0) and beauty treatments in public places (OR = 1.2, 95%CI: 1.1-1.3) were the risk factors of HBV infection in whole population. Having household contact with HBV carriers (OR = 3.8, 95% CI: 2.2-6.5) and lack of hepatitis vaccination (OR = 2.0, 95% CI: 1.4-3.3) were the risk factors for HBV infection in children aged 1-14 years., Conclusions: Hepatitis B infection remains a serious public health problem in northwest China. Having household contact with HBV carriers and beauty treatments in public places represented HBV infection risk factors. Hepatitis B vaccine immunization strategies need further improvement, particularly by targeting the immunization of rural migrant workers.

Vaccination against hepatitis B virus is an effective and routine practice that can prevent infection. However, 5-10% of healthy adults fail to produce protective levels of antibody against the hepatitis B vaccination. It has been reported that host genetic variants might affect the immune response to hepatitis B vaccination. Here, we reported a genome-wide association study in a Chinese Han population consisting of 108 primary high-responders and 77 booster non-responders to hepatitis B vaccination using the Illumina HumanOmniExpress Beadchip. We identified 21 SNPs at 6p21.32 were significantly associated with non-response to booster hepatitis B vaccination (P-value <1 × 10(-6)). The most significant SNP in the region was rs477515, located ∼12 kb upstream of the HLA-DRB1 gene. Its P-value (4.81 × 10(-8)) exceeded the Bonferroni-corrected genome-wide significance threshold. Four tagging SNPs (rs477515, rs28366298, rs3763316 and rs13204672) that capture genetic information of these 21 SNPs were validated in three additional Chinese Han populations, consisting of 1336 primary high-responders and 420 primary non-responders. The four SNPs continued to show significant associations with non-response to hepatitis B vaccination (P-combined = 3.98 × 10(-13)- 1.42 × 10(-8)). Further analysis showed that the rs477515 was independently associated with non-response to hepatitis B vaccination with correction for other three SNPs in our GWAS and the known hepatitis B vaccine immunity associated SNP in previous GWAS. Our findings suggest that the rs477515 was an independent marker associated with non-response to hepatitis B vaccination and HLA-DR region might be a critical susceptibility locus of hepatitis B vaccine-induced immunity.

Objectives: The objectives of this retrospective study were to assess the prevalence of HBV and HCV infection in Chinese IBD patients, identify potential risk factors of the infection in this population, and discuss the prevalence of HBV and HCV in the general Chinese population., Methods: A total of 714 IBD patients who had been investigated for HBV and/or HCV infection were consecutively enrolled in the study. Clinical and laboratory data on IBD and hepatitis infection were collected. A control group of 22,373 healthy individuals was also included in the study., Results: Present and past HBV infection was found in 40.62% of IBD patients (ulcerative colitis: HBsAg+, 5.68%; anti-HBc+, 41.64%; Crohn's disease: HBsAg+, 5.29%; anti-HBc+, 39.80%;), and 27.58% of the non-IBD group (HBsAg+, 5.52%; anti-HBc+, 27.58% [P = 0.00]). HCV infection was found in 0.42% of IBD patients and 0.36% of the non-IBD group (P=0.80). One hundred and fifty-four of the IBD patients (21.57%) had been effectively vaccinated for HBV. In a multivariate analysis, age, family history of hepatitis B, and IBD-related admission were significantly related to HBV infection in IBD patients. Potential risk factors for HCV were not analyzed due to the limited number of HCV-positive patients in the study., Conclusions: Prevalence of HBV infection in IBD patients was higher than that in the non-IBD patients, whereas prevalence of HCV infection was similar to that of the non-IBD group. Effective vaccination for HBV was present in only a small proportion of IBD patients., (© 2013.)

