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1.
BMC Pediatr ; 21(1): 218, 2021 05 04.
Artículo en Inglés | MEDLINE | ID: mdl-33947371

RESUMEN

BACKGROUND: Niemann-Pick C disease is a rare autosomal recessive lysosomal lipid storage disorder. Some primary immunodeficiency diseases patients developed regional disease or disseminated disease after vaccinating BCG. It is unclear whether NPC gene deficiency is associated with Mycobacteria infection. CASE PRESENTATION: We report and discuss a case of a child who presented at the age of 6 months with NPC1 and BCG-itis. The patient was treated with Miglustat and the symptom of lymphadenopathy was improved. CONCLUSIONS: We reasonably speculate that NPC1 is a susceptibility gene of Mtb infection and mainly affects innate immunity. Once diagnosed, the infant should not be vaccinated with BCG and early treated.


Asunto(s)
Vacuna BCG , Enfermedad de Niemann-Pick Tipo C , Vacuna BCG/efectos adversos , Niño , Familia , Humanos , Lactante , Enfermedad de Niemann-Pick Tipo C/diagnóstico , Enfermedad de Niemann-Pick Tipo C/genética
2.
Vaccine ; 39(20): 2736-2745, 2021 05 12.
Artículo en Inglés | MEDLINE | ID: mdl-33810902

RESUMEN

INTRODUCTION: Revaccination with Bacillus Calmette-Guérin (BCG) vaccine is not generally recommended due to a lack of proven efficacy of repeat doses for protection against tuberculosis. However, there is a growing interest in the use of BCG vaccine for its 'off-target' effects which might involve revaccination. We did a systematic review of the safety of BCG revaccination. METHODS: MEDLINE (1946 to March 2020) and the BCG World Atlas (updated 2017) were searched, limiting to studies of BCG administration by the intradermal or percutaneous route. Adverse events as well as patient and vaccine characteristics were reviewed. RESULTS: The search identified 388 articles, of which 24 met the inclusion criteria. These reported 22 studies comprising eight randomised trials, four case-control studies, four observational studies and six case series or reports. Overall, there was evidence for a small increase in the rate of mild local and systemic reactions. No serious adverse events were reported in immunocompetent individuals. CONCLUSIONS: Evidence to date suggests that revaccination with BCG vaccine carries minimal risk. Future studies of BCG vaccine for novel applications should report adverse event data stratified by prior BCG vaccination status.


Asunto(s)
Mycobacterium bovis , Tuberculosis , Vacuna BCG/efectos adversos , Humanos , Inmunización Secundaria , Tuberculosis/prevención & control , Vacunación
3.
Epilepsy Behav ; 118: 107924, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33838621

RESUMEN

OBJECTIVE: Bacille de Calmette et Guérin (BCG) is a live vaccine for tuberculosis that is administered to all infants in Japan. Adrenocorticotropic hormone (ACTH) therapy for West syndrome (WS) causes immunosuppression and may result in BCG infection after BCG vaccination. We evaluated the safety of ACTH therapy initiated shortly after BCG vaccination. METHODS: We analyzed patients with WS who received ACTH therapy between 2005 and 2018. We evaluated the interval between BCG and ACTH therapy, and the rate of BCG infection during and after ACTH therapy, by retrospective chart review. RESULTS: Seventy-nine patients were included in the analysis. Twenty-three patients received ACTH therapy prior to BCG vaccination. For the remaining 56 patients, the median interval between BCG vaccination and the start of ACTH therapy (BCG-ACTH interval) was 91.5 (range 14-280) days. The BCG-ACTH interval was shorter in patients with unknown than in those with known etiologies. It was <8 weeks in 13 patients (10 with unknown and 3 with known etiologies). The minimum BCG-ACTH interval was 14 days. Six patients with epileptic spasms received BCG vaccinations because physicians did not recognize their seizures. None of the patients developed BCG infection. CONCLUSION: No patients who received ACTH therapy after BCG, even at an interval of 8 weeks, developed BCG infection. The timing of ACTH therapy initiation should be based on the risk of BCG-related adverse events and the adverse effects of any delay.


