Preparation and evaluation of formalized bivalent Newcastle and Salmonella poultry vaccine

This study was conducted to prepare and evaluate the potency of different inactivated vaccine formulations that protect chickens against Salmonella Enteritidis and Newcastle disease virus using Montanide as adjuvant. Protection and the humoral immune response of prepared vaccines against Salmonella Enteritidis and Newcastle disease virus was evaluated and compared to imported vaccine. In this study, different formulae of Salmonella Enteritidis and Newcastle disease vaccines were prepared and compared with the imported one by measuring the antibody titer against Newcastle disease virus by hemagglutination inhibition test and the antibody titer against Salmonella Enteritidis using Enzyme Linked Immunosorbent Assay. On the other hand, the protection percentages against Newcastle disease and Salmonella Enteritidis were recorded to determine the best effective formula. The highest hemagglutination inhibition antibody level against NDV at first week was recorded for the prepared combined Newcastle disease and Salmonella Enteritidis vaccine (4.2 log2) followed by the prepared monovalent Newcastle disease (3.4 log2); the lowest antibody level (3.1 log2) was obtained with the imported vaccine. A gradual increase was observed in all groups to 7.1 log2, 6.8 log2 and 6.4 log2 at fourth week post vaccination, respectively. The antibody titer against Salmonella Enteritidis was 552 for the prepared combined Salmonella Enteritidis and Newcastle disease, followed by the prepared monovalent Salmonella Enteritidis (477) at first week post vaccination; the antibody titer obtained for the imported vaccine was 477. There was a gradual increase to 1456, 1406 and 1130 at fourth week post vaccination, respectively. Prepared combined vaccines gave the highest protection percentage, followed by prepared monovalent types and finally imported vaccines. Vaccination by the prepared combined Salmonella Enteritidis and Newcastle disease vaccine may be a way to increase the resistance of birds to Salmonella and Newcastle and to decrease the shedding rate(AU)

Este estudio se llevó a cabo para preparar y evaluar la potencia de diferentes formulaciones de vacunas inactivadas que protegen a los pollos contra Salmonella Enteritidis y el virus de la enfermedad de Newcastle utilizando Montanide como adyuvante. Se evaluó la protección y la respuesta inmune humoral de las vacunas preparadas contra Salmonella Enteritidis y el virus de la enfermedad de Newcastle y se comparó con la vacuna importada. En este estudio se prepararon diferentes fórmulas de vacunas contra Salmonella Enteritidis y la enfermedad de Newcastle y se compararon con la importada midiendo el título de anticuerpos contra el virus de la enfermedad de Newcastle mediante la prueba de inhibición de la hemaglutinación y el título de anticuerpos contra Salmonella Enteritidis mediante ELISA. Por otra parte, se registraron los porcentajes de protección contra la enfermedad de Newcastle y Salmonella Enteritidis para determinar la fórmula más eficaz. El mayor nivel de anticuerpos inhibidores de la hemaglutinación contra el virus de la enfermedad de Newcastle, en la primera semana, se registró con la vacuna combinada preparada contra la enfermedad de Newcastle y Salmonella Enteritidis (4,2 log2), seguida de la vacuna monovalente preparada contra la enfermedad de Newcastle (3,4 log2); el menor nivel de anticuerpos (3,1 log2) se obtuvo con la vacuna importada. Se observó un aumento gradual en todos los grupos hasta alcanzar 7,1 log2, 6,8 log2 y 6,4 log2 en la cuarta semana tras la vacunación, respectivamente. El título de anticuerpos contra Salmonella Enteritidis fue de 552 para la vacuna combinada preparada contra la Salmonella Enteritidis y enfermedad de Newcastle, seguida por la vacuna monovalente preparada contra Salmonella Enteritidis (477) en la primera semana después de la vacunación; el título de anticuerpos obtenido con la vacuna importada fue de 477. Hubo un aumento gradual hasta 1456, 1406 y 1130 en la cuarta semana después de la vacunación, respectivamente. Las vacunas combinadas preparadas dieron el mayor porcentaje de protección, seguidas por los tipos monovalentes preparados y, por último, por las vacunas importadas. La vacunación con la vacuna combinada preparada contra la Salmonella Enteritidis y la enfermedad de Newcastle puede ser una forma de aumentar la resistencia de las aves a la Salmonella y Newcastle y de disminuir la tasa de excreción(AU)

Recommendations for modernizing infant vaccination schedules with combination vaccines in Colombia and Peru / Recomendaciones para modernizar los calendarios de vacunación infantil con vacunas combinadas en Colombia y Perú / Recomendações para modernizar os esquemas de vacinação infantil com vacinas combinadas na Colômbia e no Peru

ABSTRACT The objective of this article was to consider the vaccination challenges in Colombia and Peru and the role of pediatric combination vaccines in overcoming these challenges. Barriers to including new vaccines with more antigens remain apparent in parts of these countries, where vaccine-preventable diseases in infants continue to be a major problem. The challenges include the heterogeneity of vaccine coverage within each country and in neighboring countries, which can contribute to poor rates of vaccination coverage; the adverse impact of the inward migration of unvaccinated individuals, which has favored the re-emergence of vaccine-preventable diseases; vaccine shortages; and the impact of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and the associated shifts in health care resources. To improve the coverage of pediatric vaccines in Colombia and Peru, it will be necessary to ensure the widespread integration into vaccine schedules of combination vaccines containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b and hepatitis B antigens with a three-dose primary series delivered at 2, 4 and 6 months of age followed by a booster at 18 months of age. Such vaccines play important roles in preventing diphtheria, tetanus and pertussis; eradicating polio; and providing boosting against H. influenzae type b.

RESUMEN El objetivo de este artículo es considerar los desafíos que se enfrentan en Colombia y Perú con respecto a la vacunación y el papel de las vacunas combinadas pediátricas para superar estos desafíos. Los obstáculos para incluir vacunas nuevas con más antígenos siguen siendo evidentes en algunos lugares de estos países, donde las enfermedades prevenibles por vacunación en menores de 1 año continúan siendo un grave problema. Entre los desafíos se incluye la heterogeneidad de la cobertura de vacunación en cada país y en los países vecinos, lo que puede contribuir con que se registren tasas bajas de cobertura de vacunación; el impacto adverso de la migración interna de personas no vacunadas, lo que ha favorecido la reaparición de enfermedades prevenibles por vacunación; la escasez de vacunas, y el impacto de la pandemia del coronavirus de tipo 2 causante del síndrome respiratorio agudo grave (SARS-CoV-2) y los consiguientes cambios en los recursos de atención médica. Para mejorar la cobertura de las vacunas pediátricas en Colombia y Perú será necesario integrar de manera generalizada en los calendarios de vacunación vacunas combinadas con antígenos de difteria, tétanos, tos ferina acelular, poliovirus inactivados, Haemophilus influenzae tipo b y hepatitis B con una serie primaria de tres dosis administradas a los 2, 4 y 6 meses de edad, seguida de un refuerzo a los 18 meses de edad. Esas vacunas desempeñan un papel esencial en la prevención de la difteria, el tétanos y la tos ferina; la erradicación de la polio; y el refuerzo contra H. influenzae tipo b.

