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1.
Rev. esp. quimioter ; 32(5): 432-439, oct. 2019. ilus, tab, graf
Artigo em Espanhol | IBECS | ID: ibc-ET5-96

RESUMO

OBJETIVOS: Describir el tipo de vacunas administradas en la Unidad de Vacunas de un hospital de referencia y calcular la tasa de notificación global y específica de las reacciones adversas asociadas. MÉTODOS: Estudio observacional retrospectivo, realizado en el periodo entre noviembre de 2014 y noviembre de 2017, de los pacientes que desarrollaron una reacción adversa a medicamento (RAM) tras la administración de una vacuna y que fue notificada al Sistema Español de Farmacovigilancia. Las variables analizadas fueron edad, sexo, grupo de riesgo, tipo de vacuna, coadministración y tipo de RAM. Se llevó a cabo un análisis univariante y bivariante. Se calculó la tasa de notificación de RAM global y específica para cada vacuna. RESULTADOS: Se administraron un total de 18.123 vacunas de las que el 20,7% correspondían a la vacuna frente al virus de la hepatitis B. Se notificaron 53 sospechas de RAM. En el 64,2% de las ocasiones se había administrado solamente una vacuna. El 88,7% de las notificaciones correspondieron a vacunas inactivadas. La vacuna frente neumococo polisacárida de 23 serotipos fue la que generó el mayor número de notificaciones. La tasa de notificación global de RAM fue de 0,42%. La vacuna hexavalente fue la que registró la tasa de notificación más elevada (2,81%). El 49,1% de las RAM fueron de tipo sistémico. CONCLUSIONES: La tasa de notificación global fue baja aunque superior a la registrada por otros autores. La correcta notificación de posibles reacciones adversas postvacunales es imprescindible para contribuir a la seguridad vacunal y para aumentar la confianza de la población en las vacunas


OBJECTIVES: The aim of the study was to describe the type of vaccines administered in the Vaccine Unit at a reference hospital. Calculate the overall and specific reporting rate of adverse reactions. METHODS: Retrospective observational study for the period between November 2014 and November 2017, on patients who developed an adverse drug reaction (ADR) after the administration of a vaccine and who were notified to the Spanish Pharmacovigilance System. The variables analyzed were age, sex, risk group, vaccine class, co-administration and type of ADR. A univariate and bivariate analysis was performed. The global and vaccine specific rate of ADR notification was calculated. RESULTS: A total of 18,123 vaccines were administered, of which 20.7% corresponded to hepatitis B virus vaccine. Fifty-three RAM suspects were reported. In 64.2% of cases only one vaccine was administered. Inactivated vaccines accounted for 88.7% of notifications. The highest number of notifications was generated by the 23 serotypes pneumococcal polysaccharide vaccine. The overall reporting rate was 0.42%. The hexavalent vaccine had the highest reporting rate (2.81%).49.1% of the ADR were systemic. CONCLUSIONS: The overall reporting rate was low but higher than that of other authors. Proper reporting of possible adverse post-vaccine reactions is essential to contribute to vaccine safety and to increase public confidence in vaccines


Assuntos
Humanos , Masculino , Feminino , Criança , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Hospedeiro Imunocomprometido , Farmacovigilância , Vacinas/efeitos adversos , Análise de Variância , Pré-Escolar , Vacinas contra Hepatite B/administração & dosagem , Vacinas contra Hepatite B/efeitos adversos , Fotografação , Vacinas Pneumocócicas/administração & dosagem , Vacinas Pneumocócicas/efeitos adversos , Estudos Retrospectivos , Espanha , Vacinas Estreptocócicas/administração & dosagem , Vacinas Estreptocócicas/efeitos adversos , Vacinas/administração & dosagem , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos
2.
Rev. esp. quimioter ; 32(5): 440-444, oct. 2019. graf
Artigo em Espanhol | IBECS | ID: ibc-ET5-97

RESUMO

OBJETIVO: El objetivo es evaluar las nuevas infecciones por el virus de la hepatitis C (VHC) en función de su orientación sexual, situación serológica respecto al virus de la inmunodeficiencia humana (VIH), región geográfica de origen y la coinfección con otras infecciones de transmisión sexual (ITS). MATERIAL Y MÉTODOS: Estudio realizado en el Centro Sanitario Sandoval clínica de referencia de ITS en Madrid. Se incluyeron todas las personas seronegativas al VHC que fueron reanalizadas para este virus, entre enero de 2010 y diciembre de 2016. RESULTADOS: Se diagnosticaron 59 nuevos diagnósticos de infección por el VHC. La proporción de hombres que tienen sexo con hombres (HSH) dentro de los nuevos diagnósticos fue del 37% en 2010 y del 75% en 2016 y, fue aún mayor, en el grupo de coinfectados por el VIH/VHC (94%). Se detectaron 67 seroconvertores al VHC (1,2%). El 100% eran HSH. El 89% de los seroconvertores al VHC eran seropositivos para el VIH. CONCLUSIONES: La infección por el VHC sigue siendo un problema de salud vigente, especialmente en colectivos de riesgo, como los HSH seropositivos para el VIH