Asunto(s)
Hormona Adrenocorticotrópica/efectos adversos , Hormona Adrenocorticotrópica/uso terapéutico , Vacuna BCG , Espasmos Infantiles , Vacuna BCG/efectos adversos , Humanos , Lactante , Japón , Estudios Retrospectivos , Espasmos Infantiles/tratamiento farmacológico , Espasmos Infantiles/etiología , Vacunación/efectos adversos
5.
Curr Opin Urol ; 31(3): 178-187, 2021 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-33742981

RESUMEN

PURPOSE OF REVIEW: Although radical cystectomy represents the gold standard treatment for patients with high-risk nonmuscle invasive bladder cancer (NMIBC) whose disease does not respond to bacillus Calmette-Guérin (BCG), many patients are unable or unwilling to undergo surgery. The need remains for effective bladder-preserving therapies. This review aims to describe existing treatments, contemporary research in this field and ongoing trials of salvage therapies for patients with BCG-unresponsive NMIBC. RECENT FINDINGS: Intravesical chemotherapy has been utilized frequently in this setting. Emerging data on combination regimens such as intravesical gemcitabine and docetaxel and intravesical cabazitaxel, gemcitabine and cisplatin are promising; nevertheless, larger, prospective trials are needed. Meanwhile, the intravenous checkpoint inhibitor pembrolizumab was recently FDA-approved for patients BCG-unresponsive NMIBC. Encouraging clinical trial results for intravesical nadofaragene firadenovec, oportuzumab monatox and ALT-803 + BCG have been released, while data from trials of other treatment strategies, including novel chemotherapy and drug delivery, augmented BCG immunotherapy, adenoviral and gene therapy, targeted therapy, and combination systemic immunotherapy with intravesical agents, are eagerly awaited. SUMMARY: Several novel salvage therapies offer promise for patients with BCG-unresponsive NMIBC. Patient selection, efficacy, safety, cost and ease of administration must be carefully considered to determine the optimal treatment approach.


Asunto(s)
Vacuna BCG , Neoplasias de la Vejiga Urinaria , Administración Intravesical , Vacuna BCG/efectos adversos , Humanos , Invasividad Neoplásica , Recurrencia Local de Neoplasia , Estudios Prospectivos , Terapia Recuperativa , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico
6.
BMC Surg ; 21(1): 138, 2021 Mar 17.
Artículo en Inglés | MEDLINE | ID: mdl-33731071

RESUMEN

BACKGROUND: So called "mycotic" aortic aneurysms account for only 0.7 to 1.3% of all aortic aneurysms and are commonly caused by Staphylococcus aureus and Salmonella species. Bacillus Calmette-Guérin (BCG), a live attenuated strain of Mycobacterium bovis, is part of the therapy of non-muscle-invasive bladder cancer (NMIBC). CASE PRESENTATION: We report a case series of three patients with a mycobacterial graft infection related to BCG after surgical treatment of a presumed mycotic aortic aneurysm as an extremely rare complication after NMIBC treatment. All three patients developed aortic aneurysm after BCG instillation and subsequent mycobacterial graft infection. CONCLUSION: Diagnosis requires a high degree of suspicion because of its nonspecific symptoms and imaging. The pathogen is not detected by standard microbiological testing. Treatment includes triple antimycobacterial therapy and radical surgical interventions. Graft preservation may be considered if no anastomosis is involved.


Asunto(s)
Aneurisma Infectado/microbiología , Aneurisma de la Aorta/terapia , Vacuna BCG/efectos adversos , Inmunoterapia/efectos adversos , Infecciones por Mycobacterium/complicaciones , Mycobacterium bovis/aislamiento & purificación , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Administración Intravesical , Anciano , Antibacterianos/uso terapéutico , Vacuna BCG/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Infecciones por Mycobacterium/tratamiento farmacológico , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
7.
BMC Infect Dis ; 21(1): 151, 2021 Feb 05.
Artículo en Inglés | MEDLINE | ID: mdl-33546627