RESUMO O objetivo deste artigo foi avaliar os desafios da vacinação na Colômbia e no Peru e o papel das vacinas pediátricas combinadas na superação de tais desafios. Os obstáculos para incluir novas vacinas com mais antígenos permanecem visíveis em partes desses países, onde doenças imunopreveníveis em lactentes continuam a ser um grande problema. Os desafios incluem a heterogeneidade da cobertura vacinal dentro de cada país e nos países vizinhos, o que pode contribuir para baixas taxas de cobertura vacinal; o impacto adverso da migração interna de pessoas não vacinadas, o que favoreceu o ressurgimento de doenças imunopreveníveis; a escassez de vacinas; e o impacto da pandemia de síndrome respiratória aguda grave do coronavírus 2 (SARS-CoV-2) e mudanças relacionadas nos recursos de atenção à saúde. Para melhorar a cobertura das vacinas pediátricas na Colômbia e no Peru, será necessário assegurar sua integração generalizada em esquemas de vacinas combinadas contendo antígenos de difteria, tétano, pertussis acelular, poliovírus inativado, Haemophilus influenzae tipo B e hepatite B, com uma série primária de três doses aplicadas aos 2, 4 e 6 meses de idade seguidas de um reforço aos 18 meses de idade. Tais vacinas desempenham papéis importantes na prevenção da difteria, tétano e coqueluche; na erradicação da poliomielite; e no reforço contra H. influenzae tipo b.

Tumor de Buschke ­ Löwenstein: Presentación de un Caso y Revisión Bibliográfica / Buschke ­ Löwenstein Tumor: A Case Report and Review of the Literature

Introducción: El tumor de Buschke ­ Lowenstein (TBL) es enfermedad de transmisión sexual causada por el virus del papiloma humano (VPH), descrita como una forma intermedia entre un condiloma acuminado y un carcinoma de células escamosas. Afecta principalmente al área genital y anorrectal, posee capacidad de transformación maligna y una alta tasa de recurrencia. La cirugía es el tratamiento de primera línea. Caso clínico: Presentamos el caso de un paciente masculino de 27 años con lesiones verrucosas de crecimiento progresivo en el área inguinal y genital. Mediante la correlación clínico-patológica se llegó al diagnóstico de TBL. Tras discusión en comité multidisciplinario se declaró irresecable y se resolvió tratamiento con radioterapia, además vacunación terapéutica contra el VPH, tanto sistémica como intralesional. Conclusión: El TBL es localmente agresivo y de difícil tratamiento, por lo que la prevención contra el VPH es fundamental. La vacunación terapéutica en conjunto con la radioterapia ofreció mejoría clínica.

Introduction: Buschke-Lowenstein tumor (BLT) is a sexually transmitted disease caused by the human papillomavirus (HPV), described as an intermediate form between condyloma acuminata and squamous cell carcinoma. It mainly affects the genital and anorectal areas and has the capacity for malignant transformation and a high recurrence rate. Surgery is the first-line treatment. Clinical case: We present the case of a 27-year-old male patient with warty lesions of progressive growth in the inguinal and genital areas. Through the clinical-pathological correlation, the diagnosis of BLT was reached. After discussion in a multidisciplinary committee, it was declared unresectable, and treatment with radiotherapy was resolved, in addition to therapeutic vaccination against HPV, both systemic and intralesional. Conclusion: BLT is locally aggressive and challenging to treat, so prevention against HPV is essential. Therapeutic vaccination in conjunction with radiotherapy offered clinical improvement.

Atraso na vacina tetravalente (DTP+Hib) em crianças de 12 a 23 meses de idade: Pesquisa Nacional de Saúde, 2013 / Delay in quadrivalent vaccine (DTP+Hib) in children 12 to 23 months of age: Brazilian National Health Survey, 2013 / Retraso en la vacuna tetravalente (DTP+Hib) en niños de 12 a 23 meses de edad: Encuesta Nacional de Salud, 2013

Resumo: O objetivo foi estimar a prevalência do atraso nas três doses da vacina tetravalente (DTP+Hib) em crianças de 12 a 23 meses de idade, no Brasil, por meio dos dados da Pesquisa Nacional de Saúde (PNS) de 2013 e descrever o atraso em cada uma das doses segundo variáveis sociodemográficas, utilização de serviços e intervenções públicas de saúde. Foram utilizados dados da PNS, estudo transversal realizado em 2013. O desfecho foi o atraso pelo menos em uma das três doses da vacina tetravalente. Considerou-se como atraso a dose recebida pelo menos 30 dias após a data preconizada, segundo informação da caderneta de vacinação. A prevalência do atraso foi descrita segundo variáveis sociodemográficas e utilização de serviços de saúde. Realizou-se análise descritiva obtendo-se frequências absolutas e relativas e seus respectivos intervalos de 95% de confiança. Das 2.016 crianças com informações coletadas, 1.843 foram analisadas. A prevalência de atraso de pelo menos uma dose da vacina foi de 44%. Observou-se atraso de 14,8% na primeira, 28,8% na segunda e 45,4% na terceira dose, sendo que 10% das crianças tiveram atraso nas três doses. Maiores prevalências de atraso foram encontradas em crianças do sexo masculino, de cor da pele parda, pertencentes ao quintil mais pobre de riqueza, moradores da zona rural e da Região Norte do Brasil. Evidenciou-se alta prevalência de atraso na vacina tetravalente (DTP+Hib) em crianças de 12 a 23 meses do Brasil, sendo maior na terceira dose.

Abstract: The study aimed to estimate the prevalence of delay in the three doses of quadrivalent vaccine (DTP+Hib) in children 12 to 23 months of age in Brazil, based on data from the Brazilian National Health Survey (PNS) of 2013 and to analyze the delay in each of the doses according to sociodemographic variables and use of health services and public health interventions. The data are from the PNS a cross-sectional study performed in 2013. The outcome was delay in at least one of the three doses of the quadrivalent vaccine. Delay was defined as a dose received at least 30 days after the recommended date according to information on the child's vaccination card. Prevalence of delay was analyzed according to sociodemographic variables and use of health services. A descriptive analysis was performed to obtain absolute and relative frequencies and their respective 95% confidence intervals. Of the 2,016 children with information collected, 1,843 were analyzed. The prevalence of delay in at least one dose of the vaccine was 44%. There was a delay of 14.8% in the first dose, 28.8% in the second, and 45.4% in the third, and 10% of the children had delays in all three doses. Higher prevalence of delay was associated with male gender, brown skin color, the poorest income quintile, and residence in rural areas and the North of Brazil. The study revealed high prevalence of delay with the quadrivalent vaccine (DTP+Hib) in children 12 to 23 months of age in Brazil, with the highest delay in the third dose.

