Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 17.659
Filtrar
2.
J Infect Dis ; 223(2): 189-191, 2021 02 03.
Artículo en Inglés | MEDLINE | ID: mdl-33535239

RESUMEN

Developers of severe acute respiratory syndrome coronavirus 2 vaccines should consider some of the lessons from a "new" vaccine introduced in 1921, namely bacille Calmette-Guérin.


Asunto(s)
Vacuna BCG/inmunología , /prevención & control , /inmunología , Animales , Vacuna BCG/administración & dosificación , /virología , Humanos , Pandemias/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , Tuberculosis/inmunología , Tuberculosis/prevención & control
3.
Medicine (Baltimore) ; 100(7): e24796, 2021 Feb 19.
Artículo en Inglés | MEDLINE | ID: mdl-33607839

RESUMEN

RATIONAL: Bacillus Calmette-Guérin (BCG) intravesical instillation therapy is a widely used treatment for bladder cancer; however, an infectious aneurysm has been reported as a rare complication. PATIENT CONCERNS: A 76-year-old man who underwent BCG intravesical instillation therapy for bladder cancer presented with prolonged dull back pain for 3 months. DIAGNOSIS: Computed tomography (CT) revealed both thoracic and abdominal aortic aneurysms (AAAs). Follow-up CT at 4 weeks after the initial examination showed rapid enlargement of both aneurysms and typical findings of inflammation. Therefore, he was diagnosed with an impending rupture of infectious aneurysms. INTERVENTIONS: Although open surgical resection of both aneurysms and vascular reconstruction were ideal, these operations were considered highly invasive for the patient. Therefore, a hybrid operation consisting of simultaneous endovascular repair of the thoracic aneurysm and open surgery of the abdominal lesion was performed. OUTCOMES: BCG "Tokyo-172" strain was identified in the resected sample from the aneurysmal wall, and he continued to receive oral antituberculosis drugs for 6 months. No sign of recurrent infection was observed 1 year after the operation. LESSONS: A hybrid operation might be justified as an alternative to the conventional open surgical procedure, especially for patients with infectious aneurysms caused by weak pathogenic bacteria such as, the BCG mycobacteria.


Asunto(s)
Aneurisma Infectado/etiología , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/cirugía , Vacuna BCG/efectos adversos , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Administración Intravesical , Anciano , Aneurisma Infectado/microbiología , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/microbiología , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/microbiología , Vacuna BCG/administración & dosificación , Humanos , Masculino , Mycobacterium/aislamiento & purificación , Tomografía Computarizada por Rayos X
4.
Allergol Immunopathol (Madr) ; 49(1): 168-169, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33528947
5.
Orv Hetil ; 162(4): 123-134, 2021 01 24.
Artículo en Húngaro | MEDLINE | ID: mdl-33486464