INTRODUCTION: The aim of this study was to evaluate the incidence of new hepatitis C virus (HCV) infections, based on their sexual orientation, human immunodeficiency virus (HIV) status, geographical regions and coinfection with other sexually transmitted diseases (STDs). MATERIAL AND METHODS: This study was carried out at the Sandoval Health Center, reference clinic of Sexually Transmitted Diseases (STDs) in Madrid. All HCV seronegative individuals who were reanalyzed for this virus were included, between January 2010 and December 2016. RESULTS: A total of 59 new diagnoses of HCV were diagnosed. The proportion of men who have sex with men (MSM) diagnosed with HCV was 37% in 2010 and 75% in 2016 and was even higher in the group of coinfected with HIV/HCV (94%). A total of 67 seroconverters for HCV were detected (1.2%) of which 100% were MSM. The proportion of HCV seroconverters with HIV was 89%. CONCLUSIONS: HCV infection continues to be a current health problem, especially in HIV-positive MSM


Assuntos
Humanos , Masculino , Feminino , Pré-Escolar , Criança , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Hospedeiro Imunocomprometido , Farmacovigilância , Vacinas/efeitos adversos , Análise de Variância , Vacinas contra Hepatite B/administração & dosagem , Vacinas contra Hepatite B/efeitos adversos , Fotografação , Vacinas Pneumocócicas/administração & dosagem , Vacinas Pneumocócicas/efeitos adversos , Estudos Retrospectivos , Espanha , Vacinas Estreptocócicas/administração & dosagem , Vacinas Estreptocócicas/efeitos adversos , Vacinas/administração & dosagem , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos
3.
Rev Esp Quimioter ; 32(5): 432-439, 2019 Oct.
Artigo em Espanhol | MEDLINE | ID: mdl-31558008

RESUMO

OBJECTIVE: The aim of the study was to describe the type of vaccines administered in the Vaccine Unit at a reference hospital. Calculate the overall and specific reporting rate of adverse reactions. METHODS: Retrospective observational study for the period between November 2014 and November 2017, on patients who developed an adverse drug reaction (ADR) after the administration of a vaccine and who were notified to the Spanish Pharmacovigilance System. The variables analyzed were age, sex, risk group, vaccine class, co-administration and type of ADR. A univariate and bivariate analysis was performed. The global and vaccine specific rate of ADR notification was calculated. RESULTS: A total of 18,123 vaccines were administered, of which 20.7% corresponded to hepatitis B virus vaccine. Fifty-three RAM suspects were reported. In 64.2% of cases only one vaccine was administered. Inactivated vaccines accounted for 88.7% of notifications. The highest number of notifications was generated by the 23 serotypes pneumococcal polysaccharide vaccine. The overall reporting rate was 0.42%. The hexavalent vaccine had the highest reporting rate (2.81%). 49.1% of the ADR were systemic. CONCLUSIONS: The overall reporting rate was low but higher than that of other authors. Proper reporting of possible adverse post-vaccine reactions is essential to contribute to vaccine safety and to increase public confidence in vaccines.


Assuntos
Hospedeiro Imunocomprometido , Farmacovigilância , Vacinas/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Criança , Pré-Escolar , Feminino , Vacinas contra Hepatite B/administração & dosagem , Vacinas contra Hepatite B/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Fotografação , Vacinas Pneumocócicas/administração & dosagem , Vacinas Pneumocócicas/efeitos adversos , Estudos Retrospectivos , Espanha , Vacinas Estreptocócicas/administração & dosagem , Vacinas Estreptocócicas/efeitos adversos , Vacinas/administração & dosagem , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Adulto Jovem
4.
Fish Shellfish Immunol ; 94: 249-257, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31470139

RESUMO

In recent years, streptococcal diseases have severely threatened the development of tilapia aquaculture, but effective prevention and control methods have not yet been established. To understand the immune responses of vaccinated Nile tilapia (Oreochromis niloticus), digital gene expression (DGE) technology was applied in this study to detect the gene expression profile of the Nile tilapia (O. niloticus) liver in response to ScpB (Streptococcal C5a peptidase from group B Streptococcus, ScpB) vaccination and a Streptococcus agalactiae-challenge. The control and the ScpB-vaccinated Nile tilapia yielded a total of 25,788,734 and 27,088,598 clean reads, respectively. A total of 1234 significant differentially expressed unigenes were detected (P < 0.05), of which 236 were significantly up-regulated, and 269 were significantly down-regulated (P < 0.05, |fold|>2, FDR<0.05). Of the differentially expressed gene, the identified genes which were enriched using databases of GO and KEGG could be categorized into a total of 67 functional groups and were mapped to 153 signaling pathways including 15 immune-related pathways. The differentially expressed genes (TLR1, TLR2, TLR3, TLR5, TLR9, MyD88, C3, IL-1ß, IL-10) were detected in the expression profiles, and this was subsequently verified via quantitative real-time PCR (qPCR). The results of this study can serve as a basis for future research not only on the molecular mechanism of S. agalactiae invasion, but also on the anti-S. agalactiae mechanism in targeted tissues of Nile tilapia.


Assuntos
Ciclídeos/imunologia , Doenças dos Peixes/genética , Perfilação da Expressão Gênica/veterinária , Regulação da Expressão Gênica , Infecções Estreptocócicas/veterinária , Streptococcus agalactiae/fisiologia , Animais , Ciclídeos/genética , Regulação para Baixo , Doenças dos Peixes/imunologia , Doenças dos Peixes/microbiologia , Biblioteca Gênica , Ontologia Genética , Fígado/metabolismo , Fígado/microbiologia , Infecções Estreptocócicas/genética , Infecções Estreptocócicas/imunologia , Infecções Estreptocócicas/microbiologia , Vacinas Estreptocócicas/administração & dosagem , Regulação para Cima
5.
mBio ; 10(2)2019 04 30.
Artigo em Inglês | MEDLINE | ID: mdl-31040243

