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Background: The prevalence of chronic hepatitis B virus (HBV) poses a significant threat to the lives of 257 million individuals globally, potentially resulting in severe outcomes such as liver cirrhosis or hepatocellular carcinoma. Among the existing preventive measures, yeast-derived vaccines have proven to be the most efficacious approach in combatting hepatitis B. Nonetheless, as scientific inquiries focus more on occult HBV infection (OBI) in vaccinated persons and the lingering risk of vertical transmission affecting 10-30 % of babies born to HBsAg-positive mothers, there is a growing apprehension regarding the inability of HBV vaccines to ensure complete immunity. This study aims to offer a more comprehensive understanding of the implications of widespread HBV vaccination initiatives on OBI while tackling the primary limitations associated with current vaccine formulations. Methods: The exploration was conducted on PubMed, Scopus, and Web of Science databases to pinpoint research on OBI within vaccinated cohorts. A sum of 76 suitable studies was recognized. Discussion: Multiple studies have documented the occurrence of OBI in fully vaccinated individuals, including both the general population and high-risk groups, such as newborns born to HBsAg-positive mothers. Factors contributing to vaccine failures include low-level anti-HBs antibodies, high maternal viral loads in mother-to-child transmission cases, as well as the presence of vaccine escape mutants and heterologous HBV genotypes. However, further research is needed to precisely understand the impact of active immunization on the emergence of OBI in vaccinated populations. Nonetheless, it is apparent that the advancement of more effective HBV vaccines could potentially lead to the extinction of HBV.

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Background: Undergraduate nursing students in clinical practice have a higher risk of hepatitis B infection. The prevalence and factors associated with hepatitis B vaccination (HBV vaccine) uptake among nursing students remained unknown. This study examined the prevalence and factors associated with HBV vaccination among clinical nursing students. Methodology: A sample of 229 undergraduate nursing students was enrolled in an analytical cross-sectional study. Sociodemographic data, status of vaccination, and beliefs about HBV infection and vaccination using domains of the health belief model (HBM) were collected in a face-to-face interview using a questionnaire. Descriptive statistics were used to summarise the participants' characteristics and prevalence of HBV vaccination. Multivariate logistic regression analysis was used to examine the association between sociodemographic factors and domains of the HBM model and HBV vaccination uptake. Results: The prevalence of vaccination uptake was 25.8%. Sociodemographic factors associated with uptake of the HBV vaccine included being female (P =.031), being a final-year student (P =.013), and having knowledge of HBV (P =.049). As for HBM, two domains, perceived benefit [Adjusted Odds Ratio (AOR) = 1.40; 95% CI, 1.05 to 1.86; P=.022] and self-efficacy (AOR = 1.87, 95% CI, 1.12 to 3.11; P=.016), were significantly associated with HBV vaccine uptake. Conclusion: HBV vaccination uptake among undergraduate clinical nursing students was low. Clinical experience, knowledge, perceived benefit, and self-efficacy were positively associated with HBV vaccine uptake. Interventions to improve these domains among BSc Nursing students should be promoted to improve vaccination uptake.

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BACKGROUND AND OBJECTIVES: Hepatitis B virus (HBV) infection is common in people with chronic kidney diseases (CKD). The guidelines recommend four doses, 2.0 mL each, of HBV vaccine, given at zero, one, two and six months in these patients. However, real-life data on the effectiveness of this schedule are limited. We retrospectively reviewed the HBV vaccine response in the CKD population. METHODS: The study included adult (≥ 18 years) patients with glomerular filtration rate < 60 mL/min, if they had received four doses (each of 2.0 mL volume) of HBV vaccine and anti-HBs titer was measured at ≥ 1 month of the last dose of vaccine. Participants with hepatitis C or human immunodeficiency virus (HIV) coinfection, organ transplant recipients, active or remote malignancy or use of immunosuppressive medication were excluded. Anti-HBs antibody was measured with two different assays with their limits of detection up to 500 mIU/mL and 1000 mIU/mL. The presence of detectable anti-HBs antibody and anti-HBs titer ≥ 10 mIU/mL defined seroconversion and seroprotection, respectively. RESULTS: The study included 208 patients (71.9% males; age 44 [33-55] years; CKD stage II/III/IV/V in 1.4%/7.2%/26.4%/64.9%; 46% on maintenance hemodialysis [MHD]). Overall, seroconversion and seroprotection were achieved in 174 (83.7%) and 161 (77.4%) participants and anti-HBs titer, measured three (2-8) months after the fourth dose, was 124 (12-500) mIU/mL. The median anti-HBs antibody levels at ≤ 6, 7-12, 13-24 and 24 months after the fourth doses were 116, 478, 43 and 70 mIU/mL, respectively. Age, body mass index, stage of CKD, serum albumin and dialysis status were not associated with seroprotection (p < 0.05). CONCLUSION: A standard vaccination schedule of four 2.0 mL doses of HBV vaccine in CKD patients induces reasonably good and sustained seroprotection.