RESUMEN

Összefoglaló. Bevezetés: A COVID-19-járvány az egész világon elterjedt. A járvány Európában való elso megjelenése során megfigyelheto volt, hogy a terjedés mértéke kisebb azokban az országokban, ahol a tuberkulózis elleni védekezésül kiterjedt BCG-vakcinációt végeznek. Célkituzés: A jelen munkában olyan összefüggéseket igyekeztünk feltárni, amelyek befolyásolták a járványterjedés paramétereit, különös figyelemmel a BCG-vakcinációs gyakorlatra. Módszerek: A világ összes olyan országára vonatkozóan, ahol megfelelo minoségu statisztikai adatok álltak rendelkezésünkre, vizsgáltuk a járvány terjedésének elso hullámát. A mozgóátlagolt járványgörbéken elemeztük a járvány idotartamát, a tetozés mértékét, a fertozöttek és a halálesetek egymillió lakosra vetített számát. Figyelembe vettük az országok gazdasági mutatóit (GDP, légi forgalom, a tengeri hajózás mértéke). Statisztikai analízis: A vizsgált paraméterek nem mutattak normális eloszlást, így nemparaméteres próbákkal (rangkorreláció, Kruskal-Wallis ANOVA) statisztikai kapcsolatot kerestünk a járványterjedés mértéke, a BCG-vakcináció és más paraméterek között. Eredmények: A járvány gyorsan elterjedt a világon, de mégis, február elso három hetében a terjedésben egy szünet volt megfigyelheto. A járványhullám Európában nagyjából egyszerre ért véget. A járvány által leginkább azok az országok érintettek, ahol nem alkalmaztak rendszeres BCG-vakcinációt, bár a képet bonyolítja, hogy ezek az országok gazdaságilag többnyire fejlettek. A halálozási rátában nem mutatkozott ilyen különbség. Következtetés: Statisztikailag igazolható tény, hogy a vakcinációt végzo országokból az elso hullám alatt kevesebb fertozöttet jelentettek; az ok-okozati összefüggés bizonytalan, hiszen az országok múltja, szokásai, társadalmi berendezkedése, gazdasági fejlettsége nem azonos. Eredményeink alátámasztják az összehasonlító kontaktkutatás fontosságát annak tisztázására, hogy a BCG-oltás hogyan befolyásolja az emberek vírussal szembeni érzékenységét, valamint a vírus terjesztésének, továbbadásának képességét. Orv Hetil. 2021; 162(4): 123-134. INTRODUCTION: The new type of coronavirus (SARS-CoV-2) epidemic is widespread throughout the world. During the outbreak of the pandemic in Europe it was revealed that the rate of spread was lower in countries where extensive BCG vaccination is used to protect against tuberculosis. OBJECTIVE: In the present work, we sought to explore relationships that influenced epidemic spreading parameters, with particular reference to BCG vaccination practice. METHODS: We examined the first wave of the spread of the epidemic for all countries in the world where adequate quality statistics were available. We analyzed the duration of the epidemic, the extent of the peak, the number of infected people, and the number of deaths per million inhabitants with the moving average of epidemic curves. We took into account the economic indicators of the countries (GDP, air traffic and extent of maritime shipping). STATISTICAL ANALYSIS: The examined parameters did not show a normal distribution, so we looked for a statistical relationship with non-parametric tests (rank correlation, Kruskal-Wallis ANOVA) between the extents of epidemic spread, BCG vaccination and other parameters. RESULTS: The epidemic spread rapidly around the world, but still, in the first three weeks of February, there was a pause in the spread. The first wave of epidemics ended roughly at the same time in Europe. Those countries are the most affected by the epidemic where regular BCG vaccination has not been used, although the picture is complicated by the fact that these countries are mostly economically developed. There was no such difference observable in the mortality rate. CONCLUSION: Although this work clearly demonstrates that during the first wave of the pandemic, fewer infections were reported worldwide in countries where BCG vaccination is obligatory, however, the causal relationship is uncertain, as the countries' past, customs, social organization and economic development are different. Our results support the necessity of comparative contact tracing to clarify how BCG vaccination affects people's susceptibility to this new type of coronavirus as well as their ability to spread and transmit the virus. Orv Hetil. 2021; 162(4): 123-134.


Asunto(s)
Vacuna BCG/uso terapéutico , Pandemias , Salud Global , Humanos
6.
Sci Rep ; 11(1): 774, 2021 01 12.
Artículo en Inglés | MEDLINE | ID: mdl-33436946

RESUMEN

Population-level data have suggested that bacille Calmette-Guerin (BCG) vaccination may lessen the severity of Coronavirus Disease-19 (COVID-19) prompting clinical trials in this area. Some reports have demonstrated conflicting results. We performed a robust, ecologic analysis comparing COVID-19 related mortality (CRM) between strictly selected countries based on BCG vaccination program status utilizing publicly available databases and machine learning methods to define the association between active BCG vaccination programs and CRM. Validation was performed using linear regression and country-specific modeling. CRM was lower for the majority of countries with a BCG vaccination policy for at least the preceding 15 years (BCG15). CRM increased significantly for each increase in the percent population over age 65. A higher total population of a country and BCG15 were significantly associated with improved CRM. There was a consistent association between countries with a BCG vaccination for the preceding 15 years, but not other vaccination programs, and CRM. BCG vaccination programs continued to be associated with decreased CRM even for populations < 40 years old where CRM events are less frequent.