RESUMEN

BACKGROUND: Joint replacement is an effective intervention and prosthetic joint infection (PJI) is one of the most serious complications of such surgery. Diagnosis of PJI is often complex and requires multiple modalities of investigation. We describe a rare cause of PJI which highlights these challenges and the role of whole-genome sequencing to achieve a rapid microbiological diagnosis to facilitate prompt and appropriate management. CASE PRESENTATION: A 79-year-old man developed chronic hip pain associated with a soft-tissue mass, fluid collection and sinus adjacent to his eight-year-old hip prosthesis. His symptoms started after intravesical Bacillus Calmette-Guerin (BCG) therapy for bladder cancer. Synovasure™ and 16S polymerase chain reaction (PCR) tests were negative, but culture of the periarticular mass and genome sequencing diagnosed BCG infection. He underwent a two-stage joint revision and a prolonged duration of antibiotic therapy which was curative. CONCLUSIONS: BCG PJI after therapeutic exposure can have serious consequences, and awareness of this potential complication, identified from patient history, is essential. In addition, requesting appropriate testing is required, together with recognition that traditional diagnostics may be negative in non-pyogenic PJI. Advanced molecular techniques have a role to enhance the timely management of these infections.


Asunto(s)
Artritis Infecciosa/etiología , Vacuna BCG/efectos adversos , Infecciones Relacionadas con Prótesis/etiología , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Administración Intravesical , Anciano , Artritis Infecciosa/diagnóstico , Artritis Infecciosa/terapia , Vacuna BCG/administración & dosificación , Vacuna BCG/genética , Vacuna BCG/aislamiento & purificación , Genoma Bacteriano/genética , Prótesis de Cadera/efectos adversos , Prótesis de Cadera/microbiología , Humanos , Masculino , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/terapia , Resultado del Tratamiento
8.
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
9.
Aktuelle Urol ; 52(1): 43-46, 2021 Feb.
Artículo en Alemán | MEDLINE | ID: mdl-33525029

RESUMEN

Intravesical chemotherapy instillation is a unique method of treatment confined to urothelial neoplasia. Within the last decades, the substances Bacillus Calmette-Guerin (BCG) and mitomycin C (MMC) have evolved as the standard regimens for intravesical therapy. However, there are other chemotherapeutic substances, which are used less frequently, such as gemcitabine. In this article we aim to highlight the clinical relevance of intravesical gemcitabine instillations as treatment of non-muscle invasive bladder cancer.The histological subtypes of bladder tumours are as diverse as the intravesical regimens. Inverted papilloma is a rare entity in the spectrum of urological diseases. There seems to be an association with non-muscle invasive bladder cancer.We report a rare case of an inverted bladder papilloma treated with intravesical gemcitabine instillations after BCG failure and an allergic reaction to MMC.


Asunto(s)
Hipersensibilidad , Papiloma Invertido , Neoplasias de la Vejiga Urinaria , Administración Intravesical , Vacuna BCG/efectos adversos , Desoxicitidina/análogos & derivados , Humanos , Mitomicina/uso terapéutico , Vejiga Urinaria , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico
12.
Acta Paediatr ; 110(5): 1585-1590, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33314255

RESUMEN

AIM: Toll-like receptor 1 (TLR1), TLR2, TLR6 and TLR10 form the TLR2 subfamily. In our previous controlled studies in 132 subjects with osteitis after newborn Bacillus Calmette-Guérin (BCG) vaccination, TLR1, TLR2 and TLR6 variations were associated with the risk of BCG osteitis. Now, we evaluated the role of ten single nucleotide polymorphisms (SNP) of the TLR10 gene in this cohort. METHODS: Five synonymous TLR10 SNPs (rs10004195, rs10856837, rs10856838, rs1109695 and rs11466652), and five missense TLR10 SNPs (rs11096955, rs11096957, rs11466649, rs11466653 and rs11466658) were determined by polymerase chain reaction (PCR)-based sequencing in 132 former BCG osteitis patients. RESULTS: TLR10 rs10004195 polymorphism was associated with the risk of BCG osteitis, compared to Finnish population controls. The variant genotype (AT/AA) was present in 13.6% of cases versus 26.2% of controls (p = 0.024). Correspondingly, the minor allele frequency (MAF) was lower (0.075) in cases than in controls (0.152; p = 0.009). There were no significant differences in the genotypes of the other nine studied TLR10 SNPs or in the corresponding MAFs between cases and controls. CONCLUSION: Among ten studied TLR10 gene polymorphisms, the variation only in the TLR10 rs10004195 was associated with the BCG osteitis risk after newborn BCG vaccination.


