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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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Pessoal de Saúde , Vacinas contra Hepatite B , Hepatite B , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Adjuvantes Imunológicos/administração & dosagem , Hepatite B/prevenção & controle , Anticorpos Anti-Hepatite B/sangue , Vacinas contra Hepatite B/administração & dosagem , Estudos Prospectivos , VacinaçãoRESUMO
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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Hepatite B , Fenilbutiratos , Nascimento Prematuro , Criança , Feminino , Humanos , Lactente , Recém-Nascido , Peso ao Nascer , Seguimentos , Hepatite B/epidemiologia , Hepatite B/prevenção & controle , Anticorpos Anti-Hepatite B , Antígenos de Superfície da Hepatite B , Vacinas contra Hepatite B , Recém-Nascido Prematuro , Nascimento Prematuro/epidemiologia , Estudos Retrospectivos , VacinaçãoRESUMO
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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Antígenos de Superfície da Hepatite B , Hepatite B Crônica , Humanos , Interferon-alfa/uso terapêutico , Soroconversão , Hepatite B Crônica/tratamento farmacológico , Vacinas contra Hepatite B/uso terapêutico , Citocinas , Anticorpos Anti-Hepatite B , Vacinação , Imunidade , Antígenos E da Hepatite B , Antivirais/uso terapêutico , Polietilenoglicóis/uso terapêuticoRESUMO
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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Hepatite B , Vacinas , Masculino , Humanos , Adulto , Feminino , Vírus da Hepatite B , Doadores de Sangue , Prevalência , Estudos Transversais , Somália/epidemiologia , Hepatite B/epidemiologia , Fatores de RiscoRESUMO
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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Vacinas contra Hepatite B , Hepatite B , Criança , Humanos , Eficácia de Vacinas , Vírus da Hepatite B , Hepatite B/epidemiologia , Hepatite B/prevenção & controle , Anticorpos Anti-Hepatite B , EtiópiaRESUMO
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 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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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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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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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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Pessoal de Saúde , Vacinas contra Hepatite B , Hepatite B , Cobertura Vacinal , Humanos , Cobertura Vacinal/estatística & dados numéricos , Estudos Transversais , Pessoal de Saúde/estatística & dados numéricos , Feminino , Masculino , Hepatite B/prevenção & controle , Adulto , Vacinas contra Hepatite B/administração & dosagem , Pessoa de Meia-Idade , Inquéritos e Questionários , China/epidemiologia , Adulto Jovem , Vacinação/estatística & dados numéricosRESUMO
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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Vacinas contra Hepatite B , Hepatite B , Recém-Nascido , Lactente , Feminino , Humanos , Antígenos de Superfície da Hepatite B , Interleucina-5 , Citocinas , Vacinação , Imunidade , Fator de Crescimento de HepatócitoRESUMO
Background and aim: Around 2% of newborns are at risk of hepatitis B virus (HBV) infection from their mothers. To prevent this, infants born to HBsAg-positive mothers are given hepatitis B immune globulin (HBIG) and hepatitis B (HB) vaccine as immunoprophylaxis. This study aims to investigate the efficacy of immunoprophylaxis in infants born to HBsAg-positive mothers and the contributing factors. Methods: The study was conducted on a group of 87 children, ranging from nine months to under 36 months, born to HBsAg-positive mothers and received immunoprophylaxis within 24 h after birth followed by a national immunization schedule at the Community Health Center (CHC) in three administrative cities of DKI Jakarta. We measured the levels of HBsAg and anti-HBs, and utilized ordinal logistic regression models to identify factors that influence the anti-HBs titers after vaccination. Results: Out of 87 children, only one child had positive HBsAg results. The data showed that 88.5% of the children had seroprotection with anti-HBs levels ≥10 mIU/mL. Additionally, 48.3% of the children had a high protective response with anti-HBs levels ≥100 mIU/mL, while 11.5% had a non-protective response. Children under one year of age, with a family history of HBV carriers, and who received five doses of the HB vaccine exhibited higher levels of anti-HBs titer category with adjusted OR 3.9 (95%CI: 1.3-11.6), 5.3 (95%CI: 1.1-27.4), and 8.3 (95%CI: 2-34.8), respectively. Conclusion: The administration of HBIG and HB vaccine successfully prevented vertical transmission, resulting in a high seroprotection rate.