Objective: The aim of the study was to estimate long-term cost‑effectiveness of a hepatitis B vaccination catch-up program among children born between 1994 and 2001 (when they were 8‑15 y old) in Shandong province, China, to provide information for nationwide evaluation and future policy making., Methods: We determined the cost-effectiveness of the catch-up program compared with the status quo (no catch-up program). We combined a Decision Tree model and a Markov model to simulate vaccination and clinical progression after hepatitis B virus (HBV) infection. Parameters in the models were from the literature, a field survey, program files, and the National Notifiable Disease Reporting System (NNDRS). The incremental cost‑effectiveness ratio (ICER) was used to compare the 2 alternative strategies. One-way sensitivity analysis, 2-way sensitivity analysis, and probability sensitivity analysis were used to assess parameter uncertainties., Results: The catch-up program was dominant compared with the status quo. Using a total of 5.53 million doses of vaccines, the catch-up program could prevent 21,865 cases of symptomatic acute hepatitis B, 3,088 carrier states with positive hepatitis B surface antigen (HBsAg), and 812 deaths due to HBV infection. The catch-up program could add 28,888 quality-adjusted life years (QALYs) and save $192.01 million in the targeted population in the future. The models were robust, considering parameter uncertainties., Conclusion: The catch-up program in Shandong province among children born between 1994 and 2001 was 'very cost-saving.' It could save life years and reduce total future costs. Our study supported the desirability and impact of such a catch-up program throughout China.

The death of 17 children raised public fears over infant hepatitis B vaccination in China. Though the relation between hepatitis B and children's death was denied after prudent investigation, the negative impact remained. In order to prevent or minimize adverse events after vaccination, special strategy including regulation and reimbursement should be developed.

A nationwide hepatitis B virus (HBV) vaccination program was implemented in China starting in 1992. To study the change in HBV variant prevalence with massive immunization, large HBV surface protein (LHBs) genes from HBV surface antigen (HBsAg)-positive sera were amplified and sequenced. The prevalences of LHBs mutants were compared between the 1992 and 2005 surveys in child and adult groups. The prevalence of "α" determinant mutants in the children increased from 6.5% in 1992 to 14.8% in 2005, where the G145R mutant occurred most frequently. In contrast, mutation frequencies showed little difference between 1992 (9.4%) and 2005 (9.9%) in adults. Moreover, compared to the 1992 survey, the child group surface (S) protein mutation frequency specifically increased (P = 0.005) in the 2005 survey, but the pre-S region mutation frequency did not show a significant difference (P > 0.05). However, the mutation frequency in the adult group increased in both the pre-S and S regions. Furthermore, the frequencies of the disease-related pre-S2 deletion and start codon mutations were significantly higher in the adult groups than in the child groups in both the 1992 and 2005 surveys (P < 0.01). Massive immunization enhances the HBV S protein mutation; the prevalence of LHBs mutants, particularly disease-related mutants, tends to increase with patient age.

Primary liver cancer (PLC) is the third leading cause of cancer mortality globally. In endemic areas of sub-Saharan Africa and Asia, PLC largely arises from chronic infection with hepatitis B virus (HBV) and ingestion of aflatoxins. Although synergistic interactions between these two risk factors have been observed in cohort studies in China, here we determined the impact of agricultural reforms in the 1980s leading to diminished maize consumption and implementation of subsidized universal vaccination against HBV in the 2000s on PLC primary prevention. A population-based cancer registry was used to track PLC mortality in Qidong, China and was compared with the timeline of HBV immunization. Randomly selected serum samples from archived cohort collections from the 1980s to present were analyzed for aflatoxin biomarkers. More than 50% reductions in PLC mortality rates occurred across birth cohorts from the 1960s to the 1980s for Qidongese less than 35 years of age although all were born before universal vaccination of newborns. Median levels of the aflatoxin biomarker decreased from 19.3 pg/mg albumin in 1989 to undetectable (<0.5 pg/mg) by 2009. A population attributable benefit of 65% for reduced PLC mortality was estimated from a government-facilitated switch of dietary staple from maize to rice; 83% of this benefit was in those infected with HBV. Food policy reforms in China resulted in a dramatic decrease in aflatoxin exposure, which, independent of HBV vaccination, reduced liver cancer risk. The extensive HBV vaccine coverage now in place augurs even greater risk reductions in the future.