Asunto(s)
Vacuna BCG/uso terapéutico , Vacunación/estadística & datos numéricos , /epidemiología , Europa (Continente) , Humanos , República de Corea , Aprendizaje Automático no Supervisado
7.
Proc Natl Acad Sci U S A ; 118(4)2021 01 26.
Artículo en Inglés | MEDLINE | ID: mdl-33468674

RESUMEN

The global incidence of tuberculosis remains unacceptably high, with new preventative strategies needed to reduce the burden of disease. We describe here a method for the generation of synthetic self-adjuvanted protein vaccines and demonstrate application in vaccination against Mycobacterium tuberculosis Two vaccine constructs were designed, consisting of full-length ESAT6 protein fused to the TLR2-targeting adjuvants Pam2Cys-SK4 or Pam3Cys-SK4 These were produced by chemical synthesis using a peptide ligation strategy. The synthetic self-adjuvanting vaccines generated powerful local CD4+ T cell responses against ESAT6 and provided significant protection in the lungs from virulent M. tuberculosis aerosol challenge when administered to the pulmonary mucosa of mice. The flexible synthetic platform we describe, which allows incorporation of adjuvants to multiantigenic vaccines, represents a general approach that can be applied to rapidly assess vaccination strategies in preclinical models for a range of diseases, including against novel pandemic pathogens such as SARS-CoV-2.


Asunto(s)
Mycobacterium tuberculosis/inmunología , Vacunas contra la Tuberculosis/farmacología , Tuberculosis/inmunología , Tuberculosis/prevención & control , Vacunas Conjugadas/farmacología , Adyuvantes Inmunológicos/farmacología , Animales , Antígenos Bacterianos/inmunología , Vacuna BCG/inmunología , Vacuna BCG/farmacología , Proteínas Bacterianas , Linfocitos T CD4-Positivos/inmunología , Modelos Animales de Enfermedad , Femenino , Ratones , Ratones Endogámicos C57BL , Receptor Toll-Like 2/inmunología , Vacunas contra la Tuberculosis/inmunología , Vacunas Conjugadas/inmunología , Vacunas Sintéticas/inmunología , Vacunas Sintéticas/farmacología
8.
Immunobiology ; 226(1): 152052, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33418320

RESUMEN

The century-old tuberculosis vaccine BCG has been the focus of renewed interest due to its well-documented ability to protect against various non-TB pathogens. Much of these broad spectrum protective effects are attributed to trained immunity, the epigenetic and metabolic reprogramming of innate immune cells. As BCG vaccine is safe, cheap, widely available, amendable to use as a recombinant vector, and immunogenic, it has immense potential for use as an immunotherapeutic agent for various conditions including autoimmune, allergic, neurodegenerative, and neoplastic diseases as well as a preventive measure against infectious agents. Of particular interest is the use of BCG vaccination to counteract the increasing prevalence of autoimmune and allergic conditions in industrialized countries attributable to reduced infectious burden as described by the 'hygiene hypothesis.' Furthermore, BCG vaccination has been proposed as a potential therapy to mitigate spread and disease burden of COVID-19 as a bridge to development of a specific vaccine and recombinant BCG expression vectors may prove useful for the introduction of SARS-CoV-2 antigens (rBCG-SARS-CoV-2) to induce long-term immunity. Understanding the immunomodulatory effects of BCG vaccine in these disease contexts is therefore critical. To that end, we review here BCG-induced immunomodulation focusing specifically on BCG-induced trained immunity and how it relates to the 'hygiene hypothesis' and COVID-19.


Asunto(s)
Vacuna BCG/inmunología , Vacuna BCG/uso terapéutico , /terapia , Hipótesis de la Higiene , Inmunidad Innata , /virología , Humanos , Inmunomodulación
9.
J Formos Med Assoc ; 120(1 Pt 2): 443-451, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-32553527