Resumen: El objetivo fue estimar la prevalencia del atraso en las tres dosis de la vacuna tetravalente (DTP+Hib) en niños de 12 a 23 meses de edad, en Brasil, mediante los datos de la Encuesta Nacional de Salud (PNS) de 2013 y describir el retraso en cada una de las dosis, según variables sociodemográficas, utilización de servicios e intervenciones públicas de salud. Se trata de un estudio transversal, realizado en 2013, con datos de la PNS. El resultado fue el retraso por lo menos en una de las tres dosis de la vacuna tetravalente. Se consideró como un atraso la dosis recibida por lo menos 30 días tras la fecha prefijada, según la información de la cartilla de vacunación. La prevalencia del atraso fue descrita según variables sociodemográficas y utilización de servicios de salud. Se realizó un análisis descriptivo, obteniéndose frecuencias absolutas y relativas, así como sus respectivos intervalos de 95% de confianza. De los 2016 niños con información recogida, se analizaron 1843. La prevalencia de atraso de por lo menos una dosis de la vacuna fue de un 44%. Se observó un retraso de 14,8% en la primera, un 28,8% en la segunda y un 45,4% en la tercera dosis, siendo que un 10% de los niños sufrieron atraso en las tres dosis. Las mayores prevalencias de atraso se encontraron en niños de sexo masculino, mestizos, pertenecientes al quintil más pobre de riqueza, habitantes de la zona rural y de la Región Norte de Brasil. Se evidenció una alta prevalencia de atraso en la vacuna tetravalente (DTP+Hib) en niños de 12 a 23 meses de Brasil, siendo mayor en la tercera dosis.

Research progress on immunogenicity evaluation of serogroup B meningococcal vaccine / 中华预防医学杂志

Epidemic cerebrospinal meningitis (meningococcal meningitis) is an acute respiratory infectious disease with high mortality and serious sequelae. Meningococcal vaccine is an effective measure to prevent and control meningococcal meningitis. At present, group B meningococcal meningitis has become the main prevalent serum group in the world, including China. Meningococcal ACYW and other vaccines are mainly composed of capsular polysaccharides, while the main component of group B meningococcal vaccine is protein, including outer membrane vesicles (OMV) and recombinant protein vaccine. The methods for evaluating the immunogenicity of group B meningococcal vaccine include hSBA and alternative methods such as meningococcal antigen typing system (MATS), flow cytometric meningococcal antigen surface expression assay (MEASURE), genetic meningococcal antigen typing system (gMATS) and bexsero antigen sequence type (BAST). The evaluation of vaccine immunogenicity is the basis of vaccine development and clinical trial research, However, at present, there is no group B meningococcal vaccine in China. Therefore, in this paper, the research progress of immunogenicity evaluation of group B meningococcal vaccine has been reviewed, in order to provide technical guidance for the research and development of group B meningococcal vaccine, immunogenicity evaluation and clinical trial research in China.

Impacto de la pandemia por SARS-CoV-2 en la administración de vacunas del Calendario Nacional de Inmunizaciones en menores de 2 años / Impact of the SARS-CoV-2 pandemic on the administration of vaccines as per the national immunization schedule in children younger than 2 years

Introducción. El menor número de consultas a los centros de atención desde el comienzo de la pandemia por SARS-CoV-2podría afectar la vacunación obligatoria.Objetivo. Evaluar el impacto de la pandemia por SARS-CoV-2en la administración de vacunas pentavalente y triple viral a niños menores de 2 años en el vacunatorio de un hospital pediátrico de la Ciudad de Buenos Aires.Método. Estudio transversal, que utilizó registros informatizados del vacunatorio, de enero a mayo de 2019 y 2020.Resultados. Desde la segunda quincena de marzo de 2020, se observó un 64,2 % de disminución en la aplicación de vacunas. Al examinar la primera dosis de pentavalente y triple viral, la reducción fue del 74,9 % y del 55,1 %, respectivamente.Conclusión. A partir de la segunda quincena de marzo de 2020, se observó una disminución del 64,2 % en las vacunas aplicadas respecto del mismo período en el año anterio

Introduction. The reduction in the number of visits to health care centers since the onset of the SARS-CoV-2 pandemic may affect mandatory vaccination.Objective. To assess the impact of the SARS-CoV-2 pandemic on the administration of the pentavalent and the measles, mumps, and rubella (MMR) vaccines to children younger than 2 years at the vaccination center of a children's hospital in the Autonomous City of Buenos Aires.Method. Cross-sectional study using the vaccination center's digital records from January to May 2019 and 2020.Results. In the second fortnight of March 2020, vaccinations dropped by 64.2 %. When examining the first dose of the pentavalent and MMR vaccines, such reduction was 74.9 % and 55.1 %, respectively.Conclusion. As of the second fortnight of March 2020, vaccinations dropped by 64.2 % compared to the same period of the previous year.

Caracterización de la hipotonía-hiporrespuesta post vacuna pentavalente y tamizaje del neurodesarrollo en niños bajo 6 años de edad, 2013-2018, Uruguay / Characterization of hypotonia-hyporesponsiveness after pentavalent vaccine and neurodevelopmental screening in children under 6 years of age, 2013-2018, Uruguay

INTRODUCCIÓN: La hipotonía-hiporrespuesta (HHR) es uno de los efectos adversos supuestamente atribuibles a la vacunación e inmunización de tipo neurológico más notificados. El impacto a largo plazo a nivel del neurodesarrollo no es completamente conocida. OBJETIVO: Caracterizar los eventos de HHR post vacuna pentavalente notificados entre 2014 y 2018 al Ministerio de Salud Pública (MSP) de Uruguay. Realizar el tamizaje del neurodesarrollo de los que al momento de la evaluación tenían menos de 6 años de edad. METODOLOGÍA: Estudio descriptivo de las notificaciones al Sistema Nacional de Farmacovigilancia del MSP. Se realizó el tamizaje del neurodesarrollo con la Guía Nacional para la Vigilancia del Desarrollo. RESULTADOS: 30 casos, la mayoría de breve duración, en las primeras horas post primera dosis y con recuperación espontánea. Requirieron hospitalización 29. Se realizó el tamizaje del neurodesarrollo en 16. La media de tiempo entre el evento y esta evaluación fue 2 años y 2 meses. Fue normal la prueba de tamizaje en 15. En uno se detectó un retraso del lenguaje. CONCLUSIONES: Los episodios de HHR se presentaron con características similares a las descritas en la bibliografía. A pesar de las limitaciones del estudio, no se encontraron retrasos ni desvíos del desarrollo en los niños evaluados.