RESUMO

Group A Streptococcus (GAS) infections account for an estimated 500,000 deaths every year. This bacterial pathogen is responsible for a variety of mild and life-threatening infections and the triggering of chronic autoimmune sequelae. Pharyngitis caused by group A Streptococcus (GAS), but not asymptomatic GAS carriage, is a prerequisite for acute rheumatic fever (ARF). Repeated bouts of ARF may trigger rheumatic heart disease (RHD), a major cause of heart failure and stroke accounting for 275,000 deaths annually. A vaccine that prevents pharyngitis would markedly reduce morbidity and mortality from ARF and RHD. Nonhuman primates (NHPs) have been utilized to model GAS diseases, and experimentally infected rhesus macaques develop pharyngitis. Here we use an NHP model of GAS pharyngitis to evaluate the efficacy of an experimental vaccine, Combo5 (arginine deiminase [ADI], C5a peptidase [SCPA], streptolysin O [SLO], interleukin-8 [IL-8] protease [SpyCEP], and trigger factor [TF]), specifically designed to exclude GAS components potentially linked to autoimmune complications. Antibody responses against all Combo5 antigens were detected in NHP serum, and immunized NHPs showed a reduction in pharyngitis and tonsillitis compared to controls. Our work establishes the NHP model as a gold standard for the assessment of GAS vaccines.IMPORTANCE GAS-related diseases disproportionally affect disadvantaged populations (e.g., indigenous populations), and development of a vaccine has been neglected. A recent strong advocacy campaign driven by the World Health Organization and the International Vaccine Institute has highlighted the urgent need for a GAS vaccine. One significant obstacle in GAS vaccine development is the lack of a widely used animal model to assess vaccine efficacy. Researchers in the field use a wide range of murine models of infection and in vitro assays, sometimes yielding conflicting results. Here we present the nonhuman primate pharyngeal infection model as a tool to assess vaccine-induced protection against colonization and clinical symptoms of pharyngitis and tonsillitis. We have tested the efficacy of an experimental vaccine candidate with promising results. We believe that the utilization of this valuable tool by the GAS vaccine research community could significantly accelerate the realization of a safe and effective GAS vaccine for humans.


Assuntos
Faringite/prevenção & controle , Infecções Estreptocócicas/prevenção & controle , Vacinas Estreptocócicas/imunologia , Streptococcus pyogenes/imunologia , Tonsilite/prevenção & controle , Animais , Anticorpos Antibacterianos/sangue , Modelos Animais de Doenças , Feminino , Macaca mulatta , Masculino , Vacinas Estreptocócicas/administração & dosagem , Resultado do Tratamento
6.
Rev. esp. quimioter ; 32(2): 98-113, abr. 2019. ilus, tab
Artigo em Espanhol | IBECS | ID: ibc-182811

RESUMO

El síndrome de Austrian es una patología producida por la infección diseminada de Streptococcus pneumoniae y caracterizada por la tríada de neumonía, endocarditis y meningitis Tiene una incidencia estimada de 0,9-7,8 casos por diez millones de habitantes y año y una mortalidad del 32%. El consumo de alcohol, como principal factor de riesgo, aparece solamente en cuatro de cada diez pacientes. Un 14% no presentan factores de riesgo. Dos de cada tres enfermos son varones y ocurre en la época media de la vida. Asienta sobre válvula nativa, lesionándose la aorta en la mitad de los afectados. Presentan regurgitación severa dos de cada tres pacientes. El tratamiento antimicrobiano apropiado y la cirugía temprana de la endocarditis disminuyen la mortalidad. Es posible que la epidemiología del síndrome de Austrian esté cambiando por la introducción de la vacuna antineumocócica conjugada 13-valente en el calendario infantil


The Austrian syndrome is a pathology caused by disseminated Streptococcus pneumoniae infection and characterized for the triad of pneumonia, endocarditis and meningitis. It has an estimated incidence of 0.9-7.8 cases per ten millions people each year, and a mortality of 32%. Alcohol abuse, as the main risk factor, appears only in four out of ten patients. Moreover, 14% of patientes do not have any risk factor. Two out of three patients are males and it occurs in the middle aged of life. It is more frequently on native valve, aortic valve is injured in the half of the cases. Severe regurgitation occurs in two per three patients. Appropriate antimicrobial treatment and early endocarditis surgery decrease mortality. It is possible that Austrian syndrome epidemiology is changing by the introduction of 13-valent pneumococcal conjugated vaccine in the children's calendar


Assuntos
Humanos , Masculino , Adulto , Infecções Pneumocócicas/complicações , Streptococcus pneumoniae/patogenicidade , Derrame de Bactérias , Pneumonia Pneumocócica/complicações , Antibacterianos/uso terapêutico , Meningites Bacterianas/complicações , Vacinas Estreptocócicas/administração & dosagem , Acidente Vascular Cerebral/etiologia , Perda Auditiva Neurossensorial/etiologia
7.
Hum Vaccin Immunother ; 15(1): 193-202, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30130440

RESUMO

Group B streptococcus (GBS) is a leading bacterial cause of neonatal sepsis and meningitis in many countries as well as an important cause of disease in pregnant women. Currently, serotype-specific conjugate vaccines are being developed. We conducted an epidemiological analysis of health administrative data to estimate the burden of infant GBS disease in Ontario, Canada and combined these estimates with literature on serotype distribution to estimate the burden of disease likely to be vaccine-preventable. Between 1st January 2005 and 31st December 2015, 907 of 64320 health care encounters in Ontario in patients under 1 year old had codes specifically identifying GBS as the cause of the disease, of which 717 were under one month of age. In addition, application of epidemiological data to the remaining patients allowed us to estimate a further 2322 cases and among them 1822 were under one month of age. In the same period, 579 confirmed neonatal invasive GBS cases in patients up to one month of age were reported to public health. Depending on serotype distribution, vaccination coverage and early versus late onset disease (0-6 days and 7-90 days of age respectively), the preventable fraction ranged widely. With a vaccine that is 90% effective and 60% immunization coverage, up to 52% of early and late onset disease could be prevented by forthcoming vaccines. GBS is under-reported in Ontario. Uncertainty about the potential impact of vaccine indicates that further analysis and research may be needed to prepare for policy-decision making, including clinical validation studies and an economic evaluation of GBS vaccination in Ontario.