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HepB-CpG is a licensed adjuvanted two-dose hepatitis B vaccine for adults, with limited data on exposure during pregnancy. We assessed the risk of pregnancy outcomes among individuals who received HepB-CpG or the 3-dose HepB-alum vaccine ≤28 d prior to conception or during pregnancy at Kaiser Permanente Southern California (KPSC). The pregnancy cohort included KPSC members aged ≥18 y who received ≥1 dose of hepatitis B vaccine (HepB-CpG or HepB-alum) at KPSC outpatient family or internal medicine departments from August 2018 to November 2020. We followed these individuals through electronic health records from the vaccination date until the end of pregnancy, KPSC health plan disenrollment, or death, whichever came first. Among 81 and 125 eligible individuals who received HepB-CpG and HepB-alum, respectively, live births occurred in 84% and 74%, spontaneous abortion occurred in 7% and 17% (adjusted relative risk [aRR] 0.40, 95% CI: 0.16-1.00), and preterm birth occurred in 15% and 14% of liveborn infants (aRR 0.97, 95% CI 0.47-1.99). No major birth defects were identified through 6 months of age. The study found no evidence of adverse pregnancy outcomes for recipients of HepB-CpG in comparison to HepB-alum.

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Hepatitis B (HB) infection is a major global health problem. There is limited knowledge about HB vaccination-induced immune memory responses. We compared the frequency of CD8+ memory T cell subsets between responders (RSs) and non-responders (NRs) to HB vaccination. Blood samples were collected from RSs and NRs. PBMCs were cultured in the presence of Hepatitis B surface antigens (HBsAg) and PHA for 48 h to restimulate CD8+ memory T cells and T cell memory subsets were detected by flow cytometry using memory cell markers. The frequency of TEM, TCM, and TCM hi was significantly higher in responders compared to non-responders (p = 0.024, 0.022, and 0.047, respectively). Additionally, we report a positive correlation between the frequency of TEM cells in RSs with age and anti-HBsAb level (p = 0.03 and rs = 0.5; p = 0.01 and rs = 0.06). Responders display a higher level of CD8+ T cell-mediated immunity. Therefore, we suggest a possible defect in the formation of immunological CD8+ memory T cells in NRs and it may reduce antibody production compared to the RSs, although more experiments are needed.

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BACKGROUND: Nigeria has the largest number of children infected with hepatitis B virus (HBV) globally and has not yet achieved maternal and neonatal tetanus elimination. In Nigeria, maternal tetanus diphtheria (Td) vaccination is part of antenatal care and hepatitis B birth dose (HepB-BD) vaccination for newborns has been offered since 2004. We implemented interventions targeting healthcare workers (HCWs), community volunteers, and pregnant women attending antenatal care with the goal of improving timely (within 24 hours) HepB-BD vaccination among newborns and Td vaccination coverage among pregnant women. METHODS: We selected 80 public health facilities in Adamawa and Enugu states, with half intervention facilities and half control. Interventions included HCW and community volunteer trainings, engagement of pregnant women, and supportive supervision at facilities. Timely HepB-BD coverage and at least two doses of Td (Td2+) coverage were assessed at baseline before project implementation (January-June 2021) and at endline, one year after implementation (January-June 2022). We held focus group discussions at intervention facilities to discuss intervention strengths, challenges, and improvement opportunities. RESULTS: Compared to baseline, endline median vaccination coverage increased for timely HepB-BD from 2.6% to 61.8% and for Td2+ from 20.4% to 26.9% in intervention facilities (p < 0.05). In comparison, at endline in control facilities median vaccination coverage for timely HepB-BD was 7.9% (p < 0.0001) and Td2+ coverage was 22.2% (p = 0.14). Focus group discussions revealed that HCWs felt empowered to administer vaccination due to increased knowledge on hepatitis B and tetanus, pregnant women had increased knowledge that led to improved health seeking behaviors including Td vaccination, and transportation support was needed to reach those in far communities. CONCLUSION: Targeted interventions significantly increased timely HepB-BD and Td vaccination rates in intervention facilities. Continued support of these successful interventions could help Nigeria reach hepatitis B and maternal and neonatal tetanus elimination goals.

