Hepatitis B virus-induced hepatocellular carcinoma: a persistent global problem.

Hepatitis B virus (HBV) infections are highly prevalent globally, representing a serious public health problem. The diverse modes of transmission and the burden of the chronic carrier population pose challenges to the effective management of HBV. Vaccination is the most effective preventive measure available in the current scenario. Still, HBV is one of the significant health issues in various parts of the globe due to non-response to vaccines, the high number of concealed carriers, and the lack of access and awareness. Universal vaccination programs must be scaled up in neonates, especially in the developing parts of the world, to prevent new HBV infections. Novel treatments like combinational therapy, gene silencing, and new antivirals must be available for effective management. The prolonged infection of HBV, direct and indirect, can promote the growth of hepatocellular carcinoma (HCC). The present review emphasizes the problems and probable solutions for better managing HBV infections, causal risk factors of HCC, and mechanisms of HCC.

Estandarización de un método para la identificación y determinación de contenido antigénico en vacunas contra la hepatitis B mediante el ensayo por inmunoabsorción ligado a enzima (ELISA) / Standardization of identification and determination of antigenic content in hepatitis B vaccines enzyme linked immuno sorbent assay (ELISA) method

Las afecciones causadas por el Virus de la Hepatitis B (VHB) constituyen una de las grandes problemáticas de salud pública a nivel mundial. En la actualidad la principal estrategia de prevención es una vacuna obtenida mediante la tecnología de ADN recombinante a partir de la expresión del gen viral que codifica el antígeno de superficie de la hepatitis B (HBsAg). En Argentina, esta vacuna está incorporada en el Calendario Nacional de Vacunación desde el año 2000, y es deber de la Autoridad Reguladora Nacional (ARN) verificar la calidad, seguridad y eficacia de cada lote liberado al mercado. Considerando que la determinación del contenido antigénico en vacunas representa uno de los ensayos esenciales de control de calidad y que, para ello, es necesario contar con metodologías estandarizadas que permitan obtener resultados reproducibles y confiables, en el Laboratorio de Inmunobiológicos del Instituto Nacional de Medicamentos se estandarizó un método para la identificación y cuantificación del HBsAg en vacunas contra la Hepatitis B empleando un kit comercial de ELISA cuyo uso clínico está previsto para la detección de HBsAg en suero o plasma humano. Para ello, se analizaron dos muestras: una preparación de antígeno HBsAg purificado y una vacuna contra la Hepatitis B ADN recombinante comercial y se evaluaron los parámetros de especificidad, exactitud, repetibilidad, precisión intermedia y linealidad. En todos los casos, se cumplieron con los criterios de aceptación establecidos para cada parámetro, por lo cual se concluye que la metodología analítica es adecuada para la identificación y cuantificación del HBsAg.

Estandarización de un método para la identificación y determinación de contenido antigénico en vacunas contra la hepatitis B mediante el ensayo por inmunoabsorción ligado a enzima (ELISA) / Standardization of identification and determination of antigenic content in hepatitis B vaccines enzyme linked immuno sorbent assay (ELISA) method

Las afecciones causadas por el Virus de la Hepatitis B (VHB) constituyen una de las grandes problemáticas de salud pública a nivel mundial. En la actualidad la principal estrategia de prevención es una vacuna obtenida mediante la tecnología de ADN recombinante a partir de la expresión del gen viral que codifica el antígeno de superficie de la hepatitis B (HBsAg). En Argentina, esta vacuna está incorporada en el Calendario Nacional de Vacunación desde el año 2000, y es deber de la Autoridad Reguladora Nacional (ARN) verificar la calidad, seguridad y eficacia de cada lote liberado al mercado. Considerando que la determinación del contenido antigénico en vacunas representa uno de los ensayos esenciales de control de calidad y que, para ello, es necesario contar con metodologías estandarizadas que permitan obtener resultados reproducibles y confiables, en el Laboratorio de Inmunobiológicos del Instituto Nacional de Medicamentos se estandarizó un método para la identificación y cuantificación del HBsAg en vacunas contra la Hepatitis B empleando un kit comercial de ELISA cuyo uso clínico está previsto para la detección de HBsAg en suero o plasma humano. Para ello, se analizaron dos muestras: una preparación de antígeno HBsAg purificado y una vacuna contra la Hepatitis B ADN recombinante comercial y se evaluaron los parámetros de especificidad, exactitud, repetibilidad, precisión intermedia y linealidad. En todos los casos, se cumplieron con los criterios de aceptación establecidos para cada parámetro, por lo cual se concluye que la metodología analítica es adecuada para la identificación y cuantificación del HBsAg.

