Efficacy and safety of hepatitis B vaccine: an umbrella review of meta-analyses.

BACKGROUND: There is a lack of synthesis of literature to determine hepatitis B vaccine (HepB) strategies for hepatitis B virus (HBV) supported by quality evidence. We aimed to explore the efficacy and safety of HepB strategies among people with different characteristics. RESEARCH DESIGN AND METHODS: PubMed, Cochrane Library, Embase, and Web of Science were searched for meta-analyses comparing the efficacy and safety of HepB up to July 2023. RESULTS: Twenty-one meta-analyses comparing 83 associations were included, with 16 high quality, 4 moderate, and 1 low quality assessed by AMSTAR 2. Highly suggestive evidence supports HepB booster and HepB with 1018 adjuvant (HBsAg-1018) for improved seroprotection, and targeted and universal HepB vaccination reduced HBV infection Suggestive evidence indicated that targeted vaccination decreased the rate of hepatitis B surface antibody positivity and booster doses increased seroprotection in people aged 10-20. Weak evidence suggests potential local/systemic reaction risk with nucleotide analogs or HBsAg-1018. Convincing evidence shows HLA-DPB1*04:01 and DPB1*04:02 increased, while DPB1*05:01 decreased, hepatitis B antibody response. Obesity may reduce HepB seroprotection, as highly suggested. CONCLUSION: Targeted vaccination could effectively reduce HBV infection, and adjuvant and booster vaccinations enhance seroprotection without significant reaction. Factors such as obesity and genetic polymorphisms may affect the efficacy.

A autonomia do adolescente em relação ao direto de imunização contra infecções sexualmente transmissíveis: revisão bibliográfica / La autonomía de los adolescentes en relación con la inmunización directa contra las infecciones de transmisión sexual: revisión bibliográfica / The autonomy of adolescents in relation to the direct of immunization against sexually transmitted infections: bibliographic review

O presente estudo trata-se de uma análise na literatura sobre o aspecto bioético da autonomia em relação a imunização contra Hepatite B e HPV na adolescência. Foi realizada uma revisão bibliográfica baseada no método prisma onde foram incluídos artigos em português e inglês os quais foram pesquisados nas plataformas Scientific Electronic Library Online (SciELO), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) e National Library of Medicine (PUBMED), utilizando os seguintes descritores Hepatitis B Vaccines, bioethics, Humans. Os resultados demostraram a eficiência dos profissionais de saúde no contato com o indivíduo e o convencimento deste através de um diálogo aberto e criação de vínculos. Evidenciou-se ainda o estudo evidenciou o direito a autonomia progressiva do paciente, no qual este ganha o direito a algumas escolhas como as imunizações de doenças sexualmente transmissíveis, como é o caso da Hepatite B e HPV, no entanto é necessário que o adolescente seja instruído sobre a imunização. Assim sendo, reconhece-se o direito a autonomia progressiva do adolescente, referente a escolha das imunizações contra a Hepatite B e HPV, entretanto, deve-se considerar que estes indivíduos sejam instruídos sobre os benefícios individuais e/ou coletivos da vacinação, contemplados por atividades de educação em saúde por profissionais qualificados, objetivando ampliar a cobertura global de imunização com doenças que caracterizam problemas de saúde pública.

El presente estudio es un análisis de la literatura sobre el aspecto bioético de la autonomía en relación con la inmunización contra la Hepatitis B y el VPH en la adolescencia. Se realizó una revisión bibliográfica basada en el método del prisma, que incluyó artículos en portugués e inglés que fueron buscados en la Biblioteca Científica Electrónica en Línea (SciELO), Literatura Latinoamericana y del Caribe en Ciencias de la Salud (LILACS) y la Biblioteca Nacional de Medicina (PUBMED), utilizando los siguientes descriptores Vacunas Hepatitis B, bioética, Humanos. Los resultados demostraron la eficiencia de los profesionales de la salud en contactar al individuo y convencerlo a través de un diálogo abierto y creación de vínculos. También se evidenció que el estudio evidenció el derecho del paciente a la autonomía progresiva, en la que adquiere el derecho a algunas opciones como las inmunizaciones de enfermedades de transmisión sexual, como la Hepatitis B y el VPH, sin embargo, es necesario que el adolescente sea educado sobre la inmunización. Por lo tanto, se reconoce el derecho del adolescente a la autonomía progresiva, en cuanto a la elección de las vacunas contra la Hepatitis B y el VPH, sin embargo, se debe considerar que estos individuos sean educados sobre los beneficios individuales y/o colectivos de la vacunación, contemplados por las actividades de educación en salud por profesionales calificados, con el objetivo de ampliar la cobertura mundial de inmunización con enfermedades que caracterizan los problemas de salud pública.