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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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Cricetulus , Anticorpos Anti-Hepatite B , Antígenos de Superfície da Hepatite B , Vacinas contra Hepatite B , Hepatite B , Imunização Secundária , Vacinas Sintéticas , Humanos , Vacinas contra Hepatite B/imunologia , Vacinas contra Hepatite B/administração & dosagem , Antígenos de Superfície da Hepatite B/imunologia , Feminino , Animais , Masculino , Hepatite B/prevenção & controle , Hepatite B/imunologia , Anticorpos Anti-Hepatite B/sangue , Anticorpos Anti-Hepatite B/imunologia , Células CHO , Vacinas Sintéticas/imunologia , Vacinas Sintéticas/administração & dosagem , Estudos Transversais , Criança , Lactente , Pré-Escolar , Vírus da Hepatite B/imunologiaRESUMO
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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Abstract Introduction: Hepatitis B virus (HepB) infection is a global health problem with increasing cause of morbidity and mortality.Hemodialysis patients are especially vulnerable to HepB infection due to uremia-related immune dysfunction, frequent interventions they exposed, and health-care personnel's unsafe care. The vaccination against HepB confers the primary preventive measure. However, unresponsiveness to vaccination constitutes a major problem. Several factors can influence the immune response to vaccines but human genetic variations are thought to strongly militate the variability in vaccine responsiveness. We aimed to determine the association with specific HLA alleles and response to HepB vaccination in hemodialysis patients. Methods: The study included in-center hemodialysis patients. We retrospectively collected data regarding demographic, clinical, and laboratory features including anti-HBs antibody, antibody to hepatitis C (anti-HCV), anti-HIV, and specific HLA class I and II alleles (HLA-A, HLB, HLA-DR) from electronical medical record system. The frequencies of HLA class I and II antigens in nonresponders and responders were analyzed. Results: The most commonly observed HLA alleles in patients were DQA1*01 (%73.7), DQA1*05 (%57.9), DQB1*03 (%53.8), DQB1*05 (%38.5), and DRB1*11 (%37.3), respectively. The frequency of HLA-B40 allel was significantly higher in nonresponders (p=0.02, OR=6.25, 95%CI =1.33-29.3). HLA-DQA1*01 and HLA-DQB1*05 alleles were observed significantly more in responders (p=0.019, OR =6.9, 95% CI=1.40-33.91, andp=0.028, OR =10, 95% CI=1.12-88.91, respectively). Conclusion: This is the first study to our knowledge demonstratingthe association between antibody response to HBsAg and HLA-B40, HLA-DQA1*01, and HLA-DQB1*05 alleles in Turkish hemodialysis patients.
Resumen Introducción: La infección por el virus de la hepatitis b (VHB) constituye un problema de salud mundial con una morbimortalidad cada vez mayor.Los pacientes que reciben hemodiálisis están particularmente expuestos a una infección por el virus de la hepatitis b debido a una disfunción del sistema inmunitario relacionada con la uremia, las intervenciones a las que se someten frecuentemente y prácticas poco seguras por parte del personal de salud. La vacuna contra el VHB constituye la medida preventiva principal. Sin embargo, la falta de respuesta a la vacuna supone un gran problema. Existen varios factores que pueden influir sobre la respuesta inmunitaria a la vacuna, pero se cree que las variaciones genéticas humanas tienen una gran incidencia sobre la variación en la respuesta a la vacuna. El objetivo de este trabajo fue determinar la relación entre alelos HLA específicos y la respuesta a la vacuna contra el VHB en pacientes que reciben hemodiálisis. Material y métodos: El estudio incluyó pacientes en hemodiálisis hospitalaria. Se recopilaron datos retrospectivamente del sistema electrónico de registros médicos sobre características demográficas, clínicas y de laboratorio, incluidos anticuerpos anti-HBs, anticuerpos contra la hepatitis C (anti-VHC), anti-VIH y alelos HLA específicos de clase I y II (HLA-A, HLA-B, HLA-DR). Se analizaron las frecuencias de los antígenos HLA clase I y II en pacientes que no respondían y en aquellos que sí lo hacían. Resultados: Los alelos HLA más comúnmente observados en pacientes fueron DQA1 * 01 (73,7%); DQA1 * 05 (57,9%); DQB1 * 03 (53,8%); DQB1 * 05 (38,5%), y DRB1 * 11 (37.3%), respectivamente. La frecuencia del alelo HLA-B40 fue significativamente mayor en los que no respondieron (p=0,02; OR = 6,25; IC 95% = 1,33-29,3). Se observó que los alelos HLA-DQA1*01 y HLA-DQB1*05 aparecían mayormente en los pacientes que respomdían (p=0,019; OR = 6,9; IC 95% = 1,40-33,91, y p=0,028; OR=10; IC 95% = 1,12- 88,91, respectivamente). Conclusión: Este es el primer estudio que conocemos que demuestra la asociación entre la respuesta de anticuerpos a HBsAg y a alelos HLA-B40, HLA-DQA1*01 y HLA-DQB1*05 en pacientes turcos en hemodiálisis.
