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Background The adjuvanted RSV prefusion F protein–based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD) in ≥60-years-olds over 1 RSV season. We evaluated efficacy and safety of 1 RSVPreF3 OA dose and of 2 RSVPreF3 OA doses given 1 year apart against RSV-LRTD over 2 RSV seasons post–dose 1. Methods In this phase 3, blinded trial, ≥60-year-olds were randomized (1:1) to receive RSVPreF3 OA or placebo pre–season 1. RSVPreF3 OA recipients were re-randomized (1:1) to receive a second RSVPreF3 OA dose (RSV_revaccination group) or placebo (RSV_1dose group) pre–season 2; participants who received placebo pre–season 1 received placebo pre–season 2 (placebo group). Efficacy of both vaccine regimens against RSV-LRTD was evaluated over 2 seasons combined (confirmatory secondary objective, success criterion: lower limits of 2-sided CIs around efficacy estimates >20%). Results The efficacy analysis comprised 24 967 participants (RSV_1dose: 6227; RSV_revaccination: 6242; placebo: 12 498). Median efficacy follow-up was 17.8 months. Efficacy over 2 seasons of 1 RSVPreF3 OA dose was 67.2% (97.5% CI: 48.2–80.0%) against RSV-LRTD and 78.8% (95% CI: 52.6–92.0%) against severe RSV-LRTD. Efficacy over 2 seasons of a first dose followed by revaccination was 67.1% (97.5% CI: 48.1–80.0%) against RSV-LRTD and 78.8% (95% CI: 52.5–92.0%) against severe RSV-LRTD. Reactogenicity/safety of the revaccination dose were similar to dose 1. Conclusions One RSVPreF3 OA dose was efficacious against RSV-LRTD over 2 RSV seasons in ≥60-year-olds. Revaccination 1 year post–dose 1 was well tolerated but did not seem to provide additional efficacy benefit in the overall study population. Clinical Trials Registration ClinicalTrials.gov: NCT04886596. [ABSTRACT FROM AUTHOR]

Background Respiratory syncytial virus (RSV) disease in older adults is undercharacterized. To help inform future immunization policies, this study aimed to describe the disease burden in Canadian adults aged ≥50 years hospitalized with RSV. Methods Using administrative data and nasopharyngeal swabs collected from active surveillance among adults aged ≥50 years hospitalized with an acute respiratory illness (ARI) during the 2012–2013, 2013–2014, and 2014–2015 influenza seasons, RSV was identified using a respiratory virus multiplex polymerase chain reaction test to describe the associated disease burden, incidence, and healthcare costs. Results Of 7797 patients tested, 371 (4.8%) were RSV positive (2.2% RSV-A and 2.6% RSV-B). RSV prevalence varied by season from 4.2% to 6.2%. Respiratory virus coinfection was observed in 11.6% (43/371) of RSV cases, with influenza A being the most common. RSV hospitalization rates varied between seasons and increased with age, from 8–12 per 100 000 population in adults aged 50–59 years to 174–487 per 100 000 in adults aged ≥80 years. The median age of RSV cases was 74.9 years, 63.7% were female, and 98.1% of cases had ≥1 comorbidity. Among RSV cases, the mean length of hospital stay was 10.6 days, 13.7% were admitted to the intensive care unit, 6.4% required mechanical ventilation, and 6.1% died. The mean cost per RSV case was $13 602 (Canadian dollars) but varied by age and Canadian province. Conclusions This study adds to the growing literature on adult RSV burden by showing considerable morbidity, mortality, and healthcare costs in hospitalized adults aged ≥50 years with ARIs such as influenza. [ABSTRACT FROM AUTHOR]