Asunto(s)
Vacuna BCG , Osteítis/prevención & control , Receptor Toll-Like 10/genética , Vacuna BCG/efectos adversos , Finlandia , Humanos , Recién Nacido , Osteítis/inducido químicamente , Polimorfismo de Nucleótido Simple , Receptor Toll-Like 1/genética , Receptor Toll-Like 6/genética , Vacunación
13.
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
14.
Scand J Immunol ; 93(5): e13010, 2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-33325540

RESUMEN

World Health Organisation recommends the practice of BCG vaccination at birth in countries which have a high incidence of tuberculosis and/or high leprosy burden. The BCG vaccination is considered safe for a competent immune system. However, in children with weakened immune systems cause of which can be primary or secondary, the vaccine may lead to side effects which can be localized or disseminated. In this study, we report a spectrum of inborn errors of immunity (IEI) commonly referred to as primary immunodeficiency disorders (PIDs) diagnosed in a large cohort of patients presenting with complications to BCG vaccination from India. Retrospective data analysis of patients referred to ICMR- National Institute of Immunohematology (ICMR-NIIH) for IEI workup between 2007 and 2019 was done. IEI was identified in n = 52/90 (57.7%) patients presenting with BCG complications. Of these, n = 13(14.4%) patients were diagnosed with severe combined immune deficiency, n = 15(16.7%) with chronic granulomatous disease, n = 19(21.1%) with Inborn errors of IFN-γ immunity, n = 4(4.4%) with Combined immunodeficiency and n = 1(1.1%) with Leucocyte Adhesion Deficiency type1. Majority of cases with BCGosis (88%) had an underlying IEI. This study strongly highlights the need for evaluation of patients with BCG complications for underlying IEI. While disseminated BCGosis strongly predicts underlying IEI, even localized persistent adenitis may be a warning sign of underlying IEI. It is also strongly recommended to record a family history of previous sibling death prior to administration of this live vaccine and deferring live vaccine till the diagnosis of IEI is ruled out in cases with a positive family history.


Asunto(s)
Vacuna BCG/efectos adversos , Enfermedad Granulomatosa Crónica/patología , Inmunodeficiencia Combinada Grave/patología , Tuberculosis Pulmonar/prevención & control , Vacunación/efectos adversos , Vacuna BCG/inmunología , Femenino , Enfermedad Granulomatosa Crónica/diagnóstico , Enfermedad Granulomatosa Crónica/inmunología , Humanos , India , Lactante , Masculino , Mycobacterium tuberculosis/inmunología , Inmunodeficiencia Combinada Grave/diagnóstico , Inmunodeficiencia Combinada Grave/inmunología , Resultado del Tratamiento
15.
Rev Paul Pediatr ; 39: e2019338, 2021.
Artículo en Portugués, Inglés | MEDLINE | ID: mdl-32876305

RESUMEN

OBJECTIVE: To describe the case of an infant - diagnosed with incomplete Kawasaki disease - who developed BCG scar reactivation. CASE DESCRIPTION: A 6-month-old patient was admitted to hospital with fever associated with ocular hyperemia, cervical lymphadenopathy, and hyperemic lips, and remained hospitalized for 12 days. The physical examination revealed an inflammatory reaction at the site of the BCG scar, leading to the diagnosis of incomplete Kawasaki disease. The patient was treated with venous immunoglobulin, but presented recurrence of Kawasaki disease, with subsequent onset of coronary artery disease. COMMENTS: BCG scar reactivation is an important finding in countries where the vaccine is routinely given and may be a useful marker for early diagnosis of Kawasaki disease, especially in its incomplete form.