RESUMEN

PURPOSE: To investigate the clinical feature of tuberculosis and BCG adverse effects in children and to examine whether delayed BCG vaccination changes the incidence of BCG osteomyelitis. METHODS: We analyzed patients younger than 18 years with tuberculosis or BCG-associated adverse effects from 2008 to 2019. We compared their clinical features, laboratory tests and outcomes. RESULTS: Totally 137 patients were collected, with 27% of pulmonary tuberculosis (PTB), 31% of extrapulmonary tuberculosis (EPTB) and 42% of BCG-associated adverse effects. The median age was older in PTB than EPTB group (17.1 vs 15.4 years; p = 0.015). More patients in EPTB group had fever than PTB group (55% vs 25%; p = 0.008). Compared with exclusively EPTB, more patients in EPTB plus PTB group had fever (78% vs 38%; p = 0.009), and had more systemic symptoms (67% vs 25%; p = 0.007), lower absolute lymphocyte count (1230 vs 1850/µL; p = 0.033), higher CRP level (5.62 vs 2.21 mg/dL; p = 0.024) and longer hospital stay (20 vs 11 days; p = 0.031). In BCG osteomyelitis group, the median time interval from vaccination to diagnosis was 16.4 months (IQR 15.0-20.2). Age at vaccination, either at birth or 5-8 month-old, did not affect the proportion of BCG osteomyelitis among children with BCG-associated adverse effects. CONCLUSION: Children with EPTB plus PTB had more fever, lower lymphocyte count and higher CRP. The median time interval from vaccination to diagnosis of BCG osteomyelitis was 16.4 months and the proportion of BCG osteomyelitis among children with BCG-associated adverse effects was not affected by delayed vaccination in this study.


Asunto(s)
Vacuna BCG/efectos adversos , Tuberculosis Pulmonar , Tuberculosis , Adolescente , Niño , Humanos , Incidencia , Lactante , Tuberculosis/epidemiología , Vacunación/efectos adversos
10.
Vaccine ; 39(3): 460-462, 2021 01 15.
Artículo en Inglés | MEDLINE | ID: mdl-33341305

RESUMEN

Bacille Calmette-Guérin (BCG) vaccine is proven to be effective in protecting against severe tuberculosis. It has been suggested to be able to exert a non-specific beneficial effect as protection against other infectious diseases. The duration of protection against tuberculosis is estimated to be from 10 to 15 years, but the duration of the protection against other infections is not known, maybe up to 20 years, maybe much shorter than that. We don't know it for sure. BCG induced trained immunity paradigm is based on experimental models, cohort studies with low number of individuals, and some epidemiological data in which other possible interfering factors are not controlled. The titles and scopes of scientific articles should be cautiously considered as they can promote indications of getting vaccinated or revaccinated with BCG, before its effectiveness is confirmed and recommendations are published. Besides, revaccination with BCG can put at serious risk patients with primary or secondary immunodeficiency. Maybe BCG vaccine is effective in preventing COVID-19 deaths or reducing its severity, but may the effect of this vaccine be relevant even with poor health politics and assistance? It is very difficult to compare the epidemiologic data about COVID-19 in different countries. There are countless factors, mainly social and related to the healthcare system, which can be more decisive than the hypothesis of trained immunity induced by BCG. Until now, we can say that BCG's protective role is, at least, insufficient, given many other factors that corroborate SARS-CoV-2 infection and/or its severity.


Asunto(s)
Tuberculosis , Vacuna BCG , Humanos , Inmunización Secundaria , Tuberculosis/prevención & control
11.
Ned Tijdschr Geneeskd ; 1642020 10 07.
Artículo en Holandés | MEDLINE | ID: mdl-33331729

RESUMEN

A number of clinical trials are currently underway worldwide to assess whether BCG, the old vaccine against tuberculosis, can protect against COVID-19 infection. In this Perspective, we briefly outline the background, the immunological mechanisms (in particular induction of 'innate immune memory' or 'trained immunity'), and further considerations for the potential future use of BCG against viral and other infections.


Asunto(s)
Vacuna BCG , Reposicionamiento de Medicamentos/métodos , Memoria Inmunológica/inmunología , Tuberculosis/prevención & control , Vacuna BCG/inmunología , Vacuna BCG/uso terapéutico , /prevención & control , Humanos , Inmunidad Innata/inmunología , Tuberculosis/inmunología
12.
BMJ Case Rep ; 13(12)2020 Dec 17.
Artículo en Inglés | MEDLINE | ID: mdl-33334773

RESUMEN

The aetiology of febrile exanthems in children is often difficult to distinguish clinically. A diagnosis of Kawasaki disease (KD) should be considered in infants with exanthematous fever. More perplexing is the increasing incidence of an atypical form of KD. Pathogenesis of KD remains unclear even though an aberrant response of the immune system to an unidentified pathogen is often hypothesised. A 30-fold increase in the incidence of KD in Italy during the SARS-CoV-2 pandemic suggests an immune response to a viral trigger. We report an infant clinically diagnosed with high probability as incomplete KD, who presented with reactivation of the BCG injection site even though fever with rash was only less than 3 days duration. Echocardiography confirmed coronary artery abnormalities and prompt treatment with intravenous immunoglobulin facilitated rapid recovery. Physicians should consider a diagnosis of KD if BCG site reactivation is noted in children presenting with febrile exanthema.