The present study is an analysis of the literature on the bioethical aspect of autonomy in relation to immunization against Hepatitis B and HPV in adolescence. A bibliographic review was carried out based on the prism method, which included articles in Portuguese and English which were searched on the Scientific Electronic Library Online (SCIELO), Latin American and Caribbean Literature on Health Sciences (LILACS) and the National Library of Medicine (PUBMED), using the following descriptors Hepatitis B Vaccines, bioethics, Humans. The results demonstrated the efficiency of health professionals in contacting the individual and convincing him/her through an open dialogue and creation of bonds. It was also evidenced the study evidenced the patient's right to progressive autonomy, in which he gains the right to some choices such as immunizations of sexually transmitted diseases, such as Hepatitis B and HPV, however it is necessary for the adolescent to be educated about immunization. Therefore, the adolescent's right to progressive autonomy is recognized, regarding the choice of immunizations against Hepatitis B and HPV, however, it must be considered that these individuals are instructed on the individual and/or collective benefits of vaccination, contemplated by health education activities by qualified professionals, aiming to expand the global coverage of immunization with diseases that characterize public health problems.

Immune response induced by recombinant pres2/S-protein and a pres2-S-protein fused with a core 18-27 antigen fragment of hepatitis B virus compared to conventional HBV vaccine.

Although comprehensive vaccination is the cornerstone of public health programs to control hepatitis B virus (HBV) infections, 5% of people who receive the existing vaccine do not develop proper immunity against HBV. To overcome this challenge, researchers have tried using various protein fragments encoded by the virus genome to achieve better immunization rates. An important antigenic component of HBsAg called the preS2/S or M protein has also received much attention in this area. The gene sequences of preS2/S and Core18-27 peptide were extracted from the GenBank (NCBI). Final gene synthesis was conducted with pET28. Groups of BALB/c mice were immunized with 10 µg/ml of recombinant proteins and 1 µg/ml CPG7909 adjuvant. Serum levels of IF-γ, TNF-α, IL-2, IL-4, and IL-10 were measured by ELISA assay method on spleen cell cultures on day 45, and IgG1, IgG2a, and total IgG titers obtained from mice serum were quantified on days 14 and 45. Statistical analysis did not show any significant difference between the groups regarding IF-γ level. There were, however, significant differences in terms of IL-2 and IL-4 levels between the groups receiving preS2/S-C18-27 with and without adjuvant and the groups receiving both preS2/S and preS2/S-C18-27 (Plus Recomb-Plus Recomb: the group of mice that received both preS2/S and preS2/S-C18-27 simultaneously). The strongest total antibody production was induced by immunization with both recombinant proteins without CPG adjuvant. The groups that received both preS2/S and preS2/S-C18-27, whether with or without adjuvant, were significantly different from those that received the conventional vaccine considering most abundant interleukins. This difference suggested that higher levels of efficacy can be achieved by the use of multiple virus antigen fragments rather than using a single fragment.

Prevalence, Risk Factors and Vaccine Response against Hepatitis B in People Aged 50 Years or Older.

Universal immunization against hepatitis B has contributed to reducing incidence of the disease, but older individuals remain susceptible to acquiring the hepatitis B virus worldwide. Thus, this study aimed to investigate the epidemiology of HBV infection in individuals aged 50 years and over in central Brazil and to evaluate the immunogenicity of the monovalent vaccine against hepatitis B in this age group using two vaccine regimens. METHOD: Initially, a cross-sectional and analytical study was carried out to investigate the epidemiology of hepatitis B. Then, individuals without proof of vaccination for hepatitis B were recruited for a phase IV randomized and controlled clinical trial using two vaccine regimens: Intervention Regimen (IR) (three doses of 40 µg at months 0, 1 and 6) vs. Comparison Regimen (CR) (three doses of 20 µg at months 0, 1 and 6). RESULTS: The overall prevalence of exposure to HBV was 16.6% (95% CI: 14.0%-9.5%). In the clinical trial, statistical differences in protective titers were observed (p = 0.007; IR 96% vs. CR 86%) and the geometric mean of anti-HBs titers was higher in individuals who received the IR (518.2 mIU/mL vs. 260.2 mIU/mL). In addition, the proportion of high responders was higher among those who received the IR (65.3%). CONCLUSION: reinforced doses should be used in individuals aged 50 years or older to overcome the lower efficacy of the vaccine against hepatitis B.