China has one of the world's highest rates of hepatitis B infection. Over the past 20 years, a series of strategies have been implemented to prevent infection with the hepatitis B virus (HBV) in China. These strategies include hepatitis B (hepB) immunization for susceptible populations such as infants and young children and for high-risk populations such as health care workers and patients, premarital health care for couples of childbearing age, and standard medical practices. A series of measures implemented by the Chinese government caused the HBV infection rate in China to decrease from 9.75% in 1992 to 7.2% in 2006. However, a report on infectious diseases indicated that more than 1 million people in China were infected with hepB in 2011. There is room for improvement. The current work analyzed the current status of and challenges for strategies to prevent HBV infection in China. This work also recommends clear guidance regarding hepB immunization for parents in rural areas, more flexible premarital health care, health education for both patients and health care workers, and routine HBV screening for high-risk health care workers.

Objective: To evaluate the long-term efficacy and duration of yeast-derived recombinant hepatitis B vaccine in hepatitis B virus (HBV)-endemic areas., Method: A cross-sectional investigation was carried out in five HBV-endemic areas. Children who were born between 1997 and 2008 and vaccinated with yeast-derived recombinant hepatitis B vaccine were selected. Serum samples were taken to test HBV infection markers by microparticle enzyme immunoassay, and the results were compared to those before vaccination., Results: 7066 subjects were enrolled. The average adjusted hepatitis B surface antigen (HBsAg) prevalence was 1.02%. HBV core antibody (anti-HBc) prevalence was 3.54%. The overall percentage of HBsAg(-)&Anti-HBc(-)&Anti-HBs(+) was 61.34%. With time after immunization, the percentage annually decreases from 86.11% in 2008 to 49.80% in 1997. Geometric mean concentration (GMC) of anti-HBs decreased significantly annually. The portion of GMC=100-999.9 mIU/ml was 48.0% in 2008, and decreased to 16.7% in 1997., Conclusion: HBsAg prevalence decreased dramatically. This shows that the yeast-derived recombinant hepatitis B vaccine is effective and stable after being used for 12 years in HBV-endemic areas. It is not suggested to carry out booster immunization., (Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.)

Objective: To observe the long-term effect of plasma-derived HBV vaccine., Methods: The effect of a plasma-derived HBV vaccine which was given to children born in 1986 in Huangpu district in Shanghai were followed up once every two years and testing for HBsAg, anti-HBs and anti-HBc was carried out. Compared to background results from cross-sectional survey of hepatitis B virus in 1984 and 1985 (as internal control) as well as finding of survey targeted in non-plasma-derived HBV vaccine of children born in the same time in the nearby area from results investigated in 1991 (as external control), positive rate was calculated to assess the effect of protection., Results: The population immunized was followed up for 23 years and 5993 blood samples were collected. During the period of follow-up, the positive rate of anti-HBs decreased from 89.01% to 18.77% and the average level was 40.39%. The average positive rate of anti-HBc was 1.87%. The annual positive rate fluctuated around the average level. HBsAg positive rate remained less than 1.00% (0.46% - 0.98%), with an average of 0.62% (37/5993). Ranges of positive efficacy were from 81.37% to 95.78% against background control and 72.76% against external control., Conclusion: The plasma-derived HBV vaccine showed a good long-term protective effect and there was no need for boosting the immunization 23 years later.