BACKGROUND: Hypotonic-hyporesponsive episodes (HHE) is one frequently reported neurologic adverse effect supposedly attributable to vaccination and immunization. Its long-term impact on neurodevelopment is not completely known. AIM: To characterize the post-pentavalent vaccine HHE events reported to the Uruguayan Ministry of Health (M of H) between 2014 and 2018. To perform neurodevelopment screening of those who were under 6 years of age at the time of evaluation. METHODS: Descriptive study of the reports made to the National Farmacosurveillance System of the M of H. Neurodevelopment screening was performed using the National Guidelines for Developmental Surveillance. RESULTS: 30 cases were studied. Most cases occurred after the first doses, were of short duration and during the first hours after vaccination, with spontaneous recovery. Median time between the event and this evaluation was 2 years and 2 months. Screening tests were normal in 15. Delay in the language area was detected in one case. CONCLUSIONS: HHE events had similar characteristics to those described in the literature, with no severe short-term complications. Despite the limitations of the present study, no delays nor deviations were found in the development of the children who were evaluated.

Análisis económico de las vacunas del primer año de vida con componente pertussis en el contexto de la ini-ciativa mundial de erradicación de la poliomielitis en Argentina / Vaccination in children under 1 year with pertussis component in the context of the global initiative for the eradication of poliomyelitis in Argentina: economic analysis

INTRODUCCIÓN: La Iniciativa Mundial de Erradicación de la Polio promueve la introducción de vacuna de polio inactivada (IPV) en sus programas, con la posterior retirada de Sabin (bOPV). OBJETIVO: Construir un modelo de económico que compare diferentes esquemas de vacunación para la prevención de polio y tosferina en el primer año de vida. Material y MÉTODOS: Análisis de cuatro escenarios de vacunación del esquema primario para Argentina, en base a los precios de las vacunas, costos del programa y reactogenicidad de vacuna celular o acelular para Bordetella pertussis: - Escenario 1 (caso base): dos dosis de IPV, una dosis de bOPV y tres dosis de vacuna pentavalente (DTwP-HB-Hib); - Escenario 2: tres dosis IPV y de pentavalente; - Escenario 3: tres dosis de hexavalente (DTaP-HepB-IPV-Hib); - Escenario 4: dos dosis de hexavalente más una dosis de pentavalente más IPV. RESULTADOS: El costo incremental en base al escenario 1 fue de USD 3.716.671; 19.696.668 y 14.383.341 para los escenarios 2, 3 y 4, respectivamente. Para la reactogenicidad, la diferencia fue de USD -14.178.240 comparado el caso base con el escenario 3. DISCUSIÓN: La inversión de incorporación de full IPV y costos asociados se modifica según tipo de vacuna y reactogenicidad asociada al componente B. pertussis.

BACKGROUND: Global Polio Eradication Initiative promotes the introduction of inactivated polio vaccine (IPV) in its programs, with withdrawal of Sabin (bOPV). There is no an economic analysis of the investment related to the incorporation of IPV vaccines together with a whole cell Bordetella pertussis vaccine or combined with acellular hexavalent. AIM: An economic model that compares different vaccination schemes for the prevention of polio and pertussis in the first year of life was carried out. METHODS: Four vaccination scenarios for the primary scheme based on Argentina demographic and costs data were developed: - Scenario 1 (base case): two doses of IPV, one dose of bOPV and three doses of pentavalent (DTwP-HepB-Hib) vaccine; - Scenario 2: three doses of IPV plus three doses of pentavalent; - Scenario 3: three doses of hexavalent; - Scenario 4: two doses of hexavalent plus one dose of pentavalent plus IPV. RESULTS: The incremental cost based on scenario 1 was USD 3.716.671; 19.696.668 and 14.383.341 for scenarios 2, 3 and 4 respectively. In terms of reactogenicity savings was -14.178.240 compared base case with scenario 3. DISCUSSION: Full IPV introduction investment and costs associated were modified according to the type of vaccine and reactogenicity related with the B. pertussis component.

Number of cases of varicella and hospitalization in a pediatric reference hospital in brazil after introducing the vaccine / Avaliação do número de casos e do perfil de internações por varicela em hospital pediátrico após a introdução da vacina

ABSTRACT Objective: To assess the number of cases and the profile of hospitalizations from varicella after the introduction of the measles, mumps, rubella and varicella combination vaccine in the public health system. Methods: Retrospective study in an infectious diseases pediatric hospital of reference in Southeast Brazil. The cases with a clinical diagnosis of varicella, from January 2011 to June 2016, were assessed from pediatricians' medical records. The hospitalizations were classified into a pre-vaccine group and post-vaccine group, based on the date the vaccine was introduced (September 2013). Both groups were compared by age, sex, time of hospitalization, reason for hospitalization, hospital complications, duration of intensive care, and clinical outcome. Results: A total of 830 hospitalizations were recorded; 543 in the pre-vaccine period and 287 in the post-vaccine period, a reduction of 47.1% (p<0.001). In both periods, a similar profile in the hospitalizations was noticed: majority male; aged between one to five years old; most complications due to secondary causes (mainly skin infections); main outcome was clinical improvement and discharge from the hospital. In the pre-vaccine period, six deaths were recorded and two were recorded in the post-vaccine period. Conclusions: The profile of the hospitalizations was expected to stay the same since this study did not compare vaccinated with unvaccinated children, but hospitalizations before and after the vaccine was introduced. In accordance with the medical literature, we found a significant fall in the number of hospitalizations from varicella.

RESUMO Objetivo: Avaliar o número de casos e o perfil das internações por varicela após a introdução da vacina quádrupla viral na rede pública. Métodos: Estudo retrospectivo conduzido em hospital pediátrico referência em doenças infectocontagiosas na Região Sudeste do Brasil. Foram avaliados os casos com diagnóstico clínico de varicela, registrados em prontuário por médico pediatra, de janeiro de 2011 até junho de 2016. As internações foram classificadas em grupo pré-vacinal e grupo pós-vacinal, com base na data de introdução da vacina (setembro de 2013). Os grupos foram comparados em relação a: faixa etária, sexo, tempo de hospitalização, causas da internação, complicações hospitalares, tempo da internação em terapia intensiva e desfecho clínico. Resultados: Foram documentadas 830 internações, 543 no período pré-vacinal e 287 no pós-vacinal, ocorrendo redução de 47,1% nas internações (p<0,001). Em ambos os períodos, notou-se um perfil similar das internações, predominantemente: sexo masculino; faixa etária de um a cinco anos; por causas secundárias (principalmente infecções de pele); evoluindo com melhora clínica e alta hospitalar. Em relação ao número de óbitos, ocorreram seis no período pré-vacinal e dois no pós-vacinal. Conclusões: A manutenção do perfil das internações era esperada, visto que o trabalho não comparou crianças vacinadas com não vacinadas, e sim internações pré e pós-vacinais. Observou-se, em concordância com a literatura, queda substancial no número de internações por varicela.