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Introduction Hepatitis B virus (HBV) is a highly infectious disease affecting the liver, causing life-threatening acute and chronic hepatitis. It poses a significant global public health burden and is a major occupational risk for healthcare workers (HCWs) due to transmission through blood and blood products. Given their increased risk compared to the general population, vaccination is crucial in limiting the spread of HBV and protecting HCWs. This study aims to measure the anti-HBs titers of HCWs in the Farwaniyah Health District in Kuwait after completing three doses of the HBV vaccine. Methods This cross-sectional study was conducted in the Farwaniyah Health District of Kuwait between May and July 2023. We collected data from 556 participants from various departments, including physicians, nurses, and laboratory technicians, chosen through simple random sampling. Inclusion criteria included the completion of three doses of the HBV vaccine (Engerix-B recombinant vaccine, GlaxoSmithKline Biologicals, Brentford, UK). Demographic data were collected, and blood samples were tested for hepatitis B surface antigen antibody titers using fourth-generation enzyme-linked immunosorbent assay. Participants were categorized based on sex, age, specialty, and time since the last vaccine dose. The chi-square test and Fisher's exact test assessed differences in categorical variables, with a p-value of <0.05 considered statistically significant. Results The study included 556 participants, with 304 (54.7%) women and 252 (45.3%) men. Participants were assigned into two age groups: 294 (52.9%) were 18 to 40 years old and the remainder (262) were over 40. Most participants were nursing staff (n=392; 70.5%), followed by physicians (n=110; 19.7%) and technicians (n=54; 9.7%). A high proportion (n=340; 61.2%) received their last vaccine dose within the last five years. Overall, 375 (67.4%) HCWs developed sufficient anti-HBs titers of ≥100 mIU/mL while 181 (32.6%) had levels below 100 mIU/mL. Age between 18 and 40 years and receiving the vaccine within the last five years were significantly associated with protective titer levels, while sex was not. Nurses had significantly higher immunity levels compared to doctors and technicians. Conclusions HCWs in the Farwaniyah area of Kuwait generally responded positively to the HBV vaccine. Younger HCWs and those who received the vaccine more recently were more likely to have a protective immune response. Nurses demonstrated higher rates of seroconversion compared to doctors and technicians. These results suggest that HBV vaccination programs should prioritize timely booster doses, especially for older HCWs and those vaccinated long ago. Monitoring antibody levels is crucial to ensure ongoing protection, particularly in high-risk groups such as nurses. Implementing these measures can enhance the effectiveness of HBV vaccination programs, reduce HBV incidence among HCWs, and contribute to a safer healthcare environment. Post-vaccination testing is essential to ensure the safety of all HCWs against HBV.

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The investigation was conducted to describe the status of coverage of HBV vaccination among the health care workers in Gansu province and to explore the associated factors of HBV vaccination in this study. A cross-sectional study was conducted among 1544 health care workers from 64 hospitals in Gansu province. A self-designed questionnaire was used to interview the health care workers about HBV vaccination coverage. A multivariate logistic regression model explored the associated factors with HBV vaccination. The vaccination coverage was 89.17% for health care workers, nurses (90.40%) had the highest rate, followed by administration staff (89.38%) and medical technicians (89.30%). The full-dose HBV vaccination coverage was 64.25% for health care workers, and administration staff (65.04%) had the highest rate, followed by nurses (65.00%). This study found that the associated factors with HBV vaccination and full-dose vaccination were the history of training and the detection of serological indicators. The coverage of HBV vaccination among health care workers in Gansu province was high, but full-dose HBV vaccination coverage was low. It is necessary to strengthen the HBV knowledge and training in HBV prevention and treatment among health care workers in Gansu Province.