Factores individuales e institucionales asociados a la vacunación contra el virus de la hepatitis B en recién nacidos de hospitales de Lima y Callao

Introducción. La vacunación contra el virus de la hepatitis B (VHB) en recién nacidos es crucial para la prevención de la transmisión perinatal. Objetivo. Determinar factores individuales e institucionales asociados a la vacunación contra el VHB en las 12 y 24 primeras horas de vida. Métodos. Se diseñó un estudio transversal y multicéntrico. Los datos sobre la vacunación fueron recogidos de los padres y de la revisión de reportes. Los datos de los variables individuales de los recién nacidos y madres fueron recogidos de las historias clínicas. Los datos institucionales fueron recogidos de registros de atención inmediata y directamente del personal de inmunizaciones. Resultados. Se incluyó 777 recién nacidos en 10 establecimientos. En el análisis multinivel resultó favorable a la vacunación en las primeras 12 horas, el mayor tiempo de atención en los servicios de inmunizaciones (RP: 1,0; IC95%: 0,99 - 1,01). Para la vacunación dentro de las 24 horas de vida fue favorable la mayor cantidad de personal de enfermería en los servicios de vacunación (RP: 1,02; IC95%: 1,01 - 1,03) y desfavorable la mayor cantidad de partos al día de los establecimientos (RP: 0,99; IC95%: 0,99 - 0,997). No se identificó factores individuales. Conclusión. Factores institucionales, como el tiempo de atención, la cantidad de personal de enfermería y la cantidad de partos, estuvieron asociados con la vacunación contra el VHB en recién nacidos. Se requiere estrategias de mejora como la introducción de la vacunación en la atención inmediata del neonato para la prevención de la transmisión perinatal del VHB.

Introduction. Vaccination against hepatitis B Virus (HBV) in newborns is crucial for the prevention of perinatal transmission. Objective. To determine the individual and institutional factors associated with vaccine for HBV in newborns in the first 12 hours and 24 hours of life. Methods. A cross-sectional, multicenter-design study was conducted in high level public and private hospitals in Lima Metropolitana and Callao. Information on vaccination was obtained through consultations with parents and review of health service reports. Individual variables of the newborns and their mothers were obtained from the medical records of the newborns. Institutional data were collected from immediate care records and from health personnel responsible for the immunization program. Results. The study was conducted in 10 health facilities, including 777 newborns. In the multilevel analysis, the longest care time in the vaccination service was favorable for vaccination within 12 hours of life (PR: 1,0; 95% CI: 0,9995-1,01); while for vaccination within 24 hours of life was favorable the greater number of nursing personnel (RP: 1,02; IC95%: 1,01-1,03) and unfavorable the greater number of deliveries per day in the institution (RP:0,99; IC95%: 0,99-0,997). No individual factors related to vaccination were identified. Conclusions. Institutional factors, such as length of care, number of nursing staff, and number of deliveries, were associated with newborn HBV vaccination. Improvement strategies are required, such as the introduction of vaccination in the immediate care of the newborn for the prevention of perinatal transmission of HBV.

Hepatitis B vaccination coverage and serological status among health care workers exposed to occupational biological hazards.

Introduction: Health care workers are often exposed to hepatitis B infection during the course of their professional roles. Objectives: To analyze the hepatitis B vaccination coverage and the presence of antibodies against hepatitis B among health care professionals who were exposed to contaminated biological material at a hospital complex. Methods: This descriptive, retrospective, and quantitative study is based on the analysis of accident notification form data (n = 2,466) from a hospital complex covering the period between 2011 and 2020. Results: Among the affected individuals, women (69.5%), medical residents (35.7%), and nursing staff (25.5%) accounted for the highest proportion of hazards. Regarding vaccination status, 98% of the health care professionals reported being fully immunized, and antibodies were detected in 90.9% of the participants. Percutaneous exposure (76.4%) was the most prevalent type of hazard, with blood being the most commonly involved material (79.4%). Conclusions: The findings show that despite the risks of Hepatitis B contamination associated with the incidents, the professionals were protected due to the high vaccination coverage and evidence of immunity.