Assuntos
Efeitos Psicossociais da Doença , Administração de Serviços de Saúde , Infecções Estreptocócicas/economia , Infecções Estreptocócicas/epidemiologia , Cobertura Vacinal , Análise Custo-Benefício , Análise de Dados , Feminino , Humanos , Lactente , Recém-Nascido , Ontário/epidemiologia , Gravidez , Complicações Infecciosas na Gravidez/prevenção & controle , Vacinas Estreptocócicas/administração & dosagem , Vacinação/economia
8.
Fish Shellfish Immunol ; 86: 999-1008, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30590166

RESUMO

Streptococcus agalactiae infections are becoming an increasing problem in aquaculture because of significant morbidity and mortality, which restricts the healthy development of tilapia aquaculture. To seek safe and effective prevention measures, a Bacillus subtilis GC5 surface displayed vaccine was prepared and applied orally in tilapia. The study first showed that recombinant spores can engraft in the tilapia intestine. Then, the effect of protection and the immune responses were evaluated. The results of ELISA showed that Sip-specific antibody in the sera of GC5-Sip-immunized fish can be detected after the first oral administration when compared to the phosphate buffer saline (PBS) control group, and the levels of specific IgM gradually strengthened with boosting, so does the specific antibody against bacteria, proving that humoral immunity was induced. Quantitative real-time PCR (qRT-PCR) results showed that the immune-related gene expression of the gut and spleen exhibited a different rising trend in the GC5-Sip group, revealing that innate immune response and local as well as systemic cellular immunity were induced. The outcome of fish immunized with GC5-Sip spores provided a relative percent survival (RPS) of 41.7% against S. agalactiae and GC5 group had an RPS of 24.2%, indicating that GC5-Sip was safe and effective in protecting tilapia against bacterial infection. Our study demonstrated that the oral administration of B. subtilis spores expressing Sip could cause an effective immune response and offer good resistance to bacterial infection. Our work may lead to the development of new ideas for immunoprophylaxis against S. agalactiae infection.


Assuntos
Doenças dos Peixes/prevenção & controle , Vacinas Estreptocócicas/imunologia , Streptococcus agalactiae/imunologia , Tilápia , Administração Oral , Animais , Bacillus subtilis/metabolismo , Proteínas de Bactérias/imunologia , Doenças dos Peixes/microbiologia , Esporos Bacterianos , Infecções Estreptocócicas/prevenção & controle , Vacinas Estreptocócicas/administração & dosagem , Vacinação
9.
Microbiol Immunol ; 62(11): 711-719, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30357922

RESUMO

Protein subunit vaccines are often preferred because of their protective efficacy and safety. Lactic acid bacteria expressing heterologous antigens constitute a promising approach to vaccine development. However, their safety in terms of toxicity and bacterial clearance must be evaluated. Anti-Streptococcus pyogenes (S. pyogenes) vaccines face additional safety concerns because they may elicit autoimmune responses. The assessment of toxicity, clearance and autoimmunity of an anti-streptococcal vaccine based on Lactococcus lactis (L. lactis) expressing 10 different M protein fragments from S. pyogenes (L. lactis-Mx10) is here reported. Clearance of L. lactis from the oropharynges of immunocompetent mice and mice devoid of T/B lymphocytes mice was achieved without using antibiotics. The absence of autoimmune responses against human tissues was demonstrated with human brain, heart and kidney. Assessment of toxicity showed that leucocyte counts and selected serum biochemical factors were not affected in L. lactis-Mx10-immunized mice. In contrast, mice immunized with L. lactis wild type vector (L. lactis-WT) showed increased neutrophil and monocyte counts and altered histopathology of lymph nodes, lungs and nasal epithelium. Two days after immunization, L. lactis-Mx10-immunized and L. lactis-WT-immunized mice weighed significantly less than unimmunized mice. However, both groups of immunized mice recovered their body weights by Day 6. Our results demonstrate that L. lactis-WT, but not the vaccine L. lactis-Mx10, induces alterations in certain hematologic and histopathological variables. We consider these data a major contribution to data on L. lactis as a bacterial vector for vaccine delivery.