Background: Respiratory syncytial virus (RSV) causes a substantial burden in older adults. Viral load in RSV-infected adults is generally lower compared to young children, which could result in suboptimal sensitivity of RSV diagnostics. Although the Xpert® Xpress Flu/RSV assay has been used in routine clinical care, its sensitivity to diagnose RSV infection in older adults is largely unknown. We aimed to compare the performance of the Xpert® Xpress Flu/RSV assay with real-time reverse-transcription polymerase chain reaction (RT-PCR) in home-dwelling older adults (≥60 years of age).Methods: Nasopharyngeal swabs were tested with Xpert® Xpress Flu/RSV and compared to RSV RT-PCR in older adults with acute respiratory tract infections with different levels of disease severity.Results: We studied 758 respiratory samples from 561 older adults from 2 consecutive RSV seasons. Thirty-five (4.6%) samples tested positive for RSV by at least 1 of the assays, of which 2 samples were negative by Xpert® Xpress Flu/RSV and 3 samples by real-time RT-PCR. The positive percentage agreement (PPA) was 90.9% (95% confidence interval [CI], 76.4%-96.8%) and negative percentage agreement was 99.7% (95% CI, 99.0%-99.9%). Viral loads were low (≤103 copies/mL or cycle threshold value ≥34) in all cases with discordant results for the 2 assays.Conclusions: The PPA of Xpert® Xpress Flu/RSV compared to routine RT-PCR is high for RSV detection in home-dwelling older adults. The assay is fast and easy to use at the point of care.Clinical Trials Registration: NCT03621930. [ABSTRACT FROM AUTHOR]

Background: Respiratory syncytial virus (RSV) infection in older adults is recognised as an important health issue. We aimed to assess the community burden of RSV in Europe in older adults aged ≥60 years., Methods: This international, prospective, observational cohort study is part of work by the REspiratory Syncytial virus Consortium in EUrope (RESCEU). Participants were recruited through general practitioners' (GPs) offices before two independent RSV seasons. Participants reported weekly about symptoms of acute respiratory tract infection (ARTI) during one RSV season. ARTI patients were tested for RSV during home visits and completed a daily symptom diary. RSV illness included PCR-confirmed ARTI and those showing seroconversion over the season. RSV ARTI was based on PCR alone (ClinicalTrials.gov, NCT03621930)., Results: We recruited 1040 participants (527 in season 2017-2018 and 513 in season 2018-2019) with a median age of 75 years (range 60-100 years). Of these, 1023 (99%) lived independently at home at baseline. RSV illness incidence was 22 out of 527 (4.2%) and 37 out of 513 (7.2%) in the respective seasons. RSV illness did not affect frailty or cardiopulmonary status during the course of the study. No patients were hospitalised or died from RSV illness. In the 36 patients with PCR confirmed RSV ARTI, symptom duration averaged 19 days, while a doctor's visit took place in 11 out of 36 cases (31%). RSV ARTI could not be differentiated clinically from all other ARTIs based on symptoms., Conclusion: This European study showed that RSV is prevalent in community-dwelling older adults and rarely causes severe disease. This suggests that watchful waiting, using a continuity of care approach to identify those who do need more intensive care, is often justified when RSV is suspected in family practice., Competing Interests: Conflict of interest: K. Korsten has nothing to disclose. Conflict of interest: N. Adriaenssens has nothing to disclose. Conflict of interest: S. Coenen reports grants and non-financial support from European Union (EU) Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA) Innovative Medicines Initiative 2 (IMI-2) Joint Undertaking (grant: 116019), during the conduct of the study. Conflict of interest: C. Butler reports grants from the National Institute for Health Research (NIHR) (as NIHR Senior Investigator), grants from the EU Horizon 2020 programme to support the study, grants from the NIHR Health Protection Research Unit on Health Care Associated Infections and Antimicrobial Resistance, grants from the NIHR Health for the MedTech and In Vitro Diagnostics Cooperative for innovative diagnostics and monitoring technology to enhance community healthcare, during the conduct of the study; personal fees for advisory board work from Pfizer and Roche Molecular Systems; and grants from Roche Molecular Diagnostics. Conflict of interest: B. Ravanfar has nothing to