Background: Among the Chinese population of 1.3 billion, there are an estimated 93 million carriers of hepatitis B virus (HBV). Men who have sex with men (MSM) are at increased risk for HBV infection; however, the prevalence of HBV immunization and infection among Chinese MSM remains undetermined., Methods: A cross-sectional survey of 1,114 eligible participants was conducted in Beijing, China. Multiple methods were used to recruit study participants. Demographic information and potential correlated factors were collected by questionnaire. Additionally, blood specimens were collected and tested for sexually transmitted infections and serologic markers of hepatitis B immunization and infection., Results: Laboratory data were available for 1,111 participants (99.7%), the prevalence of hepatitis B immunization was 38.9%, and 26.5% had serologic markers of HBV infection. Multivariate analyses indicated that higher education level, smaller number of male sex partners in the past 12 months, reported diagnosis of sexually transmitted disease (STD), and history of blood donation were independently associated with HBV immunization. Absence of steady male sex partner(s) in the past 12 months, and reported diagnosis of STD were shown to be independently associated with HBV infection. MSM positive for HBV infection were more likely to have past or current syphilis infection., Conclusions: Low prevalence of HBV immunization and high prevalence of HBV infection among Chinese MSM and a correlation between sexual risk factors and hepatitis B infection indicate that comprehensive preventative measures for HBV among MSM, including blood donor and HIV-STD clinic vaccination programs as well as targeted health education campaigns should be developed in China.

A high rate of chronic HBV infection in China is mainly the result of perinatal or early childhood transmission. Therefore, universal vaccination against HBV in infants has been very successful in the control of chronic HBV infection, with the prevalence of hepatitis B surface antigen decreasing from nearly 10% to approximately 7% in the general population. Adoption of Good Clinical Practice and proper conduction of well-designed clinical trials on conventional and pegylated interferons and nucleos(t)ide analogs have generated important clinical data. The publication and promotion of the evidence-based national guidelines have greatly improved the standard of clinical practice on the prevention and treatment of chronic hepatitis B. The ongoing national key scientific projects on the optimization of vaccination strategy and current anti-HBV therapy will yield important clinical evidence. Inclusion of conventional and pegylated interferons and nucleos(t)ides into the new national reimbursement list will increase the availability and affordability of anti-HBV therapies, thereby further decreasing the morbidity and mortality associated with chronic HBV infection.

Objective: To identify the risk factors of HBV infection in children under the age of 15 in Shanghai and to further enhance the effectiveness of hepatitis B vaccines among children., Methods: Using the data from Shanghai under the national hepatitis B serum epidemiological survey in 2006, 599 children aged 1 - 15 years old were selected as subjects, the subjects were divided into study group and control group by their status on HBV infection. Univariate analysis and multivariate logistic regression analysis were used to identify the risk factors of HBV infection among children., Results: Out of 599 children, 15 of them were infected by HBV with the infection rate as 2.50%. Data from both univariate and multivariate analysis showed that the HBsAg status of their mothers during pregnancy, the history of hepatitis B vaccination and place of birth appeared to be risk factors of hepatitis B infection (P < 0.05), with the OR value of 5.338 for HBsAg-positive mother, 42.118 for no history of hepatitis B vaccination and 12.239 for home-delivery, respectively., Conclusion: In order to further decrease the rate of HBV infection among children in Shanghai, intervention should be focusing on both migrant and HBsAg-positive pregnant women. Also, the condition of hepatitis B vaccine immunization for newborns in some township hospitals should be improved.

Background: Endemic hepatitis B virus (HBV) infection is a serious health problem in China. Hepatitis B vaccination of infants was introduced in 1992 and was progressively expanded during the subsequent 15 years., Methods: We conducted a national serosurvey, with participants selected by multiple-stage random sampling. Demographic characteristics and hepatitis B vaccination history were collected by a questionnaire and a review of vaccination records, and serum specimens were tested for hepatitis B surface antigen, antibody to hepatitis B core antigen, and hepatitis B surface antibody by enzyme-linked immunosorbent assay., Results: Hepatitis B vaccine coverage (3 doses) increased from 30.0% for children born in 1992 to 93.4% for children born in 2005. Receipt of a timely birth dose increased from 22.2% to 82.6% for children born during this interval. Multivariate analysis showed that older age, western and rural residence, birth at home, and certain ethnicities were risk factors for under vaccination with both full vaccine series and timely birth dose. The prevalence of hepatitis B surface antigen was reduced to 2.1% among all children and 1.0% among children born after 1999. The efficacy of hepatitis B vaccination with a timely birth dose was 88.3%., Conclusions: Hepatitis B vaccine has been successfully integrated into routine infant immunization in China, now reaching most infants within 24 h after birth, and the prevalence of hepatitis B surface antigen has been greatly reduced among children born after 1992.