Assuntos
Administração Intranasal/métodos , Antígenos de Bactérias/imunologia , Lactococcus lactis/imunologia , Infecções Estreptocócicas/prevenção & controle , Vacinas Estreptocócicas/imunologia , Streptococcus pyogenes/imunologia , Vacinação/métodos , Vacinas Atenuadas/imunologia , Animais , Anticorpos Antibacterianos/sangue , Antígenos de Bactérias/genética , Autoimunidade/imunologia , Proteínas da Membrana Bacteriana Externa/genética , Proteínas da Membrana Bacteriana Externa/imunologia , Encéfalo/imunologia , Proteínas de Transporte/genética , Proteínas de Transporte/imunologia , Modelos Animais de Doenças , Feminino , Humanos , Imunização , Rim/imunologia , Lactococcus lactis/genética , Pulmão/microbiologia , Pulmão/patologia , Linfonodos/patologia , Camundongos , Camundongos Endogâmicos BALB C , Miocárdio/imunologia , Mucosa Nasal/patologia , Infecções Estreptocócicas/imunologia , Vacinas Estreptocócicas/administração & dosagem , Vacinas Estreptocócicas/genética , Vacinas Estreptocócicas/toxicidade , Streptococcus pyogenes/genética , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/genética
10.
Vaccine ; 36(46): 7033-7042, 2018 11 12.
Artigo em Inglês | MEDLINE | ID: mdl-30293765

RESUMO

BACKGROUND: There is a considerable global burden of invasive group B streptococcal (GBS) disease. Vaccines are being developed for use in pregnant women to offer protection to neonates. OBJECTIVE: To estimate the potential impact and cost-effectiveness of maternal immunisation against neonatal and maternal invasive GBS disease in the UK. METHODS: We developed a decision-tree model encompassing GBS-related events in infants and mothers, following a birth cohort with a time horizon equivalent to average life expectancy (81 years). We parameterised the model using contemporary data from disease surveillance and outcomes in GBS survivors. Costs were taken from NHS sources and research studies. Maternal immunisation in combination with risk-based intrapartum antibiotic prophylaxis (IAP) was compared to the current standard practice of risk-based IAP alone from an NHS and Personal Social Services (health-provider) perspective. We estimated the cases averted and cost per QALY gained through vaccination. One-way sensitivity analysis, scenario analysis and probabilistic sensitivity analysis were performed. RESULTS: An effective maternal immunisation programme could substantially reduce the burden of GBS disease. The deterministic analysis estimated the threshold cost-effective price for a GBS vaccine to be £54 per dose at £20,000/QALY (£71 per dose at £30,000/QALY). Results were most sensitive to assumptions on disease incidence, sequelae rate and vaccine efficacy. Probabilistic analysis showed 90.66% of iterations fell under the £30,000 threshold at a vaccine price of £55. Inclusion of modest prevention of stillbirths and/or, preterm births, carer health impacts, maternal GBS deaths and 1.5% discounting improved cost-effectiveness compared to the base case. Lowering vaccine strain coverage made the vaccine less cost-effective. A key limitation is that the properties of the final GBS vaccine are unknown. CONCLUSIONS: Maternal GBS immunisation is expected to be cost-effective, even at a relatively high vaccine price.


Assuntos
Sepse Neonatal/economia , Sepse Neonatal/prevenção & controle , Infecções Estreptocócicas/economia , Infecções Estreptocócicas/prevenção & controle , Vacinas Estreptocócicas/economia , Vacinas Estreptocócicas/imunologia , Streptococcus agalactiae/imunologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Análise Custo-Benefício , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Pessoa de Meia-Idade , Modelos Estatísticos , Sepse Neonatal/epidemiologia , Gravidez , Infecções Estreptocócicas/epidemiologia , Vacinas Estreptocócicas/administração & dosagem , Reino Unido/epidemiologia , Adulto Jovem
11.
Vaccine ; 36(46): 6968-6978, 2018 11 12.
Artigo em Inglês | MEDLINE | ID: mdl-30340879

RESUMO

BACKGROUND: Group A streptococcus (GAS) causes an exceptionally diverse range of diseases, raising questions about the optimal product characteristics of a commercially viable vaccine. The objectives of this study were to (1) estimate the current health and economic burdens caused by 24 diseases attributable to GAS each year in Australia and (2) use these estimates to explore the value of a GAS vaccine for different clinical indications, age schedules, and population groups. METHODS: For objective 1, we estimated the population heath and economic burdens by synthesising data from administrative databases, nationally representative surveys, literature reviews, public reimbursement schedules, and expert opinion. For objective 2, we modelled the prospective lifetime burden of GAS for all infants from birth, for children from 5 years of age, and for adults from 65 years of age. A vaccine was assumed to reduce each GAS disease by 70% for a period of 10 years, and the difference in outcomes between vaccinated and non-vaccinated cohorts were used to calculate the cost-effective value of vaccination. RESULTS: The annual health and economic burdens of GAS diseases totalled 23,528 disability-adjusted life years and AU$185.1 million in healthcare costs respectively; approximately half of each measure was due to cellulitis, followed by other skin infections and throat infections. Reducing the incidence of throat infections, skin infections, and cellulitis in non-Indigenous cohorts resulted in 30%, 33%, and 28% of the total vaccine value for an infant schedule (cost-effective vaccine price AU$260 per course); 47%, 26%, and 22% of the value for a child schedule (AU$289); and 2%, 15% and 74% for an adult schedule (AU$489). CONCLUSIONS: A vaccine that prevents GAS cellulitis and other skin infections, in addition to throat infections, would maximise its value and commercial viability, with a cost-effective price in line with other recently-licensed and funded vaccines in Australia.