Asunto(s)
Exantema/etiología , Síndrome Mucocutáneo Linfonodular/complicaciones , Síndrome Mucocutáneo Linfonodular/diagnóstico , Vacuna BCG/administración & dosificación , Fiebre , Humanos , Factores Inmunológicos/uso terapéutico , Lactante , Masculino , Síndrome Mucocutáneo Linfonodular/tratamiento farmacológico , Vacunación/efectos adversos , gammaglobulinas/uso terapéutico
14.
PLoS One ; 15(12): e0243707, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33332418

RESUMEN

As the SARS-CoV2 pandemic has progressed, there have been marked geographical differences in the pace and extent of its spread. We evaluated the association of BCG vaccination on morbidity and mortality of SARS-CoV2, adjusted for country-specific responses to the epidemic, demographics and health. SARS-CoV2 cases and deaths as reported by 31 May 2020 in the World Health Organization situation reports were used. Countries with at least 28 days following the first 100 cases, and available information on BCG were included. We used log-linear regression models to explore associations of cases and deaths with the BCG vaccination policy in each country, adjusted for population size, gross domestic product, proportion aged over 65 years, stringency level measures, testing levels, smoking proportion, and the time difference from date of reporting the 100th case to 31 May 2020. We further looked at the association that might have been found if the analyses were done at earlier time points. The study included 97 countries with 73 having a policy of current BCG vaccination, 13 having previously had BCG vaccination, and 11 having never had BCG vaccination. In a log-linear regression model there was no effect of country-level BCG status on SARS-CoV2 cases or deaths. Univariable log-linear regression models showed a trend towards a weakening of the association over time. We found no statistical evidence for an association between BCG vaccination policy and either SARS-CoV2 morbidity or mortality. We urge countries to rather consider alternative tools with evidence supporting their effectiveness for controlling SARS-CoV2 morbidity and mortality.


Asunto(s)
Vacuna BCG/administración & dosificación , Modelos Biológicos , Pandemias , Vacunación , Adulto , Anciano , /transmisión , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad
15.
Pan Afr Med J ; 35(Suppl 2): 131, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33193946

RESUMEN

Introduction: Nigeria is the most populous country in the African continent. The aim of this study was to analyze risk factors for COVID-19 prevalence and deaths in all 6 geopolitical regions and 37 States in Nigeria. Methods: we analyzed the data retrieved from various sources, including Nigeria CDC, Nigeria National Bureau of Statistics, Unicef-Nigeria multiple indicator cluster survey and the Institute of Health Metrics and Evaluation, University of Washington. We examined 4 clinical risk factors (prevalence of TB, HIV, smoking and BCG vaccination coverage) and 5 sociodemographic factors (age ≥65, population density, literacy rate, unemployment and GDP per capita). Multivariate modeling was conducted using generalized linear model. Results: our analysis showed that the incidence of confirmed COVID-19 cases differed widely across the 37 States, from 0.09 per 100,000 in Kogi to 83.7 in Lagos. However, more than 70% of confirmed cases were concentrated in just 7 States: Lagos, Abuja, Oyo, Kano, Edo, Rivers and Delta. Case mortality rate (CMR) also varied considerably, with Lagos, Abuja and Edo having CMR above 9 per million population. On bivariate analysis, higher CMR correlated positively with GDP (r=0.53) and to a lesser extent with TB (r=0.36) and population density (r=0.38). On multivariate analysis, which is more definitive, States with higher HIV prevalence and BCG coverage had lower CMR, while high GDP States had a greater CMR. Conclusion: this study indicates that COVID-19 has disproportionately affected certain States in Nigeria. Population susceptibility factors include higher economic development but not literacy or unemployment. Death rates were mildly lower in States with higher HIV prevalence and BCG vaccination coverage.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/mortalidad , Pandemias , Neumonía Viral/mortalidad , Factores de Edad , Anciano , Vacuna BCG , Femenino , Geografía Médica , Producto Interno Bruto/estadística & datos numéricos , Infecciones por VIH/epidemiología , Humanos , Alfabetización/estadística & datos numéricos , Masculino , Nigeria/epidemiología , Densidad de Población , Prevalencia , Utilización de Procedimientos y Técnicas , Factores de Riesgo , Fumar/epidemiología , Determinantes Sociales de la Salud , Tuberculosis/epidemiología , Desempleo/estadística & datos numéricos , Vacunación/estadística & datos numéricos
16.
Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi ; 36(11): 1044-1048, 2020 Nov.
Artículo en Chino | MEDLINE | ID: mdl-33210600

