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Controlled human infection studies accelerate vaccine development.
J Infect Dis
January 2025
Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland 21218, USA.
Clinical trials that employ human challenge, also known as controlled human infection models (CHIM), have rapidly advanced vaccine development for multiple pathogens, including at least 30 disease models to date. CHIM studies, championed by networks of researchers, regulators, ethicists, technical experts, and other stakeholders, limit exposure of individuals to an investigational product, de-risk product investments, identify correlates of protection, and most importantly provide a prompt readout of vaccine efficacy. While CHIM studies provide multiple advantages, important challenges exist, including strengthening the relevance and comparability of CHIM study results to efficacy trials in endemic areas, particularly in resource-limited settings.
View Article and Find Full Text PDFImpact of Online Interactive Decision Tools on Women's Decision-Making Regarding Breast Cancer Screening: Systematic Review and Meta-Analysis.
J Med Internet Res
January 2025
Cancer Screening, American Cancer Society, Atlanta, GA, United States.
Background: The online nature of decision aids (DAs) and related e-tools supporting women's decision-making regarding breast cancer screening (BCS) through mammography may facilitate broader access, making them a valuable addition to BCS programs.
Objective: This systematic review and meta-analysis aims to evaluate the scientific evidence on the impacts of these e-tools and to provide a comprehensive assessment of the factors associated with their increased utility and efficacy.
Methods: We followed the 2020 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and conducted a search of MEDLINE, PsycINFO, Embase, CINAHL, and Web of Science databases from August 2010 to April 2023.
Oral Regimens for Rifampin-Resistant, Fluoroquinolone-Susceptible Tuberculosis.
N Engl J Med
January 2025
From Médecins Sans Frontières (L.G., F.V.), Sorbonne Université, INSERM Unité 1135, Centre d'Immunologie et des Maladies Infectieuses (L.G.), Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Universitaire Sorbonne Université, Hôpital Pitié-Salpêtrière, Centre National de Référence des Mycobactéries et de la Résistance des Mycobactéries aux Antituberculeux (L.G.), and Epicentre (M.G., E. Baudin), Paris, and Translational Research on HIV and Endemic and Emerging Infectious Diseases, Montpellier Université de Montpellier, Montpellier, Institut de Recherche pour le Développement, Montpellier, INSERM, Montpellier (M.B.) - all in France; Interactive Development and Research, Singapore (U.K.); McGill University, Epidemiology, Biostatistics, and Occupational Health, Montreal (U.K.); UCSF Center for Tuberculosis (G.E.V., P.N., P.P.J.P.) and the Division of HIV, Infectious Diseases, and Global Medicine (G.E.V.), University of California at San Francisco, San Francisco; the National Scientific Center of Phthisiopulmonology (A.A., E. Berikova) and the Center of Phthisiopulmonology of Almaty Health Department (A.K.), Almaty, and the City Center of Phthisiopulmonology, Astana (Z.D.) - all in Kazakhstan; Médecins Sans Frontières (C.B., I.M.), the Medical Research Council Clinical Trials Unit at University College London (I.M.), and St. George's University of London Institute for Infection and Immunity (S.W.) - all in London; MedStar Health Research Institute, Washington, DC (M.C.); Médecins Sans Frontières, Mumbai (V. Chavan), the Indian Council of Medical Research Headquarters-New Delhi, New Delhi (S. Panda), and the Indian Council of Medical Research-National AIDS Research Institute, Pune (S. Patil) - all in India; the Centre for Infectious Disease Epidemiology and Research (V. Cox) and the Department of Medicine (H. McIlleron), University of Cape Town, and the Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine (S.W.) - both in Cape Town, South Africa; the Institute of Tropical Medicine, Antwerp, Belgium (B. C. J.); Médecins Sans Frontières, Geneva (G.F., N.L.); Médecins Sans Frontières, Yerevan, Armenia (O.K.); the National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia (N.K.); Partners In Health (M.K.) and Jhpiego Lesotho (L.O.) - both in Maseru; Socios En Salud Sucursal Peru (L.L., S.M.-T., J.R., E.S.-G., D.E.V.-V.), Hospital Nacional Sergio E. Bernales, Centro de Investigacion en Enfermedades Neumologicas (E.S.-G.), Hospital Nacional Dos de Mayo (E.T.), Universidad Nacional Mayor de San Marcos (E.T.), and Hospital Nacional Hipólito Unanue (D.E.V.-V.) - all in Lima; Global Health and Social Medicine, Harvard Medical School (L.L., K.J.S., M.L.R., C.D.M.), Partners In Health (L.L., K.J.S., M.L.R., C.D.M.), the Division of Global Health Equity, Brigham and Women's Hospital (K.J.S., M.L.R., C.D.M.), the Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, (L.T.), and Harvard T.H. Chan School of Public Health (L.T.) - all in Boston; and the Indus Hospital and Health Network, Karachi, Pakistan (H. Mushtaque, N.S.).
Background: For decades, poor treatment options and low-quality evidence plagued care for patients with rifampin-resistant tuberculosis. The advent of new drugs to treat tuberculosis and enhanced funding now permit randomized, controlled trials of shortened-duration, all-oral treatments for rifampin-resistant tuberculosis.
Methods: We conducted a phase 3, multinational, open-label, randomized, controlled noninferiority trial to compare standard therapy for treatment of fluoroquinolone-susceptible, rifampin-resistant tuberculosis with five 9-month oral regimens that included various combinations of bedaquiline (B), delamanid (D), linezolid (L), levofloxacin (Lfx) or moxifloxacin (M), clofazimine (C), and pyrazinamide (Z).
First-Line Mobocertinib Versus Platinum-Based Chemotherapy in Patients With Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer in the Phase III EXCLAIM-2 Trial.
J Clin Oncol
January 2025
Department of Clinical Oncology, State Key Laboratory of Translational Oncology, Chinese University of China, Shatin, Hong Kong Special Administrative Region, China.
Purpose: Mobocertinib is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that targets exon 20 insertion (ex20ins) mutations in non-small cell lung cancer (NSCLC). This open-label, phase III trial (EXCLAIM-2: ClinicalTrials.gov identifier: NCT04129502) compared mobocertinib versus platinum-based chemotherapy as first-line treatment of ex20ins+ advanced/metastatic NSCLC.
View Article and Find Full Text PDFThe Southern Brazilian Registry of Atrial Fibrillation (SBR-AF Registry): Predictors of Atrial Arrhythmia Recurrence after First-Time Catheter Ablation.
Arq Bras Cardiol
January 2025
Serviço de Arritmia Cardíaca, Hospital SOS Cardio, Florianópolis, SC - Brasil.
Background: Treatment of atrial fibrillation (AF) with catheter ablation (CA) has evolved significantly. However, real-world data on long-term outcomes are limited, particularly in low- and middle-income countries.
Objective: This multicenter prospective cohort of consecutive patients aimed to evaluate the safety and efficacy of first-time CA for AF in Southern Brazil from 2009 to 2024.
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