Lymphocyte proliferative responses in dairy cows supplemented with an immunomodulatory feed additive and administered polyvalent vaccination / [Proliferação de linfócitos em vacas leiteiras suplementadas com um aditivo alimentar imunomodulador e vacinadas com vacina polivalente]

O presente estudo avaliou o efeito da suplementação com OmniGen-AF® na proliferação de linfócitos e títulos de anticorpos após vacinação em bovinos leiteiros. Amostras de sangue periférico foram coletadas de 32 vacas leiteiras para quantificação dos títulos de anticorpos anti-Leptospira, e amostras de sangue periférico de 16 vacas leiteiras foram também coletadas para avaliação da proliferação de linfócitos. Observou-se que a suplementação com OmniGen-AF® aumentou a proliferação basal de linfócitos (sem estímulos) 21 dias após a vacinação (P=0,03), apesar de reduzir a proliferação de linfócitos B quando estimulada com Leptospira borgpetersenii serovar Hardjo inativada pelo calor (P=0,03). Ademais, nenhum efeito da suplementação sobre a proliferação de linfócitos no momento imediatamente anterior à vacinação e nos títulos de anticorpos anti-Leptospira foi encontrado. Além disso, a proliferação de linfócitos estimulada com lipopolissacarídeos foi maior em vacas multíparas que em primíparas 21 dias após a vacinação (P=0,03). Desse modo, o presente estudo demonstra que a suplementação com OmniGen-AF® não afetou de forma robusta a proliferação de linfócitos e os títulos de anticorpos anti-Leptospira após vacinação em vacas leiteiras sadias.(AU)

Evaluation of protection against bovine viral diarrhea virus type 2 after vaccination of the calves with bovine viral diarrhea virus type 1 combo inactivated vaccine / Avaliação da proteção contra o vírus da diarreia viral bovina tipo 2 após vacinação de bezerros com vacina combinada inativada do vírus da diarreia viral bovina tipo 1

This study was designed to evaluate the extent of the protection for bovine viral diarrhea virus type 2 (BVDV-2) infection, afforded by vaccination with a combo inactivated vaccine, which contains bovine viral diarrhea virus type 1 (BVDV-1) and infectious bovine rhinotracheitis virus (IBRV). Five 3-4-month-old calves were intramuscularly vaccinated with a single dose of the combo vaccine and boosted with same dose three weeks after the first vaccination, with five mock immunized calves serving as a control group. Twenty-one days after the second vaccination, all calves were challenged with BVDV-2 SX08 strain by spray into nostril. The unvaccinated animals developed typical clinical signs of high rectal temperature, diarrhoea with erosions and a dramatic drop in leukocyte counts. These signs occured markedly less in all vaccinated animals, the rectal temperature, leukopenia and virarmia of which, were significantly less than the mock immunized calves. It can be concluded that vaccination with the combo inactivated vaccine affords cross-protection against clinical effects of a challenge-infection with BVDV-2 SX08 strain, although it was part protection.(AU)

Este estudo foi desenvolvido para avaliar a extensão da proteção contra a infecção pelo vírus da diarréia viral bovina tipo 2 (BVDV-2) através da vacinação com uma vacina combinada inativada contendo o vírus da diarréia viral bovina tipo 1 (BVDV-1) e vírus da rinotraqueíte de bovinos infecciosos (IBRV). Cinco bezerros com 3 a 4 meses de idade foram vacinados via intramuscular com uma dose única da vacina combinada e reforçados com a mesma dose três semanas após a primeira vacinação, com cinco bezerros imunizados em simulação servindo como grupo controle. Vinte e um dias após a segunda vacinação, todos os bezerros foram desafiados com a cepa BVDV-2 SX08 por spray na narina. Os animais não vacinados desenvolveram sinais clínicos típicos, como alta temperatura retal, diarréia com erosões e queda drástica na contagem de leucócitos. Estes sinais tiveram ocorrência significativamente menor em todos os animais vacinados, cuja temperatura retal, leucopenia e virarmia eram significativamente menores do que os bezerros simulados. É possível concluir que a vacinação com a vacina combinada inativada proporciona proteção cruzada contra os efeitos clínicos de uma infecção provocada pela cepa BVDV-2 SX08, embora tenha sido parcialmente protegida.(AU)

Falhas vacinais: avaliando vacinas febre amarela, sarampo, varicela e caxumba / Fallos en vacunas: evaluando vacunas de fiebre amarilla, sarampión, varicela y parotiditis / Vaccine failures: assessing yellow fever, measles, varicella, and mumps vaccines

Resumo: A vacinação é uma das maiores intervenções em saúde pública pela segurança e efetividade, porém nem sempre vacinar significa imunizar. Inúmeros aspectos relacionados tanto ao indivíduo que recebe a vacina, quanto à especificidade de cada imunobiológico administrado compõem o processo para a obtenção de uma adequada imunização, sendo essencial que sejam observados para não culminar em falhas vacinais. A análise dos estudos de imunogenicidade e efetividade para as vacinas sarampo, varicela e caxumba apontam para a necessidade da incorporação de duas doses aos calendários básicos de vacinação para o controle das referidas doenças. Estudos epidemiológicos que analisaram surtos dessas doenças identificaram casos em indivíduos que receberam duas doses da vacina, o que pode apontar provável falha secundária. Para a vacina febre amarela, a discussão atual reside no número de doses ideal para a proteção individual. A Organização Mundial da Saúde recomenda dose única para toda a vida. Apesar dos poucos relatos em literatura a respeito das falhas vacinais, os estudos de imunogenicidade demonstram perda de proteção ao longo dos anos, principalmente na faixa etária pediátrica. Num cenário atual de eliminação e controle de doenças, associado à diminuição da circulação de vírus selvagens, o papel da vigilância epidemiológica é fundamental para aprofundar o conhecimento a respeito dos múltiplos fatores envolvidos, que culminam com falhas vacinais e surgimento de surtos. A ocorrência de surtos de doenças imunopreveníveis impacta negativamente a credibilidade dos programas de imunização, acarretando baixas coberturas vacinais e interferindo no êxito da vacinação.