RESUMEN

The research and development of the coronavirus disease 2019 (COVID-19) vaccine is being carried out globally. Although vaccine research and development technology has made great progress, the possibility of obtaining a safe and effective vaccine that can control the global epidemic in a short period of time is still low due to the antibody-dependent enhancement effect (ADE) of the vaccine and the mutation of the virus. In the absence of specific treatment for COVID-19, finding other alternative protection schemes has become another treatment idea. Epidemiological studies have found that, in this COVID-19 epidemic, countries with long-term Bacillus Calmette-Guerin (BCG) vaccination policies have relatively less cases and lower mortality rates than countries without relevant policies. This phenomenon may be related to the "training immunity" effect of BCG. In order to further clarify the preventive and protective effects of BCG vaccine on SARS-CoV-2 infection, a number of clinical trials are underway.


Asunto(s)
Vacuna BCG/uso terapéutico , Infecciones por Coronavirus/prevención & control , Pandemias/prevención & control , Neumonía Viral/prevención & control , Betacoronavirus , Ensayos Clínicos como Asunto , Humanos
17.
Rev Soc Bras Med Trop ; 53: e20200504, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33174962

RESUMEN

Coronavirus disease 2019 (COVID-19) was first officially described in Brazil on February 26th, 2020. The accumulation of reports of concomitant infections with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and pathogens that cause diseases endemic to tropical countries, such as dengue and chikungunya fever, has started to draw attention. Chagas disease and leprosy remain public health problems in many developing countries, such as Brazil. In this manuscript, we describe a case of concomitant leprosy, Chagas disease, and COVID-19, highlighting the cutaneous manifestations of SARS-CoV-2 infection and the clinical behavior of household contacts who previously received prophylactic Bacillus Calmette-Guérin vaccines.


Asunto(s)
Enfermedad de Chagas/complicaciones , Infecciones por Coronavirus/complicaciones , Lepra Dimorfa/complicaciones , Neumonía Viral/complicaciones , Vacuna BCG/administración & dosificación , Betacoronavirus , Brasil , Composición Familiar , Humanos , Pandemias
18.
Actas urol. esp ; 44(9): 574-585, nov. 2020. ilus, tab
Artículo en Español | IBECS | ID: ibc-ET6-1327

RESUMEN

CONTEXTO: El tratamiento estándar de los tumores de vejiga no músculo-invasivos (TVNMI) de alto riesgo es la resección transuretral de vejiga e instilaciones de bacilo de Calmette-Guérin (BCG). Sin embargo, las respuestas son limitadas. Es necesario buscar nuevas alternativas terapéuticas para estos pacientes. Los resultados en tumores avanzados de los inhibidores de puntos de control han dado lugar al interés en el uso de estas moléculas en TVNMI. MÉTODOS: Hemos realizado una búsqueda en PubMed utilizando los términos «bladder cancer» y «check point inhibitors». Para la búsqueda de ensayos clínicos, hemos utilizado los buscadores clinicaltrials.gov y clinicaltrialsregister.eu RESULTADOS: Actualmente hay 5 ensayos en marcha de pacientes no tratados con BCG. No hay resultados disponibles. En cuanto a los pacientes no respondedores a BCG, existen 15 ensayos en marcha, 2 de ellos con resultados preliminares: el Keynote 057, con resultados prometedores con pembrolizumab y que ha llevado a la FDA a aprobar su uso en enero de 2020 y el SWOG S1605, que ha mostrado resultados similares con atezolizumab. Otros ensayos administran estos fármacos intravesicalmente, una opción atractiva si resulta efectiva para el control oncológico. CONCLUSIONES: Los inhibidores de puntos de control ofrecen una nueva posibilidad para los pacientes no respondedores al BCG. Probablemente en el futuro se podrán usar en pacientes no tratados previamente con BCG. Los datos preliminares de ensayos clínicos muestran resultados prometedores. Es importante un buen conocimiento de estas moléculas por los urólogos y la formación de equipos multidisciplinares para ofrecer las mejores alternativas terapéuticas a estos pacientes