Asunto(s)
Vacuna BCG/inmunología , Síndrome Mucocutáneo Linfonodular/diagnóstico , Vacuna BCG/efectos adversos , Biomarcadores , Brasil , Cicatriz/inmunología , Cicatriz/patología , Humanos , Inmunoglobulinas Intravenosas/uso terapéutico , Lactante , Masculino , Síndrome Mucocutáneo Linfonodular/tratamiento farmacológico , Síndrome Mucocutáneo Linfonodular/inmunología
16.
Allergol. immunopatol ; 48(6): 729-737, nov.-dic. 2020. tab, graf
Artículo en Inglés | IBECS | ID: ibc-199264

RESUMEN

BACKGROUND: Bacille Calmette-Guerin (BCG) vaccination has a great impact on the prevention of severe complications of tuberculosis. However, in patients with primary immunodeficiencies (PID), it can lead to severe complications such as severe combined immunodeficiency, chronic granulomatous disease, and Mendelian susceptibility to mycobacterial disease. This study highlights the demographics, clinical complications and laboratory parameters among PID patients associated with BCG vaccination side effects. METHODS: One hundred and thirty-seven PID patients with BCGosis were evaluated in this study, based on the complications following BCG vaccination. RESULTS: The mean age of the patients with BCG complications at the time of the first visit was five years. The within-group comparison of patients showed a highly significant incidence of pneumonia and hepatomegaly in severe combined immunodeficiency patients. Furthermore, the immunologic data showed an increase in the overall rates of lymphocytes such as CD3+, CD4+ and CD8 + T cells in Mendelian susceptibility to mycobacterial disease patients. The level of immunoglobulins has also increased in chronic granulomatous disease patients. CONCLUSION: The high rate of undiagnosed PIDs predisposes individuals to a high risk of severe side effects as a result of BCG vaccination, as well as infants that are less than one month of age. Therefore, there is a need for early screening and diagnosis of PIDs before exposing unknown PID status patients to BCG vaccination. The benefits of screening and early diagnosis of PID cannot be overemphasized, especially in patients with a previous family history of immunodeficiency


No disponible


Asunto(s)
Humanos , Masculino , Femenino , Lactante , Preescolar , Niño , Adolescente , Vacuna BCG/efectos adversos , Síndromes de Inmunodeficiencia/inducido químicamente , Factores de Riesgo , Factores de Edad , Estadísticas no Paramétricas , Síndromes de Inmunodeficiencia/mortalidad , Factores de Tiempo , Diagnóstico Precoz , Irán/epidemiología
17.
Rev Med Suisse ; 16(710): 1920-1923, 2020 Oct 14.
Artículo en Francés | MEDLINE | ID: mdl-33058578

RESUMEN

Intravesical bacillus Calmette-Guérin immunotherapy is currently the most effective treatment for non-infiltrating bladder tumors. Although rare, « BCGitis ¼, local or disseminated, is a serious complication of this therapy. The diagnosis is difficult and often delayed but the infection may progress to multi-systemic failure and can be fatal. The microbiological samples are often negative, and biopsies sometimes do not help. Treatment consists of antimycobacterial agents in combination with corticosteroids in case of severe presentation.


Asunto(s)
Vacuna BCG/administración & dosificación , Vacuna BCG/efectos adversos , Inmunoterapia/efectos adversos , Inflamación/inducido químicamente , Administración Intravesical , Corticoesteroides/uso terapéutico , Antibacterianos/uso terapéutico , Humanos , Inflamación/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/terapia
18.
BMC Infect Dis ; 20(1): 708, 2020 Sep 29.
Artículo en Inglés | MEDLINE | ID: mdl-32993546