Assuntos
Dermatopatias Bacterianas/economia , Dermatopatias Bacterianas/prevenção & controle , Infecções Estreptocócicas/economia , Infecções Estreptocócicas/prevenção & controle , Vacinas Estreptocócicas/administração & dosagem , Vacinas Estreptocócicas/economia , Streptococcus pyogenes/imunologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Austrália/epidemiologia , Criança , Pré-Escolar , Efeitos Psicossociais da Doença , Custos e Análise de Custo , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Dermatopatias Bacterianas/epidemiologia , Infecções Estreptocócicas/epidemiologia , Adulto Jovem
13.
J Dairy Sci ; 101(11): 10290-10302, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30219416

RESUMO

Streptococcus uberis is a worldwide pathogen that causes intramammary infections in dairy cattle. Nevertheless, commercial vaccines are currently not available and measures to control S. uberis mastitis are limited to the implementation of good management practices. The aim of the present study was to evaluate the efficacy of an S. uberis subunit vaccine against bovine mastitis (Laboratorios Hipra S.A., Amer, Spain) administered precalving against an experimental intramammary challenge with a heterologous S. uberis strain in dairy cows postcalving. With this objective, 25 gestating Holstein-Friesian heifers were randomly assigned to 1 of 2 groups: group 1 (n = 13), vaccinated by intramuscular route with the vaccine, and group 2 (n = 12), vaccinated by intramuscular route with phosphate-buffered saline as a control group. Both groups were immunized 60 and 21 d before the expected parturition date (75 and 36 d before challenge). Fourteen days after calving all cows were challenged by intramammary infusion of 100 colony-forming units of a heterologous S. uberis strain in 2 quarters per cow. Then, challenged quarters were monitored for clinical signs of mastitis, bacterial count, and somatic cell count for the following 21 d. Rectal temperature and daily milk yield per cow were also assessed. Results showed that all challenged quarters developed clinical mastitis. Nevertheless, vaccination significantly reduced the clinical signs of mastitis, bacterial count, rectal temperature, and daily milk yield losses after the intramammary infection and significantly increased the number of quarters with no bacterial isolation and somatic cell count <200,000 cells/mL at the end of the study (d 19, 20, and 21 after challenge). To confirm the efficacy of this vaccine, further studies under field conditions are needed.


Assuntos
Mastite Bovina/prevenção & controle , Leite/microbiologia , Infecções Estreptocócicas/veterinária , Vacinas Estreptocócicas/administração & dosagem , Streptococcus/imunologia , Vacinação/veterinária , Animais , Bovinos , Feminino , Mastite Bovina/microbiologia , Leite/metabolismo , Distribuição Aleatória , Espanha , Infecções Estreptocócicas/microbiologia , Infecções Estreptocócicas/prevenção & controle , Streptococcus/isolamento & purificação
14.
PLoS One ; 13(7): e0198658, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29965967

RESUMO

BACKGROUND: Group A streptococcus (GAS) is a serious human pathogen that affects people of different ages and socio-economic levels. Although vaccination is potentially one of the most effective methods to control GAS infection and its sequelae, few prototype vaccines have been investigated in humans. In this study, we report the safety and immunogenicity of a novel acetylated peptide-protein conjugate vaccine candidate MJ8VAX (J8-DT), when delivered intramuscularly to healthy adults. METHODS: A randomized, double-blinded, controlled Phase I clinical trial was conducted in 10 healthy adult participants. Participants were randomized 4:1 to receive the vaccine candidate (N = 8) or placebo (N = 2). A single dose of the vaccine candidate (MJ8VAX), contained 50 µg of peptide conjugate (J8-DT) adsorbed onto aluminium hydroxide and re-suspended in PBS in a total volume of 0.5 mL. Safety of the vaccine candidate was assessed by monitoring local and systemic adverse reactions following intramuscular administration. The immunogenicity of the vaccine was assessed by measuring the levels of peptide (anti-J8) and toxoid carrier (anti-DT)-specific antibodies in serum samples. RESULTS: No serious adverse events were reported over 12 months of study. A total of 13 adverse events (AEs) were recorded, two of which were assessed to be associated with the vaccine. Both were mild in severity. No local reactogenicity was recorded in any of the participants. MJ8VAX was shown to be immunogenic, with increase in vaccine-specific antibodies in the participants who received the vaccine. The maximum level of vaccine-specific antibodies was detected at 28 days post immunization. The level of these antibodies decreased with time during follow-up. Participants who received the vaccine also had a corresponding increase in anti-DT serum antibodies. CONCLUSIONS: Intramuscular administration of MJ8VAX was demonstrated to be safe and immunogenic. The presence of DT in the vaccine formulation resulted in a boost in the level of anti-DT antibodies. TRIAL REGISTRATION: ACTRN12613000030774.


Assuntos
Infecções Estreptocócicas/tratamento farmacológico , Vacinas Estreptocócicas/administração & dosagem , Vacinação/efeitos adversos , Vacinas Conjugadas/administração & dosagem , Adolescente , Adulto , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infecções Estreptocócicas/imunologia , Infecções Estreptocócicas/microbiologia , Vacinas Estreptocócicas/efeitos adversos , Streptococcus pyogenes/efeitos dos fármacos , Streptococcus pyogenes/patogenicidade , Vacinas Conjugadas/efeitos adversos , Vacinas Conjugadas/imunologia
15.
Expert Rev Vaccines ; 17(7): 635-651, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29961350

RESUMO

INTRODUCTION: Vaccination against group B Streptococcus (GBS) during pregnancy could provide protection against disease in the mother, fetus, and newborn. Immunity through transplacental acquired antibodies in the newborns could persist through early infancy, reducing the risk of early-onset (<7 days age) and late-onset (7-89 days age) disease. We conducted a systematic review of clinical trials on GBS capsular polysaccharide (CPS) vaccine to assess its safety and immunogenicity in pregnant and nonpregnant adults. AREAS COVERED: We searched literature databases PubMed (Medline), Scopus, and the Cochrane library and identified 25 unique records on GBS CPS vaccines with or without conjugant protein. EXPERT COMMENTARY: GBS vaccines were well tolerated, with mild local reactogenicity being the main solicited adverse event and no difference in reporting of other serious adverse events compared to placebo recipients. CPS vaccines conjugated to immunogenic proteins induced ≥fourfold increase of serotype-specific antibodies with high longevity (1-2 years); and capable of promoting homotypic GBS opsonophagocytic killing. Feto-maternal transplacental antibody ratio of serotype-specific IgG ranged between 0.49 and 0.81. The clinical relevance of these immunogenicity studies, however, need to be weighed against a correlate of protection against invasive GBS disease in infants, which is yet to be established using a universally accepted standardized assay.