BACKGROUND: The standard treatment for high-risk non-muscle invasive bladder tumors (NMIBT) is transurethral resection of the bladder and BCG instillations. However, responses are limited, and new therapeutic alternatives for these patients are required. The results of checkpoint inhibitors in advanced tumors have led to interest in the use of these molecules in NMIBT. METHODS: We conducted a search on PubMed using the terms «bladder cancer» and «check point inhibitors». We have used the search engines clinicaltrials.gov and clinicaltrialsregister.eu for the search of clinical trials. RESULTS: There are currently 5 trials in progress on BCG untreated patients. There are no results available. As for BCG non-responders, there are 15 ongoing trials, two of them with preliminary results: Keynote 057, with promising results with pembrolizumab, which has led the FDA to approve its use in January 2020, and SWOG S1605, which has shown similar results with atezolizumab. Other trials are using intravesical administration of these drugs, which is an attractive option if it is effective for cancer control. CONCLUSIONS: Checkpoint inhibitors offer a new possibility for patients who do not respond to BCG. These will probably be used in the future for previously BCG untreated patients. Preliminary data from clinical trials show promising results. A good understanding of these molecules by urologists and the creation of multidisciplinary teams are crucial in order to offer the best therapeutic alternatives to these patients


Asunto(s)
Humanos , Neoplasias de la Vejiga Urinaria/terapia , Antineoplásicos Inmunológicos/uso terapéutico , Inmunoterapia/métodos , Receptor de Muerte Celular Programada 1/antagonistas & inhibidores , Factores de Riesgo , Vacuna BCG/uso terapéutico , Resultado del Tratamiento
19.
Recurso de Internet en Portugués | LIS - Localizador de Información en Salud | ID: lis-47940

RESUMEN

A Fiocruz inicia, nesta segunda-feira (19/10), o Brace Trial Brasil (BTB), estudo com a vacina BCG que visa reduzir o impacto do Covid-19 em trabalhadores de saúde. O recrutamento dos voluntários será realizado na Faculdade de Medicina da Universidade Federal do Mato Grosso do Sul (UFMS) e os interessados devem realizar pré-cadastro pela internet.


Asunto(s)
Infecciones por Coronavirus , Vacuna BCG/inmunología , Investigación
20.
Trials ; 21(1): 881, 2020 Oct 26.
Artículo en Inglés | MEDLINE | ID: mdl-33106170