Introdução: Os trabalhadores da saúde estão constantemente expostos ao vírus da hepatite B durante a atividade laboral. Objetivos: Analisar a cobertura vacinal contra a hepatite B e a presença do anticorpo contra o antígeno de superfície da hepatite B (anti-HBs) entre profissionais e estudantes da área da saúde que sofreram acidente com material biológico em um complexo hospitalar universitário. Métodos: Tratou-se de um estudo descritivo, retrospectivo e quantitativo, baseado na análise dos dados das fichas de notificação (n = 2.466) dos acidentes ocorridos no período de 2011 a 2020. Resultados: As mulheres (69,5%), os residentes de medicina (35,7%) e os técnicos e auxiliares de enfermagem (25,5%) foram os que mais se acidentaram. Quanto ao estado vacinal dos trabalhadores de saúde para hepatite B, 98% declararam ter o esquema vacinal completo, e a presença de anti-HBs reagente foi detectada em 90,9%. Quanto às características dos acidentes, houve prevalência de exposição percutânea (76,4%), e sangue foi o material orgânico mais comumente envolvido (79,4%). Conclusões: Os achados demonstram que, apesar do risco de contaminação para o vírus da hepatite B associado a acidentes no ambiente de trabalho, os profissionais estavam protegidos devido à elevada cobertura vacinal e à imunidade comprovada.

Knowledge level of healthcare professionals regarding hepatitis B immunizatıon of newborns: example of Turkey

SUMMARY OBJECTIVE: The aim of this study was to evaluate healthcare professionals' knowledge level for hepatitis B immunization of term and preterm newborns. METHODS: The study was conducted with 213 midwives, nurses, and physicians between October 2021 and January 2022 in a province of Turkey. RESULTS: Participants had the least knowledge about the management of newborns with low birth weight born to hepatitis B-infected mothers (16%). CONCLUSION: The study revealed some knowledge gaps among healthcare professionals regarding hepatitis B immunization of newborns.

Effects of Decreased Immunization Coverage for Hepatitis B Virus Caused by COVID-19 in World Health Organization Western Pacific and African Regions, 2020.

The World Health Organization-designated Western Pacific Region (WPR) and African Region (AFR) have the highest number of chronic hepatitis B virus (HBV) infections worldwide. The COVID-19 pandemic has disrupted childhood immunization, threatening progress toward elimination of hepatitis B by 2030. We used a published mathematical model to estimate the number of expected and excess HBV infections and related deaths after 10% and 20% decreases in hepatitis B birth dose or third-dose hepatitis B vaccination coverage of children born in 2020 compared with prepandemic 2019 levels. Decreased vaccination coverage resulted in additional chronic HBV infections that were 36,342-395,594 in the WPR and 9,793-502,047 in the AFR; excess HBV-related deaths were 7,150-80,302 in the WPR and 1,177-67,727 in the AFR. These findings support the urgent need to sustain immunization services, implement catch-up vaccinations, and mitigate disruptions in hepatitis B vaccinations in future birth cohorts.

Comparison of Immune Response in Mice Immunized with Recombinant PreS2/S-C18-27 Protein Derived from Hepatitis B Virus with Commercial Vaccine.

Background & Objective: The vaccine available to prevent Hepatitis B virus disease is ineffective in 5% of people due to the use of HBsAg as a weak immunogenic factor. In the present study, PreS2/S fused to C18-27 peptide fragment as an effective antigen and is proposed as a promising vaccine candidate compared with the conventional vaccine prescribed in the vaccination program. Methods: After the synthesis of PreS2/S genes and C18-27 peptide fragment in pET28a, the recombinant protein was confirmed by Western blotting. The efficacy of the PreS2/S-C18-27 protein was compared with the conventional vaccine injected into five groups of rats. Finally, the cytokine level of IF-r, IL-2, IL-4, IL-10, TNF-a, IgG1, and IgG2a were measured using the ELISA method. Results: This study showed no significant difference between the recombinant vaccine group and PBS control group in the IF-r test, but there was a significant difference between groups testing IL-2 and IL-10. In addition, the group receiving the recombinant vaccine with CPG adjuvant at a dilution of 1/10 in the IgG total test on days 14 and 45 after the first injection showed a significant difference in comparison with other groups. Conclusion: This study showed no statistically significant difference between the recombinant protein vaccine group and the conventional vaccine group. The Th1- mediated immune responses obtained from recombinant proteins with and without CPG performed better than conventional vaccines, possibly due to the functional deficiency of the available vaccines.