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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.

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Hepatitis B virus (HBV) infection remains a significant global health concern worldwide, contributing to high rates of mortality and morbidity, including chronic hepatitis B, cirrhosis, and hepatocellular carcinoma (HCC). Universal vaccination programs have significantly reduced the rate of HBV transmission; however, a subset of individuals fail to develop a protective immune response following vaccination and are termed nonresponders. A comprehensive search strategy using the PubMed, Google Scholar, and Web of Science databases was employed to search for relevant studies using keywords including "hepatitis B vaccine", "vaccine nonresponse", "immunogenicity", "immune response to the hepatitis B vaccine", and "associated risk factors". Factors influencing the vaccine's response include demographic factors, such as age and sex, with increased nonresponse rates being observed in older adults and males. Obesity, smoking, and alcohol consumption are lifestyle factors that decrease the vaccine response. Medical conditions, including diabetes, chronic kidney and liver diseases, HIV, celiac disease, and inflammatory bowel disease, affect the vaccine response. Major histocompatibility complex (MHC) haplotypes and genetic polymorphisms linked to immune regulation are genetic factors that further influence the vaccine's effectiveness. To reduce the global burden of hepatitis B infection, it is essential to understand these factors to improve vaccine effectiveness and develop individualized vaccination strategies.

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BACKGROUND: The advent of the hepatitis B vaccine has achieved tremendous success in eradicating and reducing the burden of hepatitis B infection, which is the main culprit for hepatocellular carcinoma-one of the most fatal malignancies globally. Response to the vaccine is achieved in about 90-95% of healthy individuals and up to only 50% in immunocompromised patients. This review aimed to provide an overview of hepatitis B vaccine non-response, the mechanisms involved, B cell amnesia, and strategies to overcome it. METHODS: Databases, including Google Scholar, PubMed, Scopus, Cochrane, and ClinicalTrials.org, were used to search and retrieve articles using keywords on hepatitis B vaccine non-response and B cell amnesia. The PRISMA guideline was followed in identifying studies, screening, selection, and reporting of findings. RESULTS: A total of 133 studies on hepatitis B vaccine non-response, mechanisms, and prevention/management strategies were included in the review after screening and final selection. Factors responsible for hepatitis B vaccine non-response were found to include genetic, immunological factors, and B cell amnesia in healthy individuals. The genetic factors were sex, HLA haplotypes, and genetic polymorphisms in immune response markers (cytokines). Non-response was common in conditions of immunodeficiency, such as renal failure, haemodialysis, celiac disease, inflammatory bowel disease, hepatitis C co-infection, and latent hepatitis B infection. Others included diabetes mellitus and HIV infection. The mechanisms involved were impaired immune response by suppression of response (T helper cells) or induced suppression of response (through regulatory B and T cells). DISCUSSION: A comprehensive and careful understanding of the patient factors and the nature of the vaccine contributes to developing effective preventive measures. These include revaccination or booster dose, vaccine administration through the intradermal route, and the use of adjuvants in the vaccine.

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This prospective study enrolled healthcare workers (HCWs) who were nonresponders following at least 5 doses of aluminum-adjuvanted hepatitis B vaccine who received the 2-dose Heplisav-B (HepB-CpG) (Dynavax Technologies Corporation, Emeryville, CA) series. After 2 doses of HepB-CpG, 43/47 (91%) participants, and with 1 dose, 41/49 (84%) responded. HepB-CpG could be the preferred vaccine in HCW nonresponders. Clinical Trials Registration. Clinicaltrials.gov NCT04456504.