Resumen: La vacunación es una de las mayores intervenciones en salud pública, por su seguridad y efectividad, sin embargo, no siempre vacunar significa inmunizar. Innumerables aspectos relacionados tanto con el individuo que recibe la vacuna, como con la especificidad de cada inmunobiológico administrado, componen el proceso para conseguir una adecuada inmunización, siendo esencial que sean observados para no acabar con fallos en las vacunas. El análisis de los estudios de inmunogenicidad y efectividad para las vacunas sarampión, varicela y parotiditis, apuntan hacia la necesidad de la incorporación de dos dosis a los calendarios básicos de vacunación para el control de las mencionadas enfermedades. Estudios epidemiológicos que analizaron brotes de esas enfermedades identificaron casos en individuos que recibieron dos dosis de la vacuna, lo que puede apuntar un probable fallo secundario. Para la vacuna de fiebre amarilla la discusión actual reside en el número de dosis ideal para protección individual. La Organización Mundial de la Salud recomienda una dosis única para toda la vida. A pesar de los pocos relatos en la literatura, respecto a los fallos en las vacunas, los estudios de inmunogenicidad demuestran una pérdida de protección a lo largo de los años, principalmente en la franja de etaria pediátrica. En un escenario actual de eliminación y control de enfermedades, asociado a la disminución de la circulación de virus salvajes, el papel de la vigilancia epidemiológica es fundamental para profundizar el conocimiento respecto a los múltiples factores implicados, que culminan con fallos en las vacunas y surgimiento de brotes. La ocurrencia de brotes de enfermedades inmunoprevenibles impacta negativamente en la credibilidad de los programas de inmunización, acarreando bajas coberturas de vacunación e interfiriendo en el éxito de la vacunación.

Abstract: Vaccination is one of the greatest public health interventions, based on its safety and effectiveness, but vaccination does not always mean immunization. Numerous aspects related both to the individual that receives the vaccine and the specificity of each vaccine administered are part of the process of obtaining adequate immunization, and it is essential to observe the aspects in order to avoid vaccine failures. The analysis of immunogenicity and effectiveness studies for the measles, varicella, and mumps vaccines point to the need to incorporate two doses into the basic vaccination calendars in order to control these diseases. Epidemiological studies that analyzed outbreaks of these diseases identified cases in individuals that received two doses of the vaccine, which may indicate likely secondary failure. For the yellow fever vaccine, the current discussion lies in the ideal number of doses for individual protection. The World Health Organization recommends a single dose for life. Despite the few reports in the literature concerning vaccine failures, immunogenicity studies demonstrate waning protection over the years, mainly in the pediatric age bracket. In the current scenario of elimination and control of diseases, associated with the decrease in the circulation of the wild-type viruses, the role of epidemiological surveillance is crucial for expanding knowledge on the multiple factors involved, culminating in vaccine failures and the emergence of outbreaks. Outbreaks of vaccine-preventable diseases negatively impact the credibility of immunization programs, leading to low vaccination coverage rates and interfering in vaccination's success.

Síndrome de Nicolau por la administración de la vacuna séxtuple intramuscular en un lactante de 6 meses / Nicolau syndrome induced by intramuscular injection of a hexavalent vaccine in a 6-month-old girl

El síndrome de Nicolau, también conocido como embolia cutis medicamentosa o dermatitis livedoide, es una reacción cutánea infrecuente, caracterizada por una necrosis de la piel y los tejidos blandos de aparición súbita luego de la aplicación intramuscular de algunas drogas. Presentamos a un bebé de 6 meses de edad que, al recibir la tercera dosis de la vacuna séxtuple intramuscular, desarrolló una lesión necrótica con reticulado violáceo periférico en el sitio de aplicación. Se destaca la importancia del diagnóstico precoz a fin de instaurar un adecuado tratamiento y seguimiento para evitar complicaciones secundarias a la isquemia.

Nicolau syndrome, also known as embolia cutis medicamentosa or livedo-like dermatitis, is a sudden tissue necrosis, a rare complication of intramuscular injection of some drugs. We report a case of a 6-month-old girl who received intramuscularly the third dose of hexavalent vaccine (DTaP-HVB-IPV/HIb), and immediately presented a livedoid lesion around the injection site, progressing to necrosis. We reinforce the importance of early diagnosis to perform a suitable treatment and clinical follow-up to avoid ischemic secondary complications.

Guías para la inmunización del adolescente y adulto en Colombia. Documento de actualización, 2016 / Guidelines for the immunization of adolescents and adults living in Colombia. Update document, 2016

Este documento fue preparado por un grupo multidisciplinario de expertos seleccionados por la Asociación Colombiana de Infectología (ACIN) para poner al día las recomendaciones previas dadas por nuestro grupo en cuanto a la inmunización del adolescente, de la población adulta y de aquellos mayores de 60 años de edad. Para este último grupo, hemos decidido, como lo han hecho en otros países, el inmunizar a esta edad (y no después), debido a la carga de enfermedad incrementada por afecciones respiratorias y otros factores propios para América Latina y las condiciones socioeconómicas de nuestro país. Esta edición reescribe ciertos párrafos y actualiza en parte las recomendaciones hechas anteriormente y publicadas en Infectio en mayo de 2012. Las guías están orientadas al uso por aquellos que cuidan de estos pacientes y hacemos énfasis en el anciano, el inmunocomprometido y en aquellos que sufren de varias comorbilidades. Aunque en un momento dado el documento pudiera parecer incompleto, la intención deseada fue la de abarcar los recientes cambios en la administración de nuevas vacunas y otros regímenes en dosificación. Se incluye por primera vez el uso de las vacunas de 4 valencias contra la influenza. El uso de la vacuna contra el herpes zóster se discute, y se toma un cuidado especial en cuanto a la redacción del "cuándo y por qué" de la vacunación contra Streptococcus pneumoniae. En la administración de esta vacuna, el tiempo de aplicación y la secuencia asociada con la aplicación de la administración de la vacuna polisacárida de 23 valencias puede variar de acuerdo con la edad del paciente,las comorbilidades y en aquellos previamente vacunados con dicha vacuna. Finalmente, exponemos las nuevas recomendaciones de vacunación contra fiebre amarilla y dengue y le damos la bienvenida a la vacuna nonavalente contra el virus humano del papiloma.