Hepatitis B Vaccine and Multiple Sclerosis: Cause or Coincidence.

Multiple sclerosis (MS) is an autoimmune disease in which the body's immune system destroys myelin causing disruption of signals from the brain to the rest of the body. MS can be triggered by a variety of reasons. In this study, we present the case of a patient who developed neurological symptoms immediately (one day) after receiving the hepatitis B vaccine. The temporality of symptoms makes us question whether there is an association between the hepatitis B vaccine and MS. We would like to emphasize the importance of considering MS as a side effect of the hepatitis B vaccine and adding MS to the differential diagnosis of a patient who presents with neurological symptoms after receiving the hepatitis B vaccine.

Progress towards the elimination of hepatitis B in children in Colombia: A novel two-phase study approach.

The World Health Organization (WHO) has established a target to eliminate mother-to-child-transmission (EMTCT) of hepatitis B virus (HBV), defined as a prevalence of hepatitis B surface antigen (HBsAg) of ≤0.1% among children, by 2030. Using nationally representative serosurveys to verify achievement of this target requires large sample sizes and significant resources. We assessed the feasibility of a potentially more efficient two-phase method to verify EMTCT of HBV in Colombia. In the first phase, we conducted a risk assessment to identify municipalities at the highest risk of ongoing HBV transmission. We ranked the 1122 municipalities of Colombia based on the reports of HBV infection in pregnant women per 1000 population. Municipalities with ≥0.3 reports per 1000 persons (equating to the top quartile) were further assessed based on health facility birth rates, coverage with three doses of hepatitis B vaccine (HepB3) and seroprevalence data. Hepatitis B risk was considered to be further increased for municipalities with HepB3 coverage or health facility birth rate <90%. In the second phase, we conducted a multistage household serosurvey of children aged 5-10 years in 36 municipalities with the highest assessed HBV risk. HBsAg was not detected in any of 3203 children tested, yielding a 90% upper confidence bound of <0.1% prevalence. Coverage with HepB3 and hepatitis B birth dose was high at 97.5% and 95.6%, respectively. These results support the conclusion that Colombia has likely achieved EMTCT of HBV.

Evaluation of a personalized, dose-sparing revaccination strategy in hepatitis B vaccine non-responders.

OBJECTIVES: The detection of low levels of antibodies against HBsAg (anti-HBs) below 10 IU/L in non-responders after a primary hepatitis B vaccination, is associated with seroconversion after revaccination. We compared the diagnostic performance of four anti-HBs assays in non-responders in their ability to differentiate between absence or presence of low levels of anti-HBs and propose a revaccination strategy guided by anti-HBs titres. METHODS: Non-responders were revaccinated with Fendrix 20 µg at 0, 1 and 2 months. Anti-HBs titres were determined by Abbott Architect, Diasorin Liaison, Roche Cobas and Siemens ADVIA Centaur. Inter-assay agreement was evaluated with Cohen's Kappa (k) in baseline samples between zero-responders without detectable antibodies and poor-responders with detectable antibodies < 10 IU/L. Seroconversion rates and geometric mean titres were analysed at 0, 1 and 3 months. A titre-based strategy (one revaccination dose and anti-HBs measurement followed by two more revaccination doses if required) was compared with the standard revaccination series of 3 doses. RESULTS: 57 participants were included in the analysis. k was ≥ 0.65 for all assays except ADVIA (k ≤ 0.41). After one revaccination dose all assays detected a mean seroconversion rate in zero-responders of 42.9%, compared to 85.1% in poor-responders. The difference between zero- and poor-responders in seroconversion rate per assay was significant (p < 0.05). After three revaccination doses the mean seroconversion rate was 88.2% in zero-responders and 98.5% in poor-responders (p > 0.286 per assay). A titre-based strategy reduced the amount of revaccinations by 17% compared with the standard. CONCLUSIONS: All assays demonstrated a comparable difference in seroconversion rate between zero- and poor-responders after one revaccination dose. The revaccination strategy could be optimised by differentiation between zero- and poor-responders followed by a titre-guided schedule.

Coverage, inequity and predictors of hepatitis B birth vaccination in Myanmar from 2011-2016: results from a national survey.