disclose. Conflict of interest: H. Rutter has nothing to disclose. Conflict of interest: J. Allen has nothing to disclose. Conflict of interest: A. Falsey reports grants from Janssen, Merck, Sharpe and Dohme, and Pfizer, as well as non-financial support for meeting attendance from Sanofi Pasteur, outside the submitted work. Conflict of interest: J-Y. Pirçon is an employee of GlaxoSmithKline Vaccines. Conflict of interest: O. Gruselle is an employee of GlaxoSmithKline. Conflict of interest: V. Pavot is an employee of Sanofi Pasteur. Conflict of interest: C. Vernhes is an employee of Sanofi Pasteur. Conflict of interest: S. Balla-Jhagjhoorsingh is an employee of Janssen Vaccines & Prevention. Conflict of interest: D. Öner is an employee of Janssen Pharmaceutica NV and reports grants from the IMI-2 Joint Undertaking (grant: 116019), during the conduct of the study. Conflict of interest: G. Ispas is an employee of Janssen Pharmaceutica NV. Conflict of interest: J. Aerssens is an employee of Janssen Pharmaceutica NV. Conflict of interest: V. Shinde has nothing to disclose. Conflict of interest: T. Verheij reports grants from Janssen Pharmaceuticals, Becton Dickinson, Abbott and Biomerieux, outside the submitted work. Conflict of interest: L. Bont has regular interaction with pharmaceutical and other industrial partners. He has not received personal fees or other personal benefits; however, University Medical Center Utrecht has received major funding for investigator-initiated studies from AbbVie, MedImmune, Janssen, the Bill and Melinda Gates Foundation, Nutricia (Danone) and MeMed Diagnostics; has received major cash or in kind funding as part of the public–private partnership, IMI-2 funded REspiratory Syncytial virus Consortium in EUrope (RESCEU) project from GlaxoSmithKline, Novavax, Janssen, AstraZeneca, Pfizer and Sanofi; has received major funding from Julius Clinical for participating in the INFORM study sponsored by MedImmune; has received minor funding for participation in trials by Regeneron and Janssen from 2015–2017; and has received minor funding for consultation and invited lectures by AbbVie, MedImmune, Ablynx, Bavaria Nordic, MabXience, Novavax, Pfizer and Janssen. L. Bont is also the founding chairman of the ReSViNET Foundation. Conflict of interest: J. Wildenbeest has nothing to disclose., (Copyright © ERS 2021.)

Introduction: Antigen-specific active immunotherapy is an investigational therapeutic approach of potential interest for bladder cancer regardless of disease stage. Clinical development of antigen-specific immunotherapeutics against bladder cancer must be preceded by assessment of the expression of relevant genes in bladder tumors. The objectives of this study (NCT01706185) were to assess the rate of expression of the MAGE-A3 and PRAME genes in bladder tumors and to investigate the feasibility of using formalin-fixed paraffin-embedded (FFPE) tumor tissues for testing., Materials and Methods: Archived FFPE bladder tumor specimens (any stage) were tested for mRNA expression of MAGE-A3 and PRAME using antigen-specific quantitative reverse transcription polymerase chain reaction assays. Data on patients and tumor characteristics were obtained from hospital records to investigate these characteristics' possible association with the antigen expression., Results: Over 92% of the 156 tumors examined gave valid antigen test results. Of the tumors with a valid test, 46.5% were MAGE-A3-positive, 32.2% were PRAME-positive and 59.7% positive for at least one of them. Exploratory analyses of possible associations between antigen expression and patient or tumor characteristics did not identify clear associations between antigen expression and any of the variables investigated., Conclusions: Assessment of tumor antigen mRNA expression by using FFPE bladder tissues was feasible. The rates of MAGE-A3-positive and PRAME-positive tumors indicate that both antigens may be interesting targets for immunotherapeutics against bladder cancer.