Estandarización de un método para la identificación y determinación de contenido antigénico en vacunas contra la hepatitis B mediante el ensayo por inmunoabsorción ligado a enzima (ELISA) / Standardization of identification and determination of antigenic content in hepatitis B vaccines enzyme linked immuno sorbent assay (ELISA) method

Las afecciones causadas por el Virus de la Hepatitis B (VHB) constituyen una de las grandes problemáticas de salud pública a nivel mundial. En la actualidad la principal estrategia de prevención es una vacuna obtenida mediante la tecnología de ADN recombinante a partir de la expresión del gen viral que codifica el antígeno de superficie de la hepatitis B (HBsAg). En Argentina, esta vacuna está incorporada en el Calendario Nacional de Vacunación desde el año 2000, y es deber de la Autoridad Reguladora Nacional (ARN) verificar la calidad, seguridad y eficacia de cada lote liberado al mercado. Considerando que la determinación del contenido antigénico en vacunas representa uno de los ensayos esenciales de control de calidad y que, para ello, es necesario contar con metodologías estandarizadas que permitan obtener resultados reproducibles y confiables, en el Laboratorio de Inmunobiológicos del Instituto Nacional de Medicamentos se estandarizó un método para la identificación y cuantificación del HBsAg en vacunas contra la Hepatitis B empleando un kit comercial de ELISA cuyo uso clínico está previsto para la detección de HBsAg en suero o plasma humano. Para ello, se analizaron dos muestras: una preparación de antígeno HBsAg purificado y una vacuna contra la Hepatitis B ADN recombinante comercial y se evaluaron los parámetros de especificidad, exactitud, repetibilidad, precisión intermedia y linealidad. En todos los casos, se cumplieron con los criterios de aceptación establecidos para cada parámetro, por lo cual se concluye que la metodología analítica es adecuada para la identificación y cuantificación del HBsAg.

The Association Between Hla-B40, Hla-Dqa1*01 and Hla-Dqb1*05 Alleles and Antibody Response to Hepatitis B Vaccination in Turquish Hemodislysis Patients / Asociación entre los Alelos Hla-B40, Hla-Dqa1*01 y Hla-Dqb1*05 y Respuesta de Anticuerpos a la Vacuna contra la Hepatitis B en Pacientes Turcos en Hemodiálisis

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.

Hepatitis B Immunization Analysis: Tracking of Antibody Levels among Dental Patients.

AIM: To verify the immunization status of dental students against HBV using an immunochromatographic rapid test and explore its associated protective and preventive effects against the disease. MATERIAL AND METHODS: This transversal epidemiological study was conducted in a public dental school in Brazil. A total of 263 dental students who were at clinical practice were invited to participate in the study. A semi-structured questionnaire that investigated the issues related to the theme was created for data collection. An immunochromatographic test for the detection of anti-Hepatitis B surface antigen was used to verify the immunization status. Data were analyzed using the Statistical Package for the Social Sciences (SPSS). RESULTS: Approximately 59.2% of the participants did not know the etiological agent of hepatitis B infection, and 36.6% did not know the number of doses of hepatitis B vaccines. Further-more, 53.2% of the participants were immunized against HBV. Logistic regression showed that those who received less than three doses of the vaccine (OR = 2.539) or did not know how many doses they received (OR = 3.022) had higher risks of not developing the immunity. Moreover, age (OR = 0.834) was a protective factor against non-immunization. CONCLUSION: There was a low prevalence of dental students who were immunized against HBV. The number of vaccine doses received and the participants' age had significant associations with the immunization status. CLINICAL SIGNIFICANCE: Deals with an issue of major impact on the public health because of the high rates of hepatitis B in the general population, as well as the lack of knowledge of the subject by a large part of dental surgeons and dental students.

[Inappropriate response against Hepatitis B vaccine in health personnel of the National Hospital, Paraguay.] / Respuesta inadecuada a la vacuna contra la hepatitis B en personal de salud del Hospital Nacional, Paraguay.