Background: Chinese immigrants in Canada have a disproportionately high risk for hepatitis B compared with non-Hispanic Whites. Hepatitis B is the leading cause of hepatocellular carcinoma among Asian immigrants to North America. English-as-a-second-language (ESL) classes are an effective way of reaching newly immigrated individuals and are a potential channel for delivering health messages., Methods: Using data from 6 focus groups among ESL instructors and students, we characterized perceptions about activities that are successfully used in ESL classrooms and strategies for delivering hepatitis B information. RESULTS. Instructors and students generally reported that activities that focused on speaking and listening skills and that addressed content relevant to students' daily lives were successful in the classroom. Instructors generally avoided material that was irrelevant or too difficult to understand. Focus group participants offered strategies for delivering hepatitis B information in ESL classrooms; these strategies included addressing symptoms and prevention and not singling out a specific population subgroup to avoid stigmatization., Conclusions: These findings might assist efforts to develop ESL curricula that target immigrant populations.

Objective: To study the epidemic pattern and trend of HBV infection in the area where the people had been immunized by HBV vaccine for 20 years., Methods: The whole sampling method was applied in combination with cross-sectional investigation. Blood samples were taken from every member of families. Markers of HBV infection were determined by using solid-phase radioimmunoassay (SPRIA)., Results: (1) The average HBsAg positive rate was 7.5%. The positive rate of markers for HBV infection of 0-19 years old subjects were lower than those of > or = 20 years old subjects. (2) The positive rate of HBsAg of 0-19 years old subjects in 1985 was higher than that in 2005. The anti-HBs positive rate in 1985 stemmed to be higher with age. It was 12.4% in 1- age group to 53.8% in >60 years age group. While the result of 2005 showed that the anti-HBs positive rate of 0-19 years old subjects dropped with age. The anti-HBc positive rate in 1985 also tended to be higher with age. But the result of 2005 showed that the rate of 0-19 years old subjects was just 1.4% to 16.8%., Conclusion: The epidemic patterns of HBV infection have had significant variations in the target population. HBV vaccine immunization has obtained excellent efficacy.

Objective: To prevent perinatal transmission of hepatitis B virus (HBV), WHO recommends that the first dose of hepatitis B (HepB) vaccine be given within 24 hours after birth. This presents a challenge in remote areas with limited cold-chain infrastructure and where many children are born at home., Methods: Rural townships in three counties in China's Hunan Province were randomized into three groups with different strategies for delivery of the first dose of HepB vaccine. In group 1, vaccine was stored within the cold chain and administered in township hospitals. In group 2, vaccine was stored out of the cold chain in villages and administered by village-based health workers to infants at home. Group 3 used the same strategy as group 2, but vaccine was packaged in a prefilled injection device. Training of immunization providers and public communication conveying the importance of the birth dose was performed for all groups., Findings: Among children born at home, timely administration (within 24 hours after birth) of the first dose of HepB vaccine increased in all groups after the study: group 1, from 2.4% to 25.2%; group 2, from 2.6% to 51.8%; and group 3, from 0.6% to 66.7%; P < 0.001 in each case. No significant difference in antibody response to vaccine was observed between the groups., Conclusion: Timely administration of the first dose of HepB vaccine was improved by communication and training activities, and by out-of-cold-chain storage of vaccine and administration at the village level, especially among children born at home.