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BACKGROUND: The disproportionate burden of viral hepatitis, particularly hepatitis B virus (HBV) is experienced by people living in low-resourced sub-Saharan Africa, where the estimated prevalence is 3-7 times the global average. Therefore to inform policy, we describe the seroprevalence and trends of hepatitis C (HCV) and HBV biomarkers: anti-HCV antibody and hepatitis B surface antigen (HBsAg), respectively, in Zimbabwe. METHODS: We analysed data from 181,248 consecutive blood-donors, examined between January 2015 through December 2018. Additionally, we conducted a comprehensive literature review using PubMed and African Journals Online databases, meta-analysing selected papers from Zimbabwe, published between 1970 and 2020, that met specific criteria. RESULTS: Overall age-standardized prevalence rate (ASPR) for anti-HCV was 8.67 (95%CI, 0.25-17.09) per 100,000, while that for HBsAg was 2.26 (95%, 1.89-2.63) per 1000 blood-donors, per year. Meta-analysis of 9 studies comprising 220,127 persons tested for anti-HCV revealed ASPR of 0.05% (95% 0%-0.19%) in blood-donors and 1.78% (95%CI, 0.01%-5.55%) in the general population, for an overall pooled ASPR of 0.44 (95%CI, 0.19%-0.76%). 21 studies comprising 291,784 persons tested for HBsAg revealed ASPR of 0.65% (95%CI, 0.31%-1.00%) in blood-donors and 4.31% (95%CI, 1.77%-6.50%) in the general population for an overall pooled ASPR of 4.02% (95%CI, 3.55%-4.48%), after HBV vaccine introduction. HBsAg prevalence was significantly higher before HBV vaccine introductions. CONCLUSIONS: The prevalence of HBV is decreasing, consistent with the introduction of HBV vaccination, while HCV prevalence is increasing in Zimbabwe. This highlights the need for Improved blood-donor screening and more informative biomarker studies, particularly among repeat donors and children.

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Introduction: Limited data were available on the effectivenessfour years after Homo or Hetero prime-boost with 10 µg Hansenulapolymorpha recombinant hepatitis B vaccine (HepB-HP) and 20 µgChinese hamster ovary cell HepB (HepB-CHO). Methods: A crosssectional study was performed in maternalhepatitis B surface antigen (HBsAg)-negative children whoreceived one dose of 10 µg HepB-HP at birth, Homo or Heteroprime-boost with 10 µg HepB-HP and 20 µg HepB-CHO at 1 and 6months. HBsAg and hepatitis B surface antibody (anti-HBs) fouryears after immunization were quantitatively detected by achemiluminescent microparticle immunoassay (CMIA). Results: A total of 359 children were included; 119 childrenreceived two doses of 10 µg HepB-HP and 120 children receivedtwo doses of 20 µg HepB-CHO, called Homo prime-boost; 120children received Hetero prime-boost with 10 µg HepB-HP and 20µg HepB-CHO. All children were HBsAg negative. The geometricmean concentration (GMC) and overall seropositivity rate (SPR) ofanti-HBs were 59.47 (95%CI: 49.00 - 72.16) mIU/ml and 85.51%(307/359). Nearly 15% of the study subjects had an anti-HBsconcentration < 10 mIU/ml and 5.01% had an anti-HBsconcentration ≤ 2.5 mIU/ml. The GMC of the 20 µg CHO Homoprime-boost group [76.05 (95%CI: 54.97 - 105.19) mIU/ml] washigher than that of the 10 µg HP Homo group [45.86 (95%CI:31.94 - 65.84) mIU/ml] (p = 0.035). The GMCs of the Heteroprime-boost groups (10 µg HP-20 µg CHO and 20 µg CHO-10 µgHP) were 75.86 (95% CI: 48.98 - 107.15) mIU/ml and 43.65(95%CI: 27.54 - 69.18) mIU/ml, respectively (p = 0.041). Aftercontrolling for sex influence, the SPR of the 20 µg CHO Homoprime-boost group was 2.087 times than that of the 10 µg HPHomo group. Discussion: The HepB booster was not necessary in the generalchildren, Homo/Hetero prime-boost with 20 µg HepB-CHO wouldincrease the anti-HBs concentration four years after immunization,timely testing and improved knowledge about the self-pay vaccinewould be good for controlling hepatitis B.