This document was prepared by a multi-disciplinary panel of experts who have been selected by the Asociación Colombiana de Infectologia (ACIN) to revise and update previous recommendations (by our group) for the immunization of adolescents and adult population and those older than 60 years of age. For the latter group, we have chosen to move forward, like many others, and immunize them at that age because of the particular burden of disease due to respiratory conditions, and other factors strictly related to Latin America and Colombian socio-economic conditions. This edition replaces in part, updates or ads to previous recommendations published in Infectio, May 2012. The guidelines are intended to assist those caring for these patients, and emphasizes on the elderly, the immunocompromissed and on those who suffer from several co-morbidities.The contents of the guidelines could seem in complete at some point; nevertheless, they were purposefully thought as such to embrace on major changes in new vaccines or new dosin gregimens. It is included for the first time the use of cuadri-valent vaccines against influenza. The use of herpes zoster vaccine is discussed and special care is placed in the phrasing for the reader so he (she) understands the "when and why" of vaccine administration against Streptococcus pneumoniae. With pneumococcal vaccines, timing of administration may vary according to age, co-morbidities and in those previously vaccinated with the 23-polyvalent polysaccharide vaccine. There are new recommendations for the vaccination against yellow fever and dengue and we welcome the new nona-valent vaccine against the human papillomavirus.

Varicella zoster virus related deaths and hospitalizations before the introduction of universal vaccination with the tetraviral vaccine / Óbitos e internações relacionados ao vírus varicela-zoster antes da introdução da vacinação universal com a vacina tetravalente

Abstract Objective: To characterize varicella zoster virus-related deaths and hospitalizations in Brazil before universal vaccination with the tetravalent (measles, mumps, rubella, and varicella) vaccine, attempting to collect baseline data on varicella morbidity and mortality in order to evaluate the impact of the varicella vaccination program. Methods: Varicella-associated mortality data were evaluated between 1996 and 2011 and varicella zoster virus-associated hospitalizations between 1998 and 2013. Data were gathered from the Informatics Department of the Unified Health System, considering the International Classification of Diseases, 10th Revision, code B01. All age groups were assessed. Varicella-specific mortality rates were calculated and seasonality of varicella-zoster virus-associated hospitalizations was described. Results: There were 2334 varicella deaths between 1996 and 2011, 19.3% in infants aged less than 1 year and 36% in children from 1 to 4 years. In infants under 1 year, varicella mortality rates reached 3.2/100,000/year. In children aged 1–4 years, varicella mortality rates reach 1.64/100,000/year. Average annual mortality rates for varicella in Brazil are 0.88/100,000 in infants under 1 year and 0.40/100,000 in children aged 1–4 years. The total number of hospitalizations associated with varicella zoster virus was 62,246 from 2008 to 2013. Varicella-associated hospitalizations have a seasonal distribution in children, peaking in November. In the elderly, monthly averages of herpes zoster-associated hospitalizations present no significant seasonal variation. Conclusions: Varicella is associated, in the pre-vaccine period, to significant morbidity and mortality in Brazil. The universal vaccination program is expected to decrease the disease burden from varicella.

Resumo Objetivo: Caracterizar os óbitos e internações relacionados ao vírus varicela-zoster no Brasil antes da vacinação universal com a vacina tetravalente (sarampo, caxumba, rubéola e varicela), tentando coletar dados de referência sobre a morbidez e mortalidade por varicela, para avaliar o impacto do programa de vacinação contra a varicela. Métodos: Os dados de mortalidade associada à varicela foram avaliados entre 1996 e 2011 e as internações associadas ao vírus varicela-zoster, entre 1998 e 2013. Os dados foram coletados do Departamento de Informática do Sistema Unificado de Saúde, considerando a Classificação Internacional de Doenças, 10ª Revisão, código B01. Todas as faixas etárias foram avaliadas. Foram calculadas as taxas de mortalidade específicas por varicela e foi descrita a sazonalidade das internações associadas ao vírus varicela-zoster. Resultados: Houve 2.334 óbitos por varicela entre 1996 e 2011, 19,3% em neonatos com menos de 1 ano e 36% em crianças de 1 a 4 anos. Em neonatos com menos de 1 ano, as taxas de mortalidade por varicela atingiram 3,2/100.000/ano. Em crianças de 1–4 anos de idade, as taxas de mortalidade por varicela atingem 1,64/100.000/ano. As taxas de mortalidade anuais médias por varicela no Brasil são de 0,88/100.000 em neonatos com menos de 1 ano de idade e 0,40/100.000 em crianças de 1 a 4 anos de idade. O número total de internações associadas ao vírus varicela-zoster foi de 62.246 de 2008 a 2013. As internações relacionadas à varicela apresentaram distribuição sazonal em crianças, com pico em novembro. Em idosos, as médias mensais de internações associadas ao herpes zoster não apresentam variação sazonal significativa. Conclusões: A varicela está associada a morbidez e mortalidade significativas no período pré-vacinação no Brasil. O programa de vacinação universal deve diminuir a carga de doença da varicela.

A prevenção da infecção pelo HPV e o câncer cervical / Prevention of HPV infection and cervical cancer

O Papilomavírus Humano está comprovadamente associado ao surgimento de lesões benignas e malignas incluindo o câncer do colo do útero. Mesmo sendo uma patologia com bons métodos de rastreio e diagnóstico precoce, anualmente milhares de mulheres em todo o mundo são acometidas pela infecção e posterior surgimento de lesões a esse vírus associadas, principalmente em países mais pobres. Após o entendimento destes vírus e de suas micropartículas, foram realizados estudos para a tentativa da produção de um agente imunizador que pudesse servir de prevenção primária para reduzir os níveis tão elevados desta doença e as mortes por ela provocadas em todo o mundo. No Brasil, a vacina foi instituída no Programa de Nacional de Imunizações em 2014. Mas ainda não há dados de seguimento para avaliar o impacto dessa prevenção no futuro. Este estudo tem como meta fazer uma revisão dos principais aspectos do Papilomavírus Humano e os comentários das vacinas já aprovadas para utilização.(AU)

The human papillomavirus is demonstrably associated with the development of benign and malignant lesions including cervical cancer. Although it is a good condition to methods of screening and early diagnosis annually thousands of women worldwide are affected by the infection and subsequent appearance of lesions associated with this virus, especially in poorer countries. After understanding these viruses and their microparticles studies were performed to attempt the production of an immunizing agent that could serve as the primary prevention to reduce such high levels of this illness and deaths caused by it worldwide. In Brazil, the vaccine was introduced in the National Immunization Program in 2014. But there is no tracking data to evaluate the impact of prevention in the future. This study aims to review the main aspects of the human papillomavirus, the main injuries and vaccines already approved for use.(AU)

Internações sensíveis à atenção primária específicas de mulheres / Sensitive female-specific hospitalization in primary care

Objetivou-se analisar as internações por condições sensíveis à atenção primária (ICSAP) específicas em mulheres e os fatores que determinam ou influenciam a ocorrência dessas internações (fatores socioeconômicos, sociodemográficos e controle de saúde) por meio de um inquérito de morbidade hospitalar realizado com amostra de 429 mulheres internadas em hospitais conveniados ao Sistema Único de Saúde. O percentual de ICSAP foi 49,42% (n = 212), com destaque para as internações específicas do sexo feminino 19,35% (n = 83). Associaram ao risco de internar por CSAP: idade superior a 60 anos, baixa escolaridade, internação prévia, realização de controle regular de saúde, falta de vínculo com a Estratégia Saúde da Família (ESF) e ser gestante. As causas evidentes foram as condições relacionadas à gravidez, ao parto e ao puerpério e às inflamações nos órgãos pélvicos femininos. Os resultados sugerem falhas no atendimento ambulatorial que deveria ser oportuno e resolutivo no contexto da saúde da mulher.