Objective: To explore the serological infection rate of hepatitis B virus (HBV) in general population aged over one year old in Beijing and to provide information for control and prevention of the disease., Methods: A multistage randomized cluster sampling was carried out in general population of Beijing, aged over one year old. Every study subject's hepatitis B immunization history and main risk factors were investigated through questionnaire. Venous blood samples were collected and then tested for five hepatitis B serological antigens and antibodies by means of Abbott Microparticle Enzyme Immunoassy method., Results: The prevalence rates of HBsAg, anti-HBs, anti-HBc and total HBV infection rate were 3.49% (95% CI:2.99-3.99), 37.79% (95% CI: 36.46-39.12), 35.04% (95% CI: 33.72-36.35) and 35.09% (33.78-36.40) respectively. The age standardized rates were 3.02% ,42.47% ,26.86% and 26.90% respectively., Conclusion: Achievement in hepatitis B control and prevention was made in Beijing since the prevalence rate of hepatitis B surface antigen had been below 1% for children aged less than 5 years old. As for the general population, the prevalence rate of hepatitis B surface antigen had reduced to

Although chronic infection with hepatitis B virus (HBV) is one of the major risk factors for liver cancer, the level of knowledge about liver cancer risk factors and HBV transmission, as well as vaccination have not been assessed in this population. We interviewed Hmong youth living in Fresno, California about liver cancer risk factors. General knowledge of HBV was common, but knowledge of specific modes of transmission was low. For example, only 49% knew that HBV was transmitted by sexual intercourse. We also observed very low prevalence of HBV vaccination (12%), although a majority reported knowing that shots can prevent disease (68%). Liver cancer prevention and control methods targeted to Hmong youth are needed.

Objective: To evaluate the long-term protective effects of hepatitis B vaccine after immunizing to the children for 12 years in Beijing., Methods: The multiple stratified cluster sampling was used in this epidemiological survey. The sampling children's blood serum HBsAg, anti-HBs and anti-HBc were checked and measured by the solid phase radioimmunoassay (SPRIA). The serological level of these index and the causes of the children with HBsAg positive were analyzed., Results: There were 2,419 cases 3-12 years-old children immunized with the hepatitis B vaccine in infant period were surveyed and the total HBsAg positive rate was 0.52%. The vaccine protective rate was 88.45% (95% CI: 65.67%-97.89%). The total anti-HBc positive rate was 2.21%, being no statistical significance among the age groups. The average anti-HBs positive rate of 3-6 years-old children immunized with gene recombining vaccine was 38.79% and descending greatly following the age's dropping. The geometric means of anti-HBs serological titer (GMT) was 52.83 mIU/ml, showing no statistical significance among the age groups. The average anti-HBs positive rate of 6-12 years-old children immunized with the blood rooting vaccine was 50.79%. The geometric means of anti-HBs serological titer (GMT) was 61.51 mIU/ml. There were no statistical significances among the age groups. Among the HBsAg positive children, more than 50% of the children's mothers were HBsAg positive also., Conclusions: The protective effects given by immunization were significant after the hepatitis B vaccine vaccination for 12 years in Beijing. The booster immunization was not necessary, because the HBsAg positive rate didn't ascend obviously as the immunization time prolonging. As the anti-HBs positive rate of children who were immunized by the gene recombining vaccine might be descending following the age's dropping greatly, we should strengthen the serological surveillance of hepatitis B. The main cause that the children became the HBsAg carrier should be a vertical transmission.