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BACKGROUND: The Hepatitis B virus (HBV) is transmitted through contaminated blood or bodily fluids. Globally, over 81 million blood units are donated annually, a crucial therapeutic procedure without alternatives. However, blood-borne infections, including HBV, pose a significant hurdle to safe transfusions, especially in HBV-endemic regions like Somalia with limited screening. Therefore, this study aims to estimate the prevalence of Hepatitis B virus infection and identify risk factors associated with it among blood donors in Mogadishu, Somalia. METHOD: A hospital-based cross-sectional study was conducted between February and April 2023. Research tools included a 5-ml blood sample and a structured questionnaire. The presence or absence of HB markers was determined using a multi-HB rapid test and CDC's HB marker interpretation guideline. Logistic regression was used in univariate and multivariate models to identify risk factors associated with HBV infection, with significance set at a p-value < 0.05 in the final model. RESULT: A total of 494 blood donors were recruited for this study; 93.9% were male, with a mean age of 31.5 (SD = 8.11). The prevalence of Hepatitis B virus (HBV) infection among blood donors was 9.7%, with a 95% CI of 7.1-12.3. In multivariable logistic regression, those with a monthly income of less than 200 USD (AOR = 5.20, 95% CI = 1.61-16.79), those with an income between 200 and 400 (AOR = 3.59, 95% CI = 1.38-9.34), Jobless blood donors (AOR = 3.78, 95% CI = 1.17-12.20), those in business occupations (AOR = 3.35, 95% CI = 1.24-9.08), those with a history of STDs (AOR = 4.83, 95% CI = 2.03-11.50), those without a history of HB vaccine (AOR = 13.81, 95% CI = 2.46-77.41), those with a history of tooth extraction (AOR = 6.90, 95% CI = 2.66-17.88), and those who shared sharp equipment (AOR = 2.90, 95% CI = 1.07-7.82) were more likely to become infected with the Hepatitis B virus (HBV) compared to their counterparts. CONCLUSION: This study highlights a high prevalence of Hepatitis B virus (HBV) infection. Implementation efforts against HBV infection should specifically focus on low-income individuals, the jobless, and donors with a history of STD to mitigate the burden of HBV infection and promote safer blood donation. In addition, discouraging the sharing of sharp equipment, improving infection control practices during tooth extraction procedures, and enhancing HB vaccination uptake, particularly among individuals lacking a history of HB vaccine, is highly recommended.

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Introduction: The World Health Organization (WHO) recommends vaccination against hepatitis B as soon as possible following birth for all infants, regardless of prematurity. Hepatitis B vaccination at birth is clearly justified, represents a crucial step in the global control of perinatally acquired hepatitis B and there are no safety concerns in infants born at term. However, there is limited information on the safety of the hepatitis B vaccine in preterm infants, whose immune responses and morbidity risk differ from those in infants born at term. Objectives: The objectives of this paper are to systematically review the literature regarding the safety and risk of adverse events following immunisation (AEFIs) associated with the administration of the hepatitis B vaccine (monovalent or as part of a combination vaccine) to preterm infants. Methods: We performed a search for relevant papers published between 1 January 2002 and 30 March 2023 in the Ovid MEDLINE, Ovid Embase, Cochrane Central Register of Controlled Trials and CINAHL Plus databases. Two authors independently reviewed and analysed each article to include in the systematic review. Narrative synthesis is presented. Results: Twenty-one relevant papers were identified and included in this systematic review. The vast majority of data pertained to multi-antigen (combination) vaccine preparations and vaccination episodes from 6 weeks of age onwards. We found no publications investigating the timing of the birth dose of the hepatitis B vaccine, and AEFI reporting was exclusively short-term (hours to days following administration). There was substantial variability in the reported rate of AEFIs between studies, ranging from 0% to 96%. Regardless of frequency, AEFIs were mostly minor and included injection site reactions, temperature instability and self-limiting cardiorespiratory events. Six studies reported serious adverse events (SAEs) such as the requirement for escalation of respiratory support. However, these occurred predominantly in high-risk infant populations and were rare (~1%). Using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, the certainty of evidence was assessed as very low. Conclusions: Despite substantial variability between the relatively small number of published studies in terms of cohort selection, definitions, vaccine preparations and reporting, hepatitis B-containing vaccines (mostly as combination vaccines) appear to be relatively well tolerated in preterm infants from 6 weeks of age. Research focusing on the safety of hepatitis B vaccine in preterm infants specifically within 7 days of birth is lacking, particularly regarding long-term morbidity risk. Further research in this area is required.