Assuntos
Complicações Infecciosas na Gravidez/prevenção & controle , Infecções Estreptocócicas/prevenção & controle , Vacinas Estreptocócicas/administração & dosagem , Adulto , Feminino , Humanos , Imunogenicidade da Vacina , Lactente , Recém-Nascido , Doenças do Recém-Nascido/microbiologia , Doenças do Recém-Nascido/prevenção & controle , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Gravidez , Complicações Infecciosas na Gravidez/imunologia , Complicações Infecciosas na Gravidez/microbiologia , Infecções Estreptocócicas/imunologia , Vacinas Estreptocócicas/efeitos adversos , Vacinas Estreptocócicas/imunologia , Streptococcus agalactiae/imunologia , Streptococcus agalactiae/isolamento & purificação , Fatores de Tempo
16.
PLoS One ; 13(5): e0196564, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29727446

RESUMO

Streptococcus agalactiae, or group B streptococcus (GBS), is an important pathogen as it is the leading cause of neonatal deaths due to sepsis, meningitis or bacterial pneumonia. Although the development of an effective and safe GBS vaccine is on the agenda of many research labs, there is no GBS vaccine on the market yet. In the present study we attempted to engineer a live vaccine strain based on Bac, a surface protein of GBS, incorporated into a surface fimbrial protein of probiotic Enterococcus. The resulting strain induced specific systemic and local immune responses in mice and provided protection against GBS when administered via the intranasal, oral or intravaginal immunization routes.


Assuntos
Imunidade nas Mucosas , Infecções Estreptocócicas/imunologia , Infecções Estreptocócicas/prevenção & controle , Vacinas Estreptocócicas/imunologia , Streptococcus agalactiae/imunologia , Streptococcus agalactiae/patogenicidade , Administração Intranasal , Administração Intravaginal , Administração Oral , Animais , Anticorpos Antibacterianos/biossíntese , Anticorpos Antibacterianos/sangue , Carga Bacteriana , Proteínas de Bactérias/genética , Proteínas de Bactérias/imunologia , Enterococcus faecium/genética , Enterococcus faecium/imunologia , Feminino , Proteínas de Fímbrias/genética , Proteínas de Fímbrias/imunologia , Camundongos , Probióticos , Infecções Estreptocócicas/microbiologia , Vacinas Estreptocócicas/administração & dosagem , Vacinas Estreptocócicas/genética , Streptococcus agalactiae/genética , Vacinas Conjugadas/administração & dosagem , Vacinas Conjugadas/genética , Vacinas Conjugadas/imunologia , Vacinas Sintéticas/administração & dosagem , Vacinas Sintéticas/genética , Vacinas Sintéticas/imunologia
17.
PLoS One ; 13(5): e0195450, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29847601

RESUMO

Streptococcus iniae is a major Gram-positive pathogen that causes invasive disease in fish worldwide. In this study, in order to identify immunogenic proteins for developing highly effective vaccine against S. iniae, whole-cell lysate proteins of S. iniae were analyzed by western blotting using flounder anti-S. iniae antibodies, and two positive protein bands of molecular weight 37 kDa and 40 kDa were screened, which were identified as pyruvate dehydrogenase E1 subunit alpha (PDHA1), BMP family ABC transporter substrate-binding protein (BMP) and L-lactate dehydrogenase (LDH), as well as ornithine carbamoyltransferase (OCT), lactate oxidas (LOx) and glyceraldehyde-3-phosphate dehydrogenase (GAPDH) by mass spectrometry. Subsequently, the six recombinant proteins were produced and used to immunize healthy flounder, and the relative percent survival (RPS) value was 72.73%, 27.27%, 36.36%, 9.09%, 36.36% and 63.64% respectively after intraperitoneal challenge with live S. iniae, revealing that rPDHA1 and rGAPDH produced higher relative percent survival than formalin-killed S. iniae (36.36%). To further investigate the protective efficacy of rPDHA1 and rGAPDH, the proliferation of surface membrane immunoglobulin-positive (sIg+) lymphocytes in peripheral blood leucocytes, the total serum IgM, specific IgM against S. iniae and RPS were detected. The results showed that rPDHA1, rGAPDH and formalin-killed S. iniae significantly induced the proliferation of sIg+ lymphocytes, the production of total serum IgM and specific IgM as compared with the control group, and rGAPDH and rPDHA1 provide higher RPS (62.5% and 75%, respectively) again. These results demonstrated that rPDHA1 and rGAPDH are promising vaccine candidates against S. iniae infection in flounder.