BACKGROUND: Hepatitis B virus birth dose (HepB-BD) vaccination is recommended to reduce mother to infant transmission. We evaluated the HepB-BD status of women who gave birth between 2011 and 2016 (N = 3,583) using the 2015-2016 Myanmar Demographic and Health Survey. METHODS: Frequency distributions of HepB-BD vaccination across maternal and health system factors, concentration indices, and logistic regression models were used to estimate coverage, inequity, and factors associated with vaccination. RESULTS: The majority of participants were younger than 30 years of age, lived in rural areas, and were multiparous. Almost all received antenatal care (ANC), but only 43% received recommended ANC services, and 60% gave birth at home. The overall HepB-BD coverage rate was 26%. Vaccination coverage was higher in urban areas and was inequitably concentrated among children of more educated and wealthier women. HepB-BD coverage was also positively associated with receipt of ANC at non-governmental facilities, and delivery at a facility, skilled provider at birth and Cesarean delivery. After adjusting for sociodemographic and health system factors, receipt of the HepB-BD was positively associated with weekly media exposure, receipt of recommended ANC, and Cesarean delivery, and inversely associated with home delivery. CONCLUSIONS: Both socioeconomic and health systems factors influenced suboptimal and inequitable vaccination coverage. Improved access to quality ANC and delivery services may increase HepB-BD coverage although targeted approaches to reach home births are likely required to achieve national goals.

Effects of hepatitis B vaccination on hepatitis B surface antigen in neonates and its change in vivo.

Background: Vaccination is effective to prevent hepatitis B virus (HBV) infection. However, there is still a risk of infection after vaccination. In clinical work, we found that newborns were positive for HBV surface antigen (HBsAg) after vaccination. Objectives: To determine the effect of hepatitis B vaccination on the detection of HBsAg trend in newborns. Methods: We collected data at birth, history of vaccination for hepatitis B, quantitative HBsAg results, and other information about newborns born in our hospital from July 2017 to July 2020. Serum samples from healthy neonates were randomly selected to be supplemented with recombinant hepatitis B vaccine on a concentration gradient, and HBsAg was measured quantitatively. Results: Data from 1417 neonates were included in the study; 306 (21.6%) were HBsAg positive within 8 d after vaccination, with levels ranging from 0.104 IU/mL to 0.339 IU/mL. The proportion of neonates with HBsAg-positive serum was significantly correlated with the level of hepatitis B surface antibodies (anti-HBs) in the serum of their mothers (P < 0.01). Experiments in vitro showed that the proportion of neonates with HBsAg-positive serum was correlated with the dose of the hepatitis B vaccine, and when the concentration of the hepatitis B vaccine reached 5 ng/mL and 10 ng/mL, the serum HBsAg levels showed a significant negative correlation with the original concentration of serum anti-HBs. Conclusions: Hepatitis B vaccination can affect the level of HBsAg detected in neonatal serum, and the effect could be mitigated by delaying the measurement. Moreover, maternal anti-HBs offset the effects of neonatal vaccination on HBsAg serum levels.

Seroprevalence of hepatitis B, C and D markers in indigenous patients seen at the Native American Outpatient Clinic of Universidade Federal de São Paulo

ABSTRACT Objective To detect and treat cases of viral hepatitis B, C and D in patients seen at the Native American Outpatient Clinic of Universidade Federal de São Paulo. Methods This sample comprised 81 indigenous recruited between 2018 and 2020. Volunteers were aged 7 months to 70 years (mean age of 28±20 years), belonged to 26 ethnic groups spanning the Brazilian territory and answered a questionnaire, which was attached to their medical records. Peripheral blood samples (20mL) were collected, transported to the Clinical Laboratory of Hospital Israelita Albert Einstein, processed, and tested for markers of viral hepatitis B, C and D. Results In this study, 39 (48.1%) individuals were anti-HBs (+) only, 13 (16.0%) individuals were anti-HBs (+) and anti-HBc (+), and 28 (34.6%) individuals were negative for all markers. No anti-HBc IgM+ samples were found. No cases of hepatitis C and D were found. Conclusion This analysis provided evidence of previous infection by the hepatitis B virus. These findings led to prescription of vaccination against hepatitis B to all participants who were negative for all viral hepatitis B markers, given records of prior hepatitis B vaccination were unreliable.