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Background: The immune response to hepatitis B vaccine may be influenced by numerous factors, and patients with non/low response re-exposed to hepatitis B virus remain susceptible. Thus, a better understanding of the underlying mechanisms of non/low immune response in infants born to Hepatitis B surface antigen (HBsAg)-positive mothers is essential. Methods: 100 infants born to HBsAg-positive mothers from 2015 to 2020 were enrolled in the study, further divided into the non/low response group (n=13) and the moderate strong response group (n=87) based on the quantification of hepatitis B surface antibody at 12 months of age. The differential expression of 48 immune-related cytokines in the two groups was compared and analyzed in detail. The key cytokines were further identified and clinically predictive models were developed. Results: We found that 13 cytokines were lowly expressed and one cytokine was highly expressed in the non/low response group, compared with the moderate strong response group at birth. In addition, 9 cytokines were lowly expressed and one cytokine was highly expressed in the non/low response group at 12 months of age. Furthermore, we found that IL-5 and HGF were promising predictors for predicting the immunization response to hepatitis B vaccine in infants, and the combination of the two cytokines showed the best predictive efficiency, with an area under the curve (AUC) value of 0.844. Conclusion: The present study provides a theoretical basis on cytokines for developing and implementing effective immunotherapies against non/low immune response in infants born to HBsAg-positive mothers.

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PURPOSE: The purpose of this study was to investigate immunological variations between a group that received the hepatitis B vaccine and a non-vaccine group. We focused on a cohort that achieved HBsAg seroclearance after Peg-IFNα treatment of CHB. METHODS: We enrolled twenty-eight individuals who achieved HBsAg seroclearance after Peg-IFNα treatment. They were divided into two groups: a vaccine group (n = 14) and a non-vaccine group (n = 14). We assessed lymphocyte subpopulations, B cell- and T cell-surface costimulatory/inhibitory factors, cytokines and immunoglobulin levels were detected at different time points to explore immune-function differences between both groups. RESULTS: The seroconversion rate in the vaccine group at 24 weeks post-vaccination was 100%, which was significantly higher (p = 0.006) than that of the non-vaccine group (50%). Additionally, more individuals in the vaccine group exhibited anti-HBs levels exceeding 100 IUs/L and 300 IUs/L compared to the non-vaccine group (p < 0.05). The vaccine group demonstrated significantly increase total B cells and class-switched B cells at 24 weeks and plasma cells, CD80+B cells, Tfh cells, and ICOS+Tfh cell at 12 weeks, compared with baseline levels (p < 0.05). Conversely, Bregs (CD24+CD27+ and CD24+CD38high) decreased significantly at 24 weeks (p < 0.05). None of the above changes were statistically significance in the non-vaccine group (p > 0.05). Total IgG increased significantly in the vaccine group, and IL-2, IL-5, and IL-6 concentrations increased significantly at week 24 (p < 0.05). Differences in various types of cytokines and immunoglobulins in the plasma of the non-vaccine group were not significant (p > 0.05). Anti-HBs titers positively correlated with Th1/Th2 cells at 24 weeks (r = 0.448 and 0.458, respectively, p = 0.022 and 0.019, respectively), and negatively with CD24+CD38highBreg cells (r = -0.402, p = 0.042). CONCLUSIONS: After achieving HBsAg seroclearance through Peg-IFNα treatment for CHB, administering the hepatitis B vaccine significantly increased anti-HBs-seroconversion rates and antibody levels. We also observed significant immunological differences between the vaccine and non-vaccine groups. Specifically, the vaccine group exhibited significant increases in B cells, plasma cells, and Tfh cells, while Breg levels was significantly lower. These immunological changes are likely conducive to the production of anti-HBs antibodies. However, in the non-vaccine group, the observed changes were not significantlly significant.