Introduction: health personnel are a risk group for acquiring hepatitis B. The vaccine against it is effective but requires evaluation of the immune response with the dosage of anti-HBs. Objective: Objectives: to determine the immunological response to the vaccine against hepatitis B in physicians, nurses and medical students of the National Hospital, Paraguay. Methods: an observational, analytical and cross-sectional study was conducted in a sample of 120 health workers during 2017. The level of anti-HBs was determined with quantitative immunoassay and demographic and clinical variables were recorded, with prior informed consent. Results: the sample was integrated with 79 women and 41 men. The mean age was 28±7 years. Physicians (62.5%), nurses (20%) and medical students (17.5%) were included. The mean BMI was 24.7 ± 3.8 kg/m2. Adequate serum levels of anti-HBs (> 100 IU / mL) were detected in 64% of the health personnel. Obesity was a factor associated with poor response to the vaccine (p 0.02). Sex, age, the time elapsed since the last dose and smoking were factors not significantly associated with the lack of response to the vaccine. Conclusion: inadequate response to HB vaccine was found in 36%. Obesity was significantly associated with poor immunological response.

Introducción: el personal de salud es un grupo de riesgo de adquirir la hepatitis B. La vacuna contra la misma es efectiva pero requiere evaluación de la respuesta inmune con el dosaje de antiHBs. Objetivos: determinar la respuesta inmunológica a la vacuna contra la hepatitis B en médicos, enfermeras y estudiantes de Medicina del Hospital Nacional, Paraguay. Métodos: se realizó un estudio observacional, analítico y transversal en una muestra de 120 trabajadores de la salud durante el 2017. Se determinó el nivel de antiHBs con inmunoensayo cuantitativo y se registraron variables demográficas y clínicas, previo consentimiento informado. Resultados: Resultados: la muestra se conformó con 79 mujeres y 41 varones. La edad media fue 30±8 años. Se incluyeron médicos (62,5%), enfermeras (20%) y estudiantes de Medicina (17,5%). El IMC medio fue 24,7±3,8 kg/m2. Los niveles séricos adecuados de antiHBs (>100 UI/mL) se detectaron en 64% del personal de salud. La obesidad fue un factor asociado a mala respuesta a la vacuna (p 0,02). El sexo, la edad, el tiempo trascurrido desde la última dosis y el tabaquismo no resultaron factores significativamente asociados a la falta de respuesta a la vacuna. Conclusión: la respuesta inadecuada a vacuna HB se halló en 36%. La obesidad se asoció significativamente a la mala respuesta inmunológica.

Long-term protection after hepatitis B vaccination in people living with HIV.

BACKGROUND: Hepatitis B vaccine is important in people living with HIV (PLHIV) since both viruses have the same transmission routes and co-infection has greater morbidity. PLHIV usually have poor response to hepatitis B vaccine. The duration of immunity in PLHIV is unknown. The objective of this study is to evaluate the duration of serological response and clinical protection provided by hepatitis B vaccination in PLHIV. METHODS: Retrospective study of a PLHIV cohort primarily vaccinated for hepatitis B virus (HBV) from 2001 to 2002. Markers of infection and protection from HBV were investigated in those individuals who were still attending the outpatient clinic, in São Paulo, Brazil from 2012 to 2014. Three groups were analyzed. Group 1: adults who responded to primary vaccine series. Group 2: non-responders to primary vaccine series. Group 3: subjects from both Groups 1 and 2 who did not receive any booster doses after seroconversion. RESULTS: A cohort of 121 PLHIV was analyzed for seroconversion and persistence of anti-HBs. The majority were female (54.5%) and mean age was 50.1years. After 11years, none of the patients had serologic evidence of HBV infection. Overall, 41/58 (70.7%) of the initial responders (Group 1) had maintained anti-HBs≥10mIU/mL. Greater CD4+ values and anti-HBs>100mIU/mL at the time of first vaccine series were associated with persistence of anti-HBs. During the time of evaluation, 35/63 (55.6%) of the initial non-responders (Group 2) successfully seroconverted (anti-HBs≥10mIU/mL) in response to one or more booster doses. From the time of their seroconversion, 70 of the patients did not receive any further booster doses (Group 3). After 10years, 54/70 (77.1%) of these individuals has maintained anti-HBs≥10mIU/mL. CONCLUSIONS: Evaluation of long-term immunity for hepatitis B in PLHIV following vaccination showed a strong persistence of anti-HBs and no serologic evidence of HBV infection. Boosters may be effective in PLHIV non-responders to primary vaccination.