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Introducción: la hepatitis B (HB) sigue siendo un importante problema de Salud Pública debido a las consecuencias que acarrea en los pacientes infectados. Entre los grupos de alto riesgo de adquirir este virus se encuentran los pacientes con enfermedad renal crónica (ERC) en tratamiento hemodialítico, por lo que la vacunación constituye un importante método de prevención y protección contra el virus de la hepatitis B (VHB). Objetivos: determinar el nivel de antiHBsAg y hallar la prevalencia de respuesta inadecuada a la vacuna contra la HB. Detectar los factores de riesgo asociados a la falta de respuesta inmunológica a la vacuna contra HB. Metodología: estudio observacional, descriptivo, prospectivo, de corte transverso, con componente analítico. Se incluyeron pacientes adultos con ERC en tratamiento hemodialítico trisemanal del Hospital Nacional de Itauguá durante el 2015. A todos se les determinó antiHBsAg. Resultados: se incluyeron 89 sujetos, de los cuales 47% tuvieron una respuesta inadecuada a la vacuna contra el VHB, con un leve predominio del sexo masculino. Conclusiones: la frecuencia de respuesta inadecuada a la vacuna es 47%. La edad, el hábito tabáquico, las comorbilidades y el estado de nutrición por IMC resultaron como factores de riesgo no significativos en la respuesta inadecuada a la vacuna contra el VHB, mientras que los años de hemodiálsis y la uremia se relacionaron de manera significativa a esta mala respuesta.
Introduction: Hepatitis B (HB) is still an important problem of Public Health due to the consequences in the infected patients. Among the groups with high risk of acquiring this virus, there are the patients with chronic renal disease (CRD) receiving hemodialysis treatment. Vaccination is an important prevention and protection method against the hepatitis B virus (HBV). Objectives:To determine the level of anti-HBsAg, find the prevalence of inadequate response to the HB vaccine and detect the risk factors associated with the lack of immunological response to HB vaccine. Methodology: This was a cross-sectional prospective descriptive observational study with analytical component. Adult patients with CRD receiving hemodialysis treatment three times a week in the National Hospital of Itauguá during 2015 were included. Anti-HBsAg was determined in all of them. Results: Eighty nine patients were included and 47% of them had inadequate response to HB vaccine with a slight predominance of men. Conclusions: The frequency of inadequate response to the vaccine was 47%. Age, smoking habits, co-morbidities and nutritional state by BMI were non-significant risk factors in the inadequate response to HB vaccine while years of hemodialysis and uremia were significantly related to this bad response.
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For over 20 years, the hepatitis B (HB) vaccine has been produced by the expression of the viral gene encoding the hepatitis B surface antigen (HBsAg) in yeast. According to the data from WHO, the hepatitis B vaccines are generally stable for up to three years when stored at 2 ºC to 8 ºC. The purpose of this study was to evaluate whether the hepatitis B vaccine, at the time of their release, the quality criteria of this product were maintained seven years after the expiration date. Vaccine vials in multi-dose (10 and 05 doses) and three lots from each manufacturer (A, B and C) were analyzed. All batches were assayed for visual appearance, potency, bacterial endotoxin, thiomersal amount, aluminum hidroxyde contents and pH by means of validated tests. The nine lots evaluated seven years after the expiration date showed similar concentrations when compared to those demonstrated at the time of batches release by the National Institute for Quality Control in Health (INCQS). No significant change in the quality of the hepatitis B vaccine after the expiration date was confirmed. These data might be useful to subsidize a future evaluation for reviewing an extension of the vaccines shelf life.
As vacinas contra a hepatite B são produzidas pela expressão do gene viral codificado para o antígeno de superfície do vírus da hepatite B (HBsAg) em levedura, há mais de 20 anos. De acordo com os dados da OMS, a vacina de hepatite B tem até três anos de estabilidade quando armazenada entre 2 ºC e 8 ºC. O objetivo deste estudo foi de avaliar se, no momento da liberação, os critérios de qualidade da vacina de hepatite B foram mantidos após sete anos da data de validade. Foram analisados frascos de vacinas multi-dose (10 e 5 doses), sendo três lotes de cada produtor (A, B e C). Todos os lotes foram avaliados quanto às características de aparência visual, potência, endotoxina bacteriana, presença de timerosal, conteúdo de hidróxido de alumínio e pH por meio de testes validados. Os nove lotes avaliados sete anos após a data de expiração tiveram resultados similares quando comparados às concentrações na época de liberação dos lotes, realizada pelo Instituto Nacional de Controle de Qualidade em Saúde (INCQS). Os estudos confirmaram a manutenção da qualidade da vacina após o período de expiração. Estes dados podem subsidiar uma futura avaliação para extensão do prazo de validade das vacinas.