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BACKGROUND: Globally, 257 million people have chronic hepatitis. Even though a safe and effective prophylactic vaccine against HBV infection has been available, it causes significant morbidity and mortality. HBV vaccines were designed to improve or modulate the host immune responses. The effectiveness of the vaccine is determined by measuring serum hepatitis B surface antibody (Anti-HBs) level. Therefore, this systematic review aimed to evaluate the effectiveness of hepatitis B vaccine among vaccinated children. METHODS: Preferred reporting items for systematic review and meta-analysis (PRISMA) guidelines was applied for systematically searching of different databases. Only cross-section studies measuring the level of anti-HBs of vaccinated children were included. The seroprotective level with anti-HBs > 10mIU/ml was extracted. The meta-analysis was performed using statistical software for data sciences (STATA) version 14. Effectiveness estimates were reported as a proportion of anti-HBs level. The heterogeneity between studies was evaluated using the I2 test, and I2 > 50% and/or P < 0.10 was considered significant heterogeneity. Significant publication bias was considered when Egger's test P-value < 0.10. The new castle Ottawa scale was used to assess the quality of the studies. RESULTS: A pooled sample size of the included papers for meta-analysis was 7430. The pooled prevalence of seroprotected children was 56.95%, with a heterogeneity index (I2) of 99.4% (P < 0.001). 35% of the participants were hypo-responders (10-99mIU/ml) and 21.46% were good responders (> 100mIU/ml). Based on subgroup analysis using country of studies conducted, the highest prevalence of anti-HBs was 87.00% (95% CI: 84.56, 89.44), in South Africa, and the lowest was 51.99% (95% CI: 20.41-83.58), with a heterogeneity index I2 = 70.7% (p = 0.009) in Ethiopia. CONCLUSION AND RECOMMENDATIONS: Hepatitis B vaccine seroprotective level in the current pooled analysis have suboptimal, which failed to demonstrate consistent effectiveness for global hepatitis B virus elimination plan in 2030. Using consistent age group may have a significant value for the decision of the HB vaccine effectiveness. A significant heterogeneity was observed both in studies conducted in Ethiopia and Egypt. Therefore, the impact of HB vaccination on the prevention of hepatitis B virus infection should be assessed regularly in those countries. Future meta-analysis is needed to investigate all possible vaccines in a separate way of reviewing, which will lead to a strong conclusion and recommendations.

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Previous studies did not provide substantial evidence for long-term immune persistence after the hepatitis B vaccine (HepB) in preterm birth (PTB) children. Consequently, there is ongoing controversy surrounding the booster immunization strategy for these children. Therefore, we conducted a retrospective cohort study to evaluate the disparities in immune persistence between PTB children and full-term children. A total of 1027 participants were enrolled in this study, including 505 PTB children in the exposure group and 522 full-term children in the control group. The negative rate of hepatitis B surface antibody (HBsAb) in the PTB group was significantly lower than that in the control group (47.9% vs. 41.4%, p = .035). The risk of HBsAb-negative in the exposure group was 1.5 times higher than that in the control group (adjusted odds ratio [aOR] = 1.5, 95% confidence interval [CI]: 1.1-2.0). The geometric mean concentration (GMC) of HBsAb was much lower for participants in the exposure group compared to participants in the control group (9.3 vs. 12.4 mIU/mL, p = .029). Subgroup analysis showed that the very preterm infants (gestational age <32 weeks) and the preterm low birth weight infants (birth weight <2000 g) had relatively low GMC levels of 3.2 mIU/mL (95% CI: 0.9-11.1) and 7.9 mIU/mL (95% CI: 4.2-14.8), respectively. Our findings demonstrated that PTB had a significant impact on the long-term persistence of HBsAb after HepB vaccination. The very preterm infants (gestational age <32 weeks) and the preterm low birth weight infants (birth weight <2000 g) may be special populations that should be given priority for HepB booster vaccination.

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