The scope of this paper was to analyze female-specific sensitive hospitalization occurring in primary care conditions and factors that determine or affect the occurrence of such hospitalizations (social, economic and demographic factors; health control). Analysis was performed by surveys on hospital morbidity with a sample of 429 females attended in Unified Health System (SUS) contracted hospitals. The sensitive hospitalizations percentage in primary care reached 49.42% (n = 212), highlighting female-specific hospitalization at 19.35% (n = 83). Hospitalization risks comprised elderly people over sixty, low schooling, previous hospitalizations, normal health control, lack of association with the Family Health Strategy and pregnancy. Evident causes were related to conditions of pregnancy, childbirth, post-partum and inflammations of the female pelvic organs. Results suggested flaws in outpatient attendance that should be adequate and provide solutions in women’s health.

Comparison of combined immunization schemes influence on anti-HBs of babies born to mothers with high-load hepatitis B virus infection / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To compare the various combined immunization schemes available for treatment of babies born to mothers with high-load hepatitis B virus (HBV) infection.</p><p><b>METHODS</b>A total of 118 mothers with HBV infection status of hepatitis B surface antigen-positive (HBsAg+), hepatitis B e antigen-positive (HBeAg+) and HBV DNA load of more than 1.0 * 61og10 IU/mL were included in the study. All of the participants' babies received the main-passive immunization therapy according to the wishes of their families. For analysis,the infants were grouped according to the various dosages of the vaccine program (group A: hepatitis B immunoglobulin (HBIG) 200 IU and HBVac 20 mug intramuscular;group B:HBIG 200 IU and HBVac 10 mug intramuscular; group C HBIG 100 IU and HBVac 20 mug intramuscular injection) and times, and followed-up to 7 months of age.All results were statistically analyzed using SPSS software.</p><p><b>RESULTS</b>All of the infants produced anti-HBs after vaccination.After the HBIG injection schedule was completed in January, the mean concentrations of anti-HBs in groups A, B, and C were 263.56 ± 50.98,231.06 ± 74.07, and 99.23 ± 29.82 mIU/mL respectively;the concentrations were significantly different between groups A and C, and between groups B and C (P < 0.001). In July, the titers of anti-HBs in groups A, B, and C were 788.10 ± 281.96,428.39 ± 347.48, and 708.44 ± 315.69 mIU/mL respectively; the concentrations were significantly different between groups A and B, and between groups B and C (P < 0.05).</p><p><b>CONCLUSION</b>AdminisWation of the hepatitis B vaccine combined with HBIG at birth can achieve immune protection for babies born to highly viremic mothers. In January, the HBIG dosage of 200 IU was more reliable than 100 IU. The hepatitis B 20 tg dose vaccine was safe and effective.</p>

Clinical observation of telbivudine's antiviral efficacy and protection against mother-to-infant transmission of chronic hepatitis B during the first trimester of pregnancy / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To explore the antiviral efficacy, safety and protective ability against mother-to-infant transmission of telbivudine in pregnant patients with chronic hepatitis B (CHB) during the first trimester.</p><p><b>METHODS</b>Eighty four gravid women who were diagnosed with CHB, in their first trimester of pregnancy, and had refused to terminate their pregnancies were enrolled; all study participants were clinically classified as active hepatitis cases with positivity for both hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg), HBV DNA more than or equal to 107 copies/mL and serum level of alanine aminotarnsferase (ALT) of more than or equal to 4 ULN.Patients with YMDD mutations were excluded from the study. The study participants were divided into a telbivudine treatment group (n=43; administered in the first trimester of pregnancy) and a control group (n=41, consisting of patients who refused to take antivirals). All babies bom to the women in both groups of the study received standard immune prevention (anti-hepatitis B immunoglobulin plus hepatitis B vaccine) and artificial feeding.Data recorded for the women during pregnancy included clinical findings for tests of hepatic and renal function, myocardial enzymes, blood and urine clinical parameters, hepatitis B virus makers and HBV DNA, as well as notation of any adverse reactions. The neonates were evaluated for presence of HBV infection, parameters of growth and development, presence of complications, and Apgar score. At 6 and 12 months old, all infants were evaluated for HBV DNA level and HBsAg presence.</p><p><b>RESULTS</b>The genetic variant rtM204I was detected in one of the women in the treatment group at 36 weeks of pregnancy. One woman in the control group developed severe hepatitis at 28 weeks of pregnancy and was put on the telbivudine treatment The treatment group showed greater recovery rates of ALT than the control group at 12 weeks of pregnancy (62.8% vs.29.3%, P=0.002), 24 weeks of pregnancy (76.7% vs.46.3%, P=0.000), and at ante partum (88.1% vs.60.0%, P=0.004). The treatment group also showed greater HBV DNA-negative conversion rates at 12 weeks of pregnancy (20.9% vs.0, P=0.006), at 24 weeks of pregnancy (37.2% vs.0, P=0.001) and at ante partum (78.6% vs.0, P=0.000), and greater HBeAg seroconversion rates at 12 weeks of pregnancy (2.3% vs.0, P=1.000), at 24 weeks of pregnancy (9.3% vs.0, P=0.116) and at ante partum (2 1.4% vs.0, P=0.002). The HBsAg-positive rates and HBV DNA-positive rates among the infants born to the mothers in the treatment and control groups, respectively, were 2.4% vs.17.5% (P=0.027) at birth, 0 vs.17.5% (P=0.005)at 6 months old and 0 vs.17.5% (P=0.005) at 12 months old. The Apgar scores were not significantly different for the children born to the mothers from the two groups, and all the children showed parameters of growth development within normal limits.</p><p><b>CONCLUSION</b>Telbivudine administration in the first trimester had a good antiviral curative effect and effectively blocked mother-to-infant transmission in women with CHB. The treatment was safe, causing no obvious adverse reaction in the gravid women or developmental effects on the infants.</p>