RESUMEN

OBJECTIVES: The BCG vaccine, widely used in Brazil in new-borns, induces adjuvant protection for several diseases, including childhood virus infections. BCG activates monocytes and innate memory NK cells which are crucial for the antiviral immune response. Therefore, strategies to prevent COVID-19 in health workers (HW) should be carried out to prevent them becoming unwell so that they can continue to work during the pandemic. The hypothesis is that BCG will improve the innate immune response and prevent symptomatic infection or COVID-19 severity. The primary objective is to verify the effectiveness and safety of the BCG vaccine to prevent or reduce incidence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the city of Goiânia (Brazil) among HW previously vaccinated with BCG and also its severity and mortality during the pandemic of the disease. Secondary objectives are to estimate the incidence of COVID-19 among these professionals and the innate immune response elicited to BCG. TRIAL DESIGN: This a phase II trial for repositioning BCG as a preventive strategy against COVID-19. The trial is an open-label, parallel-group randomised clinical trial, comparing HW vaccinated with BCG and HW not vaccinated. PARTICIPANTS: The trial will recruit 800 HW of Goiânia - Goiás, Brazil to reach a total of 400 HW included after comorbidities questioning and laboratorial evaluation. Eligibility criteria: Any HW presenting BCG vaccination scar with direct contact with suspected COVID-19 patients for at least 8 hours per week, whether in hospital beds, ICU, or in transportation or admission (nurses, doctors, physiotherapists, nutritionists, receptionists, etc.) who have negative IgM and IgG COVID-19 test. Participants with any of the following characteristics will be excluded: - Have had in the last fifteen days any signs or symptoms of virus infection, including COVID-19; - Have had fever in the last fifteen days; - Have been vaccinated fifteen days before the inclusion; - Have a history or confirmation of any immunosuppressive disease such as HIV, presented solid tumour in the last two years or autoimmune diseases; - Are under preventive medication with antibiotics, steroid anti-inflammatories, or chemotherapy; - Have less than 500 neutrophils per mL of blood; - Have previously been diagnosed with tuberculosis; - Are breastfeeding or pregnant; - Are younger than 18 years old; - Are participating as an investigator in this clinical trial. INTERVENTION AND COMPARATOR: HW will be randomized into the BCG vaccinated group or the BCG unvaccinated control group. The BCG vaccinated group will receive in the right arm, intradermally, a one off dose of 0.1 mL corresponding to approximately 2 x105 to 8 x105 CFU of live, freeze-dried, attenuated BCG Moscow 361-I, Bacillus Calmette Guerin vaccine (Serum Institute of India PVT. LTD.). The unvaccinated control group will not be vaccinated. The HW allocated in both groups will be followed up at specific times points until 180 days post inclusion. The vaccinated and control groups will be compared according to COVID-19 related outcomes. MAIN OUTCOMES: The primary outcomes are the incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital during the 180 days of follow up. The secondary outcome is the innate immune response elicited 15-20 days after vaccination. RANDOMISATION: The vaccine vial contains approximately 10 doses. In order to optimize the vaccine use, the randomisation was performed in blocks of 20 participants using the platform randomization.com [ http://www.jerrydallal.com/random/permute.htm ]. The randomization was prepared before any HW inclusion. The results were printed and inserted in sealed envelopes that were numbered with BCG-001 to BCG-400. The printed results as well the envelopes had the same numbers. At the time of the randomisation, each participant that meets the inclusion criteria will receive a consecutive participant number [BCG-001-BCG-400]. The sealed envelope with the assigned number, blinded to the researchers, will be opened in front of the participant and the arm allocation will be known. BLINDING (MASKING): There is no masking for the participants or for the healthcare providers. The study will be blinded to the laboratory researchers and to those who will be evaluating the outcomes and performing the statistical analyses. In this case, only the participant identification number will be available. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Four hundred heath workers will be randomised in two groups. Two hundred participants will be vaccinated, and 200 participants will not be vaccinated. TRIAL STATUS: The protocol approved by the Brazilian Ethical Committee is the seventh version, number CAAE: 31783720.0.0000.5078. The trial has been recruiting since September 20th, 2020. The clinical trial protocol was registered on August 5th, 2020. It is estimated that recruitment will finish by March 2021. TRIAL REGISTRATION: The protocol number was registered on August 5th, 2020 at REBEC (Registro Brasileiro de Ensaios Clínicos). Register number: RBR-4kjqtg and WHO trial registration number UTN: U1111-1256-3892. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Asunto(s)
Vacuna BCG/administración & dosificación , Infecciones por Coronavirus/prevención & control , Inmunidad Innata/inmunología , Pandemias/prevención & control , Neumonía Viral/prevención & control , Betacoronavirus/inmunología , Brasil/epidemiología , Estudios de Casos y Controles , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/virología , Protección Cruzada/inmunología , Estudios de Seguimiento , Personal de Salud/estadística & datos numéricos , Hospitalización/estadística & datos numéricos , Humanos , Inmunización Secundaria/métodos , Inmunoglobulina G/sangre , Inmunoglobulina M/sangre , Incidencia , Inyecciones Intradérmicas , Células Asesinas Naturales/inmunología , Neumonía Viral/epidemiología , Neumonía Viral/inmunología , Neumonía Viral/virología , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/métodos , Seguridad , Resultado del Tratamiento
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA
...