BCG vaccine / Baylor College of Medicine - LARVOL DELTA

BCG-Induced DNA Methylation Changes Improve Coronavirus Disease 2019 Vaccine Immunity Without Decreasing the Risk for Severe Acute Respiratory Syndrome Coronavirus 2 Infection. (PubMed, Open Forum Infect Dis) - "The BCG vaccine induces trained immunity, an epigenetic-mediated increase in innate immune responsiveness...Secondary analysis demonstrated that 12 months following vaccination, BCG increased coronavirus vaccine immunity compared to those who did not receive BCG. This increase in COVID-19 vaccine immunity correlated with BCG-induced DNA methylation changes."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • IL1B • IL6 • TNFA

The Financial Burden of Localized and Metastatic Bladder Cancer. (PubMed, Eur Urol) - "BCa treatment, particularly in advanced stages, imposes a substantial economic burden. Innovations in care, while improving oncologic outcomes, necessitate detailed cost-effectiveness assessments. Addressing these economic challenges is essential for optimizing BCa management, targeting patients at a higher risk of FT, and improving patient quality of life."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Effectiveness of the primary Bacillus Calmette-Guérin vaccine against the risk of Mycobacterium tuberculosis infection and tuberculosis disease: a meta-analysis of individual participant data. (PubMed, Lancet Microbe) - "Protection from the BCG vaccination against M tuberculosis infection, measured as QuantiFERON conversion, is inconsistent across different groups. Among groups with recent household exposure, QuantiFERON conversion is consistent with protection against disease and could be evaluated as a proxy for disease in tuberculosis vaccine trials. We found that TST lacks value for prevention in phase 2b proof-of-concept trials."

Journal • Retrospective data • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • IFNG

BADAS: BCG Vaccine for Health Care Workers as Defense Against COVID 19 (clinicaltrials.gov) - P4 | N=659 | Completed | Sponsor: Texas A&M University | Active, not recruiting ➔ Completed | N=1800 ➔ 659

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer. (PubMed, Bladder Cancer) - "The workshop discussed several important opportunities for trial design refinement in NMIBC. FDA encourages sponsors to meet with the appropriate review division to discuss trial design proposals for NMIBC early in drug development."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

Interruptions in bladder cancer care during the COVID-19 public health emergency. (PubMed, Urol Oncol) - "Bladder cancer care was minimally restricted compared with more pronounced restrictions seen in general elective surgeries during the COVID-19 pandemic."

Journal • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Solid Tumor • Urology

Bacillus Calmette-Guérin vaccination as defense against SARS-CoV-2 (BADAS): a randomized controlled trial to protect healthcare workers in the USA by enhanced trained immune responses. (PubMed, Trials) - P4 | "It is expected this trial will allow evaluation of the effects of BCG vaccination at a population level in high-risk healthcare individuals through a mitigated clinical course of SARS-CoV-2 infection and inform policy making during the ongoing epidemic."

Journal • Cardiovascular • Diabetes • Genetic Disorders • Hypertension • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Obesity • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Tuberculosis

BADAS: BCG Vaccine for Health Care Workers as Defense Against COVID 19 (clinicaltrials.gov) - P4 | N=1800 | Active, not recruiting | Sponsor: Texas A&M University | Trial completion date: May 2022 ➔ May 2023 | Trial primary completion date: May 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Infant BCG vaccination and risk of pulmonary and extrapulmonary tuberculosis throughout the life course: a systematic review and individual participant data meta-analysis. (PubMed, Lancet Glob Health) - "Our results suggest that BCG vaccination at birth is effective at preventing tuberculosis in young children but is ineffective in adolescents and adults. Immunoprotection therefore needs to be boosted in older populations."

Journal • Retrospective data • Review • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • IFNG

Plasma Metagenomic Sequencing Expedites Diagnosis of Disseminated BCG in an Infant With IKBKB Mutation. (PubMed, Pediatr Infect Dis J) - "In an infant with a unique IEI, plasma mNGS provided the first diagnosis of disseminated BCG infection. We believe that early initiation of antimycobacterial treatment improved the infant's clinical outcome. Plasma mNGS testing should be considered as a noninvasive screen for infectious pathogens in children with IEIs before SCT."

Journal • Bone Marrow Transplantation • Immunology • Infectious Disease • Otorhinolaryngology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Transplantation • Tuberculosis • IKBKB

Utility of Blue Light Cystoscopy for Post-BCG Bladder Cancer Recurrence Detection: Implications for Clinical Trial Recruitment and Study Comparisons. (PubMed, J Urol) - "BLC helped detect recurrences after recent BCG that would have been missed with WLC alone. Providers should consider BLC for high-risk patients undergoing BCG, and should discuss the risk of false positives with these patients. As clinical trials of novel therapies for BCG unresponsive disease increase and there are no clear guidelines on BLC use for post-treatment cystoscopies, it is important to consider how variable BLC use could affect enrollment and comparisons of these studies."

Clinical • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

BADAS: BCG Vaccine for Health Care Workers as Defense Against COVID 19 (clinicaltrials.gov) - P4; N=1800; Active, not recruiting; Sponsor: Texas A&M University; Recruiting ➔ Active, not recruiting; Trial completion date: Nov 2021 ➔ May 2022; Trial primary completion date: May 2021 ➔ May 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A recombinant bovine adenoviral mucosal vaccine expressing mycobacterial antigen-85B generates robust protection against tuberculosis in mice. (PubMed, Cell Rep Med) - "BAdv protected mice against tuberculosis both as a booster after BCG vaccine (>1.4-log reduction in Mtb lung burden) and as a single intranasal dose (>0.5-log reduction). Protection was associated with robust CD4 and CD8 effector (T), central memory (T), and CD103/CD69 lung-resident memory (T) T cell expansion, revealing BAdv as a promising mucosal vaccine for tuberculosis."

Journal • Preclinical • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD69 • CD8 • ITGAE

Approaches to Non-Muscle-Invasive Bladder Cancer. (PubMed, Curr Oncol Rep) - "The present Bacillus Calmette-Guerin (BCG) shortage in the USA has led to new strategies to prioritize the most high-risk cases. The entity of BCG-unresponsive high-risk NMIBC remains a challenge to manage, with multiple novel treatments under investigation; fortunately, new therapies have been approved, such as immune checkpoint inhibitors, and others are showing tremendous promise. The standardization of NMIBC management, with evolving detection techniques and therapeutics, offers great potential to improve patient outcomes and survivorship."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • Urothelial Cancer

BCG Vaccine for Health Care Workers as Defense Against COVID 19 (clinicaltrials.gov) - P4; N=1800; Recruiting; Sponsor: Texas A&M University; Not yet recruiting ➔ Recruiting; N=700 ➔ 1800

Clinical • Enrollment change • Enrollment open