El HeberNasvac®, una opción en el tratamiento de la hepatitis B crónica

Introducción: En Cuba se produce la vacuna HeberNasvac® para el tratamiento de la hepatitis B crónica. Su relevancia radica en lograr resultados de control virológico sostenido en una mayor proporción de pacientes. Objetivo: Evaluar seguridad y efectividad de la vacuna terapéutica HeberNasvac® en el tratamiento de la hepatitis B crónica, en la provincia Camagüey en el periodo comprendido de enero de 2019 a diciembre de 2020. Métodos: Se realizó un estudio cuasi experimental de intervención terapéutica, en pacientes atendidos en la Consulta Provincial de hepatitis virales crónicas. El universo estuvo constituido por 24 pacientes adultos, con carga viral detectable al inicio del estudio. La fuente primaria de la investigación estuvo dada por la historia clínica. Resultados: En el primer ciclo fueron más frecuentes la cefalea y los estornudos; y en el segundo ciclo la fiebre y el malestar general. Al concluir el tratamiento la mayoría mostraron mejoría de resultados de las pruebas de función hepática. Antes del tratamiento el mayor número de pacientes presentó una carga viral detectable por encima de 250 copias/mL y después de haber recibido tratamiento varios de los casos resultaron carga no detectable. El tratamiento se consideró con mediana seguridad en el mayor número de pacientes y la efectividad fue alta. Conclusiones: Se presentaron más eventos adversos en el segundo ciclo del tratamiento. Las pruebas de función hepática mostraron mejoría al concluir tratamiento. La carga viral después del tratamiento presentó un descenso. El tratamiento mostró mediana seguridad y efectividad alta.

Introduction: Cuba produces the HeberNasvac® vaccine for the treatment of chronic hepatitis B. Its relevance lies in achieving sustained virological control results in a greater proportion of patients. Objective: To evaluate the safety and effectiveness of the therapeutic vaccine HeberNasvac® in the treatment of chronic hepatitis B, in the province of Camagüey in the period from January 2019 to December 2020. Methods: A quasi-experimental study of therapeutic intervention was carried out in patients treated at the Provincial Consultation of Chronic Viral Hepatitis. The universe consisted of 24 adult patients, with detectable viral load at the beginning of the study. The primary source of the investigation was given by the medical history. Results: In the first cycle, headache and sneezing were more prevalent; and in the second cycle, fever and general malaise were more prevalent. At the end of the treatment, the majority showed improvement in the results of liver function tests. Before treatment, the largest number of patients had a detectable viral load above 250 copies / mL and after receiving treatment, several of the cases resulted in an undetectable load. The treatment was considered to be of medium safety in the largest number of patients and the effectiveness was high. Conclusions: There were more adverse events in the second cycle of treatment. Liver function tests showed improvement at the end of treatment. The viral load after treatment showed a decrease. The treatment showed medium safety and high effectiveness.

Building the evidence for hepatitis B vaccination programs for students and researchers working with biological samples in Indian Institutes of Higher Education.

BACKGROUND: Individuals working with biological samples in Indian universities are at risk for occupational exposure to hepatitis B virus (HBV) and may not be vaccinated. AIM: We documented the need for HBV vaccination in students and others, developed an institutional HBV vaccination program, delivered HBV vaccines, and then assessed the determinants of vaccine uptake. METHODS: Over a year, we conducted a prospective cohort study documenting the need for HBV vaccination in people working with biological materials in a major Indian institution, developed a HBV vaccination program, delivered HBV vaccines, and assessed determinants of vaccine uptake. In August 2018, a needs assessment determined exposure to blood, body fluids, and other potentially infectious material in the research setting, followed in September by a cross-sectional survey on HBV vaccination status. Institutional approval for vaccination followed in October, and vaccine clinics began in February 2019. In September, a follow-up survey investigated determinants of vaccine uptake. RESULTS: A total of 185 people participated in the baseline HBV vaccination status survey. Only 26% of students, staff, and faculty were fully vaccinated for HBV. Over 70% of the target group came forward for vaccination and >90% completed all doses. Getting vaccinated with peers strongly influenced vaccine uptake, as did availability of free vaccine, onsite clinics, and reminders. CONCLUSION: HBV vaccination programs for individuals at occupational risk are needed in Indian academic institutions beyond medical schools as part of institutional biosafety programs.

12 Months Persistent Immunogenicity after Hepatitis B Vaccination in Patients with Type 2 Diabetes and Immunogenicity of Revaccination in Non-Responders: An Open-Label Randomized Controlled Trial.