Assuntos
Doenças dos Peixes/imunologia , Linguado/imunologia , Gliceraldeído-3-Fosfato Desidrogenases/imunologia , Piruvato Desidrogenase (Lipoamida)/imunologia , Proteínas Recombinantes/imunologia , Infecções Estreptocócicas/imunologia , Streptococcus iniae/imunologia , Animais , Anticorpos Antibacterianos/imunologia , Doenças dos Peixes/prevenção & controle , Linguado/microbiologia , Infecções Estreptocócicas/microbiologia , Infecções Estreptocócicas/prevenção & controle , Vacinas Estreptocócicas/administração & dosagem , Vacinas Estreptocócicas/imunologia , Vacinação
18.
Fish Shellfish Immunol ; 79: 181-192, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29684601

RESUMO

Dissolved oxygen (DO) and temperature are the potential immunomodulators in fish and play the important roles in regulating immunity. We studied the effect of intermittent hypoxia under different temperature on the immunomodulation in vaccinated Nile tilapia (Oreochromis niloticus). The expression of immune-related genes, enzymatic activities, histology, cumulative mortality, and S. agalactiae clearance were assessed. Study conditions were intermittently hypoxic (4.0 ±â€¯1.0 mg/L DO) at 30 ±â€¯0.5 °C or 35 ±â€¯0.5 °C. Interleukin-1beta (IL-1ß), tumor necrosis factor alpha (TNF-α) and gamma interferon (IFN-γ) mRNA expression in spleen and head kidney were significantly lower in vaccinated hypoxic fish compared to the vaccinated normoxic fish. Levels of heat shock protein 70 (HSP70) in tissues showed an opposite tendency. Superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GSH-Px) activities were significantly lower in vaccinated hypoxic fish. Malondialdehyde levels were significantly greater under hypoxic conditions. In vitro studies evaluated the effects of intermittent hypoxia at different temperatures on cells of vaccinated O. niloticus. Phagocytic activity of peripheral blood leucocytes (PBLs) and intracellular reactive oxygen species (ROS) production in head kidney cells were significantly decreased by intermittent hypoxia at either 30 °C or 35 °C, while nitric oxide levels in tissues cells increased significantly under hypoxic conditions. These changes were well reflected by the further suppression modulation on S. agalactiae clearance in vaccinated O. niloticus and higher cumulative mortality by intermittent hypoxia. Taken together, intermittent hypoxia at either 30 °C or 35 °C could suppress immunomodulation in vaccinated Nile tilapia.


Assuntos
Hipóxia Celular/imunologia , Ciclídeos , Doenças dos Peixes/imunologia , Imunomodulação , Infecções Estreptocócicas/veterinária , Vacinas Estreptocócicas/administração & dosagem , Streptococcus agalactiae/imunologia , Anaerobiose , Animais , Derrame de Bactérias , Doenças dos Peixes/prevenção & controle , Proteínas de Peixes/genética , Expressão Gênica/imunologia , Infecções Estreptocócicas/imunologia , Infecções Estreptocócicas/prevenção & controle , Temperatura
19.
Microbiol Immunol ; 62(6): 395-404, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29704396

RESUMO

Streptococcus pyogenes (group A Streptococcus) causes diseases ranging from mild pharyngitis to severe invasive infections. The N-terminal fragment of streptococcal M protein elicits protective antibodies and is an attractive vaccine target. However, this N- terminal fragment is hypervariable: there are more than 200 different M types. In this study, an intranasal live bacterial vaccine comprising 10 strains of Lactococcus lactis, each expressing one N-terminal fragment of M protein, has been developed. Live bacterial-vectored vaccines cost less to manufacture because the processes involved are less complex than those required for production of protein subunit vaccines. Moreover, intranasal administration does not require syringes or specialized personnel. Evaluation of individual vaccine types (M1, M2, M3, M4, M6, M9, M12, M22, M28 and M77) showed that most of them protected mice against challenge with virulent S. pyogenes. All 10 strains combined in a 10-valent vaccine (M×10) induced serum and bronchoalveolar lavage IgG titers that ranged from three- to 10-fold those of unimmunized mice. After intranasal challenge with M28 streptococci, survival of M×10-immunized mice was significantly higher than that of unimmunized mice. In contrast, when mice were challenged with M75 streptococci, survival of M×10-immunized mice did not differ significantly from that of unimmunized mice. Mx-10 immunized mice had significantly less S. pyogenes in oropharyngeal washes and developed less severe disease symptoms after challenge than did unimmunized mice. Our L. lactis-based vaccine may provide an alternative solution to development of broadly protective group A streptococcal vaccines.


Assuntos
Administração Intranasal/métodos , Antígenos de Bactérias/imunologia , Proteínas da Membrana Bacteriana Externa/imunologia , Proteínas de Transporte/imunologia , Lactococcus lactis/imunologia , Infecções Estreptocócicas/prevenção & controle , Vacinas Estreptocócicas/imunologia , Streptococcus pyogenes/imunologia , Vacinação/métodos , Vacinas Atenuadas/imunologia , Animais , Anticorpos Antibacterianos/sangue , Antígenos de Bactérias/classificação , Antígenos de Bactérias/metabolismo , Proteínas da Membrana Bacteriana Externa/classificação , Proteínas da Membrana Bacteriana Externa/metabolismo , Peso Corporal , Proteínas de Transporte/classificação , Proteínas de Transporte/metabolismo , Modelos Animais de Doenças , Feminino , Imunidade , Imunização , Imunoglobulina G/sangue , Lactococcus lactis/patogenicidade , Camundongos , Camundongos Endogâmicos BALB C , Infecções Estreptocócicas/imunologia , Infecções Estreptocócicas/microbiologia , Vacinas Estreptocócicas/administração & dosagem , Resultado do Tratamento , Vacinas Atenuadas/administração & dosagem , Vacinas Sintéticas/administração & dosagem , Vacinas Sintéticas/imunologia
20.
Vet Rec ; 182(11): 316-318, 2018 03 17.
Artigo em Inglês | MEDLINE | ID: mdl-29545493
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