RESUMEN

BACKGROUND: Intravesical administration of Bacillus Calmette-Guérin (BCG) has proven useful for treatment and prevention of recurrence of superficial bladder cancer and in situ carcinoma. However, fatal side effects such as disseminated infections may occur. Early diagnosis and accurate therapy for interstitial pneumonitis (IP) are important because exacerbation of IP triggered by infections is the major cause of death. Although some fatality reports have suggested newly appeared IP after intravesical BCG treatment, to our knowledge, there are no reports which have demonstrated acute exacerbation of existing IP. Moreover, autopsy is lacking in previous reports. We report the case of a patient with fatal IP exacerbation after BCG instillation and the pathological findings of the autopsy. CASE PRESENTATION: A 77-year-old man with a medical history of IP was referred to our hospital because of fever and malaise. He had received an intravesical injection of BCG 1 day before the admission. His fever reduced after the use of antituberculosis drugs, so he was discharged home. He was referred to our hospital again because of a high fever 7 days after discharge. On hospitalisation, he showed high fever and systemic exanthema. Hepatosplenomegaly and myelosuppression were also observed. Biopsies revealed multiple epithelioid cell granulomas with Langhans giant cells of the liver and bone marrow. Biopsy DNA analyses of Mycobacterium bovis in the bone marrow, sputum, and blood were negative. His oxygen demand worsened drastically, and the ground-glass shadow expanded on the computed tomography scan. He was diagnosed with acute exacerbation of existing IP. We recommenced the antituberculosis drugs with steroid pulse therapy, but he died on day 35 because of respiratory failure. The autopsy revealed a diffuse appearance of multiple epithelioid cell granulomas with Langhans giant cells in multiple organs, although BCG was not evident. CONCLUSIONS: We report the first case of acute exacerbation of chronic IP by BCG infection. This is also the first case of autopsy of a patient with acute exacerbation of existing IP induced by intravesical BCG treatment. Whether the trigger of acute IP exacerbation is infection or hypersensitivity to BCG is still controversial, because pathological evidence confirming BCG infection is lacking. Physicians who administer BCG against bladder cancer should be vigilant for acute exacerbation of IP.


Asunto(s)
Antituberculosos/uso terapéutico , Vacuna BCG/efectos adversos , Enfermedades Pulmonares Intersticiales/tratamiento farmacológico , Enfermedades Pulmonares Intersticiales/etiología , Infecciones por Mycobacterium no Tuberculosas/tratamiento farmacológico , Infecciones por Mycobacterium no Tuberculosas/etiología , Esteroides/uso terapéutico , Brote de los Síntomas , Administración Intravesical , Anciano , Autopsia , Vacuna BCG/administración & dosificación , Vacuna BCG/uso terapéutico , Carcinoma in Situ/tratamiento farmacológico , Carcinoma in Situ/prevención & control , Resultado Fatal , Humanos , Enfermedades Pulmonares Intersticiales/microbiología , Masculino , Infecciones por Mycobacterium no Tuberculosas/diagnóstico , Mycobacterium bovis/genética , Resultados Negativos , Recurrencia Local de Neoplasia/tratamiento farmacológico , Recurrencia Local de Neoplasia/prevención & control , Quimioterapia por Pulso , Resultado del Tratamiento , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/prevención & control
19.
Cell ; 183(2): 315-323.e9, 2020 10 15.
Artículo en Inglés | MEDLINE | ID: mdl-32941801

RESUMEN

BCG vaccination in children protects against heterologous infections and improves survival independently of tuberculosis prevention. The phase III ACTIVATE trial assessed whether BCG has similar effects in the elderly. In this double-blind, randomized trial, elderly patients (n = 198) received BCG or placebo vaccine at hospital discharge and were followed for 12 months for new infections. At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo). The incidence of new infections was 42.3% (95% CIs 31.9%-53.4%) after placebo vaccination and 25.0% (95% CIs 16.4%-36.1%) after BCG vaccination; most of the protection was against respiratory tract infections of probable viral origin (hazard ratio 0.21, p = 0.013). No difference in the frequency of adverse effects was found. Data show that BCG vaccination is safe and can protect the elderly against infections. Larger studies are needed to assess protection against respiratory infections, including COVID-19 (ClinicalTrials.gov NCT03296423).


Asunto(s)
Vacuna BCG/efectos adversos , Vacuna BCG/inmunología , Infecciones del Sistema Respiratorio/prevención & control , Anciano , Anciano de 80 o más Años , Vacuna BCG/administración & dosificación , Método Doble Ciego , Femenino , Hospitalización , Humanos , Masculino , Persona de Mediana Edad , Infecciones del Sistema Respiratorio/inmunología , Virosis/inmunología , Virosis/prevención & control
20.
Trials ; 21(1): 799, 2020 Sep 17.
Artículo en Inglés | MEDLINE | ID: mdl-32943115