BACKGROUND: In initial studies, the immunogenicity and safety of hepatitis B vaccines in patients with diabetes has been assessed in China. METHODS: In six township health centers in Gansu Province, 232 diabetic patients and 77 healthy people were allocated to receive two 3-dose hepatitis B vaccines (Group D20SC 0-1-6; Group D20CHO 0-1-6; Group ND20SC 0-1-6). Participants were followed up at 12 months after being fully vaccinated. One dose of the vaccine was randomly administered to non-responders. Chi-square test was used to compare the differences in response rate between two groups. RESULTS: The anti-HBs response rates of three groups decreased from 84.1%, 89.1% and 88.3% at one month to 64.6%, 79.8% and 71.4% at twelve months. There was no statistical difference in the immune response rates between Group D20SC 0-1-6 and Group ND20SC 0-1-6; however, that of Group D20CHO 0-1-6 was higher than that of Group D20SC 0-1-6. After revaccination, the geometric mean concentrations were 491.7 mIU/mL and 29.7 mIU/mL after using vaccines containing 60 µg and 20 µg HBsAg. CONCLUSIONS: At 12 months, immune response in diabetic patients were not significantly different from that in healthy people. Revaccination with one dose of hepatitis B vaccine containing 60 µg HBsAg for non-responders was more satisfactory.

Adherence and Effectiveness of HBV Vaccination among Healthcare Workers in Egypt.

CONTEXT: Healthcare workers (HCWs) face a potential risk of acquiring different bloodborne pathogens, by occupational exposure to contaminated blood and body fluids. Hepatitis B vaccine is a safe, effective method of conferring long-term protection against HBV infection. AIMS: The study aimed to assess the adherence and effectiveness of HBV vaccination among HCWs at Gastrointestinal Surgical Center, Mansoura University, Egypt. SETTINGS AND DESIGN: A prospective descriptive study was carried out between June 2019 and December 2019 at Gastrointestinal Surgical Center, Mansoura University, Egypt. METHODS AND MATERIAL: All HCWs with anti-HBs levels below 10 mIU/mL were advised to receive 3 doses of recombinant HBV vaccine, at 0, 1, and 6 months. The anti-HBs levels were checked 3 months after the third dose of the HBV vaccine. STATISTICAL ANALYSIS USED: Data was analyzed using the Statistical Package of Social Science (SPSS) program for windows (version 16). RESULTS: A total of 442 healthcare providers were included. Most of them completed the 3 doses of the vaccine (81.7%), 10.2% refused the vaccine, while 0.9% and 7.2% received 1 and 2 doses, respectively. Odds of vaccination were the highest (88.1%, 273/310) among nurses (OR, 4.7; 95% CI, 2.6-5.2; P ≤ 0.001). The overall anti-HBs positivity of 97% (350/361) was observed. The main reasons for not being vaccinated included the fear of vaccine side effects 25/81 (30.9%) and lack of trust in the vaccine effectiveness 18/81 (22.2%). CONCLUSIONS: The outcome of the present study emphasizes the need to apply alternative and innovative measures to build a positive attitude toward the HBV vaccine among HCWs.

Impact of body mass index on immunogenicity of hepatitis B vaccine in bariatric surgery candidates: A retrospective study.

AIMS: Hepatitis B virus (HBV) immunization is regarded as the most effective method for the prevention of HBV infection. Various factors, including body mass index (BMI), may contribute to decreased immunization responses. This study aimed to investigate the relationship between BMI at the time of vaccination with anti-HBs levels over the following years. METHODS: In this retrospective study, 790 vaccinated participants were recruited. Of these, individuals were selected whose hepatitis B antibody (HBsAb) information was available in 2017. The researchers contacted participants by phone to gather data regarding vaccination history, and weight at the time of vaccination. All data analysis was performed by SPSS. RESULTS: This study included 165 eligible adults (28 males and 137 females). Among them, 79% participants were obese. Additionally, 46 (27.88%) and 119 (72.12%) had negative and positive HBsAb, respectively. There were no statistically significant differences seen across all characteristics, except for the number of HBV vaccinations between the positive and negative HBsAb groups. Multiple logistic regression also indicated no meaningful relationship between BMI and positive antibodies. CONCLUSION: There was no relationship observed between BMI and immune response to HBV vaccine in bariatric candidates. Known risk factors (age, sex, diabetes, and the number of HBV vaccinations) were not independent predictors of the antibody response to the HBV vaccine.