The aim of the present study was to investigate the effect of a vaccination program for hepatitis B virus (HBV) on the incidence of HBV-associated glomerulonephritis (HBV-GN). In total, 727 renal biopsies were carried out at our hospital from November 1979 through March 2002. Two groups were established. Group A included those biopsied from November 1979 through December 1991 (prior to the HBV vaccination program) and group B from January 1992 through March 2002. Group B was divided into five subgroups (B(1 )to B(5)), with an interval of 2 years between each subgroup. Patients were divided into those with or without a history of HBV vaccination. Of the 727 renal biopsies, 64 fulfilled the criteria of HBV-GN, There were 28 cases of the 211 cases in group A and 36 cases of the 516 cases in group B ( X(2)=7.397, P<0.01). The incidence in group A and group B(1 )through B(5 )was 13.27% (28/211), 13.04% (9/69), 7.32 (6/82), 6.25% (4/64), 4.88% (4/82), and 5.94% (13/219), respectively ( X(2)=9.627, P<0.01). Only 8 of the 231 vaccinated children had HBV-GN, while there were 48 HBV-GN cases of the 381 non-vaccinated children ( X(2)=14.44, P<0.001). There were only 6 cases of membranous nephropathy (MN) in the vaccinated group, while 40 cases of MN occurred in the non-vaccinated group ( X(2)=12.92, P<0.01). There were 8 children that developed HBV-GN with abnormal serum HBV markers despite HBV vaccination. Two mothers of these 8 children had evidence of HBV infection. The incidence of HBV-GN in children has been decreasing each year since the implementation of the nationwide HBV vaccination program in Shanghai, China. Furthermore, since childhood MN is associated with HBV, vaccination can also reduce the incidence of childhood MN.

Background: Before universal infant immunization against hepatitis B virus (HBV) in 1986 China was a region endemic for HBV infection. The prevalence of HBV infection in the population was about 60% and the proportion of chronic HBV carriers around 10%. These HBV carriers could progress to chronic hepatitis B, cirrhosis, and primary hepatocellular carcinoma. Since 1976, large-scale sero-surveys of HBV infection have been carried out and a lot of data have been collected., Method: This paper describes a mathematical model developed to predict the dynamics of HBV transmission and to evaluate the long-term effectiveness of the vaccination programme. We used a compartment model expressed by a set of partial differential equations based on the characteristics of HBV infection., Results: All parameters, expressed in the model as a non-linear function of age and time since vaccination, were estimated using sero-survey data. The model fits well with both pre-vaccination and post-vaccination sero-surveys. The observed and estimated age-specific prevalence rates of HBV infection and HBV carriage agree with each other. According to our model, if all newborns are vaccinated according to schedule, the rate of HBV carriage will decline sharply over time to 0.2% in 70 years. By then, the ratio of acute hepatitis B will be less than 0.5% and the ratio of chronic hepatitis B will be around 5%., Conclusions: The results suggest that HBV infection in China can be controlled in just one generation, and eventually eliminated. Our model shows that vaccination coverage is the most important indicator for the elimination of HBV transmission. The higher the vaccination coverage, the better the long-term effectiveness of immunization. Thus, the key to controlling and eliminating HBV transmission in China is to find ways to immunize all infants throughout the country, especially in poor, rural areas.

Twenty-four infants who became positive to the surface antigen of hepatitis B virus (HBsAg) despite a complete course of active postexposure immunization with plasma derived hepatitis B vaccine were studied. The polymerase chain reaction amplified products of the common neutralizing epitope 'a' determinant of HBsAg (Nucleotide 419-598) from serum samples were sequenced and analyzed for nucleotide mutations. Four cases (16.7%) had mutations that led to amino acid substitutions between codons 124 and 147. Only one case (N1) showed a substitution at codon 145 (from glycine to arginine, 145R), the other three were at codons 126-129. The mother of N1 was co-infected with the wild type and the mutant virus. Five years later, serum of N1 showed only the wild type virus. There was no significant relationship between the mutation rate and the anti-HBs response to hepatitis B vaccination. Results suggest that without immune selective pressure, 145R variant was not frequently observed, and was not stable. Mutation in the 'a' determinant was not an important cause of failure to prevent maternal-infant transmission of HBV by active postexposure hepatitis B immunization in Chinese children.