RESUMEN

OBJECTIVES: The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and mortality have been reported. We aim to test whether BCG vaccination may reduce susceptibility to and/or the severity of COVID-19 and other infectious diseases in health care workers (HCW) and thus prevent work absenteeism.The primary objective is to reduce absenteeism due to illness among HCW during the COVID-19 pandemic. The secondary objectives are to reduce the number of HCW that are infected with SARS-CoV-2, and to reduce the number of hospital admissions among HCW during the COVID-19 pandemic. HYPOTHESIS: BCG vaccination of HCW will reduce absenteeism by 20% over a period of 6 months. TRIAL DESIGN: Placebo-controlled, single-blinded, randomised controlled trial, recruiting study participants at several geographic locations. The BCG vaccine is used in this study on a different indication than the one it has been approved for by the Danish Medicines Agency, therefore this is classified as a phase III study. PARTICIPANTS: The trial will recruit 1,500 HCW at Danish hospitals.To be eligible for participation, a subject must meet the following criteria: Adult (≥18 years); Hospital personnel working at a participating hospital for more than 22 hours per week.A potential subject who meets any of the following criteria will be excluded from participation in this study: Known allergy to components of the BCG vaccine or serious adverse events to prior BCG administration Known prior active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species Previous confirmed COVID-19 Fever (>38 C) within the past 24 hours Suspicion of active viral or bacterial infection Pregnancy Breastfeeding Vaccination with other live attenuated vaccine within the last 4 weeks Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1) b) subjects with solid organ transplantation c) subjects with bone marrow transplantation d) subjects under chemotherapy e) subjects with primary immunodeficiency f) subjects under treatment with any anti-cytokine therapy within the last year g) subjects under treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months h) Active solid or non-solid malignancy or lymphoma within the prior two years Direct involvement in the design or the execution of the BCG-DENMARK-COVID trial Intervention and comparator: Participants will be randomised to BCG vaccine (BCG-Denmark, AJ Vaccines, Copenhagen, Denmark) or placebo (saline). An adult dose of 0.1 ml of resuspended BCG vaccine (intervention) or 0.1 ml of sterile 0.9% NaCl solution (control) is administered intradermally in the upper deltoid area of the right arm. All participants will receive one injection at inclusion, and no further treatment of study participants will take place. MAIN OUTCOMES: Main study endpoint: Days of unplanned absenteeism due to illness within 180 days of randomisation.Secondary study endpoints: The cumulative incidence of documented COVID-19 and the cumulative incidence of hospital admission for any reason within 180 days of randomisation.Randomisation: Randomisation will be done centrally using the REDCap tool with stratification by hospital, sex and age groups (+/- 45 years of age) in random blocks of 4 and 6. The allocation ratio is 1:1.Blinding (masking): Participants will be blinded to treatment. The participant will be asked to leave the room while the allocated treatment is prepared. Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference.The physicians administering the treatment are not blinded.Numbers to be randomised (sample size): Sample size: N=1,500. The 1,500 participants will be randomised 1:1 to BCG or placebo with 750 participants in each group.Trial Status: Current protocol version 5.1, from July 6, 2020.Recruitment of study participants started on May 18, 2020 and we anticipate having finished recruiting by the end of December 2020. TRIAL REGISTRATION: The trial was registered with EudraCT on April 16, 2020, EudraCT number: 2020-001888-90, and with ClinicalTrials.gov on May 1, 2020, registration number NCT04373291.Full protocol: The full protocol is attached as an additional file, accessible from the Trialswebsite (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 , Betacoronavirus/patogenicidad , Infecciones por Coronavirus/prevención & control , Personal de Salud , Salud Laboral , Pandemias/prevención & control , Neumonía Viral/prevención & control , Vacunación , Absentismo , Vacuna BCG/efectos adversos , Betacoronavirus/inmunología , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/transmisión , Infecciones por Coronavirus/virología , Dinamarca , Femenino , Humanos , Masculino , Estudios Multicéntricos como Asunto , Admisión del Paciente , Neumonía Viral/inmunología , Neumonía Viral/transmisión , Neumonía Viral/virología , Ensayos Clínicos Controlados Aleatorios como Asunto , Ausencia por Enfermedad , Método Simple Ciego , Factores de Tiempo , Resultado del Tratamiento
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