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Controle de Qualidade , Hepatite B , Prazo de Validade de Produtos , VacinasRESUMO
The protective anti-HBs titres were examined six-year post-immunisation with the Brazilian recombinant hepatitis B vaccine. After the primary vaccination, all adolescents (n = 89) responded with protective anti-HBs titres and had a geometric mean titre (GMT) of 4031.8 mIU/mL. In 2010, 94.5% maintained protective anti-HBs (> 10 mIU/mL) antibodies, with a GMT of 236.0 mIU/mL. A positive correlation was observed between the anti-HBs titres after the primary vaccination and the titres at the six-year follow-up (p < 0.01). Eleven subjects showed anti-HBs titres suggestive of a natural booster. Prostitution and tattoos/piercings were marginally associated with natural boosters in the multivariate analysis. This study showed the first data on anti-HBs persistence following the Brazilian hepatitis B vaccine in sexually active individuals and highlights its effectiveness in the medium term.
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Adolescente , Criança , Humanos , Adulto Jovem , Anticorpos Anti-Hepatite B/imunologia , Vacinas contra Hepatite B/administração & dosagem , Hepatite B/prevenção & controle , Brasil , Seguimentos , Anticorpos Anti-Hepatite B/sangue , Vacinas contra Hepatite B/imunologia , Hepatite B/imunologiaRESUMO
Recently, it was suggested that maternal hepatitis B surface antigen antibodies (anti-HBs) acquired transplacentally could play a negative role in newborn infants' immune response to the hepatitis B vaccine. We compared the hepatitis B virus (HBV) vaccine response in infants born to mothers previously vaccinated against HBV (n = 91) to infants born to mothers who were not previously vaccinated (n = 221). All newborn infants received three intramuscular doses (10 μg) of HBV vaccine (Butang®) at 0,1 and six months. The first dose was administered at the maternity hospital within 12 h of birth. The geometric mean titres of anti-HBs were not different among newborn infants born to mothers who were anti-HBs-negative (492.7 mIU/mL) and anti-HBs-positive (578.7 mIU/mL) (p = 0.38). Eight infants did not respond to the HBV vaccine. Of them, six were born to anti-HBs-negative mothers and two were born to mothers with anti-HBs titres less than 50 mlU/mL. Despite the mother's anti-HBs-positive status, our data show a good immunogenicity of the Brazilian HBV recombinant vaccine in neonates.
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Adulto , Humanos , Recém-Nascido , Masculino , Anticorpos Anti-Hepatite B/sangue , Antígenos de Superfície da Hepatite B/sangue , Vacinas contra Hepatite B/imunologia , Vírus da Hepatite B/imunologia , Hepatite B , Anticorpos Anti-Hepatite B/imunologia , Antígenos de Superfície da Hepatite B/imunologia , Hepatite B/imunologiaRESUMO
Para avaliar os fatores de predição da não adesão à vacina contra o vírus da hepatite B (VHB) em adolescentes escolares de baixa renda da Região Metropolitana de Goiânia, Goiás, 304 indivíduos suscetíveis ao VHB, matriculados em duas escolas, foram entrevistados e a vacina contra hepatite foi oferecida. Somente 195 (64 por cento) adolescentes aceitaram a primeira dose da vacina. Por outro lado, 182/195 (93,3 por cento) receberam o esquema completo. Verificou-se que fatores escolares exerceram um papel na aceitação da vacina, uma vez que a escola B e turno noturno foram independentemente associados à não adesão à vacina. Os achados deste estudo ratificam a baixa aceitação da vacina contra hepatite B em adolescentes e evidenciam a necessidade de programas de educação em saúde para sensibilização desse grupo em relação à vacinação, e reforçam a importância de estratégias de imunização na escola para o cumprimento do esquema completo da vacina contra o VHB nesta população-alvo.
To evaluate the predictor factors for non-acceptance of hepatitis B vaccine among low-income adolescent students in the Goiânia Metropolitan Region, Goiás State, Brazil. In this study, 304 HBV-susceptible individuals enrolled in two schools were interviewed, and the HBV vaccine was offered. Only 195 (64 percent) of adolescents accepted the first dose of vaccine. On the other hand, 182/195 (93.3 percent) received the full HBV vaccine scheme. School factors played a role in vaccine acceptance, as School B and night classes were independently associated with non-acceptance of hepatitis B vaccination. The findings of this study ratify the low acceptance of hepatitis B vaccine among adolescents, highlighting the need for health education programs aiming at this group for hepatitis B vaccinations, while buttressing the importance of school-based vaccination strategies for attaining full HBV immunization of this target population.