Low prevalence, low immunization and low adherence to full hepatitis B vaccine scheme and high-risk behaviors among crack cocaine users in central Brazil.

Crack cocaine users represent a target group for hepatitis B vaccination. We evaluate the HBV epidemiology, immunization status and compliance with a super-accelerated vaccination schedule among in-treatment crack cocaine users in central Brazil. Six hundred in-treatment crack cocaine users were interviewed, and serum samples were tested for HBV markers. A super-accelerated vaccination schedule of HBV vaccine was offered to all susceptible crack cocaine users. In total, 7.0% of those tested had at least one positive marker of HBV exposure. Age, use of crack cocaine through improvised pipe, exchange of sex for money/drugs and previous sexually transmitted infections (STIs) were predictors of HBV exposure. One hundred six (17.7%) individuals showed a serological profile of hepatitis B vaccination. Of these, 54.7% were less than 25 years old, and only 13% of individuals were more than 35 years old. Although 91.8% of crack users accepted the first vaccine dose, only 21.7% received all three doses. Of the 23 crack cocaine users who agreed to have their vaccine response evaluated, 78.3% developed protective anti-HBs titers. Premature termination of treatment was the most common reason for not receiving the full vaccine series. Despite the low prevalence of HBV exposure among in-treatment crack cocaine users in central Brazil, the low rate of immunization and the high frequency of high-risk behaviors highlight the potential for crack users to acquire and disseminate this infection and therefore maintain the viral reservoir. Health practitioners need to keep this in mind, taking advantage of all opportunities to access this population and vaccinate against HBV.

Respuesta a la vacuna contra la hepatitis B en pacientes en hemodiálisis crónica

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.

Hepatitis B monovalent vaccines produced by different manufacturers: comparative study on the quality of vaccine in period before and after the shelf life / Vacinas de Hepatite B monovalente produzidas por diferentes fabricantes: estudo comparativo da qualidade das vacinas no período pré e após o prazo de validade

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.

Hepatitis B monovalent vaccines produced by different manufacturers: comparative study on the quality of vaccine in period before and after the shelf life / Vacinas de Hepatite B monovalente produzidas por diferentes fabricantes: estudo comparativo da qualidade das vacinas no período pré e após o prazo de validade

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(AU)

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(AU)

Seroprevalence of hepatitis B in two period birth cohorts of Bolivian children: effect of universal vaccination.

BACKGROUND: Since 2000 universal routine immunization against the hepatitis B virus (HBV) was implemented in Bolivia. This study aimed to assess the seroprevalence of markers against HBV in two different birth cohorts (pre-universal vaccine cohort and post-universal vaccine cohort) from Cochabamba, Bolivia. METHODS: We performed a school-based seroepidemiological survey (n = 424) of HBV in 2010 in the Cochabamba region. An ELISA test was used to measure antibodies to the hepatitis B surface antigen (anti-HBs IgG) and to the hepatitis B core antigen (anti-HBc IgG). RESULTS: The prevalence of anti-HBs IgG in the pre-universal vaccine cohort was 5.8% (95% CI: 3.3-8.3%); it was higher in boys (9.1%), and those living in suburbs (9.7%). The anti-HBs IgG prevalence among post-universal vaccine cohort was 37.9% (95% CI: 28.5-48.1%), and was higher in children who spoke Quechua at home (51.0%), those living in suburbs (53.9%), and those born in 2005 (72.7%). Neither cohort showed differences relating to parental education. The prevalence of anti-HBc IgG was 1.1% among post-universal vaccine cohort and 1.2% among pre-universal vaccine cohort (p > 0.05). CONCLUSIONS: This study identified a persistent low seroprevalence of hepatitis B infection in spite of a decade of universal immunization, and low long-term humoral immunity against HBV infection in vaccinated children in Cochabamba. 

Brazilian hepatitis B vaccine: a six-year follow-up in adolescents

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.

Presence of maternal anti-HBs antibodies does not influence hepatitis B vaccine response in Brazilian neonates

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.

Análise de fatores associados à não aceitação da vacina contra hepatite B em adolescentes escolares de baixa renda / Analysis of factors associated with non-acceptance of hepatitis B vaccine among low income adolescent students

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.