Infectious Diseases and Therapy最新文献

{"title":"Indirect Treatment Comparison of Long-Acting Injectable Cabotegravir as Pre-exposure Prophylaxis When Compared with no Pre-exposure Prophylaxis for HIV Prevention.","authors":"Neil Hawkins, Paul O'Brien, Juliette Thompson, Sarah-Jane Anderson, Eric Manalastas, Laure Dupont-Benjamin, Melanie Schroeder","doi":"10.1007/s40121-025-01172-9","DOIUrl":"10.1007/s40121-025-01172-9","url":null,"abstract":"<p><strong>Introduction: </strong>The efficacy of long-acting injectable cabotegravir (hereafter referred to as cabotegravir) versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) was demonstrated in two phase 3 randomized controlled trials (RCTs), HPTN 083 and HPTN 084. As these trials did not have a no-PrEP group, this analysis aimed to perform an indirect treatment comparison (ITC) of cabotegravir versus no PrEP via the common comparator of oral TDF/FTC.</p><p><strong>Methods: </strong>A systematic literature review identifying trials of oral or both oral and injectable PrEP reporting HIV acquisition and oral PrEP adherence, measured by detectable TDF/FTC plasma levels, was conducted (November 1, 2023). Heterogeneity in oral TDF/FTC adherence level between trials was expected to confound ITC estimates; therefore, a meta-regression of adherence and resulting oral PrEP effectiveness, or reduction in HIV acquisition, was incorporated into an ITC using a joint Bayesian model framework.</p><p><strong>Results: </strong>The analysis included ten RCTs. The meta-regression showed a strong relationship between oral TDF/FTC adherence and effectiveness. The predicted effectiveness of oral TDF/FTC versus no PrEP was greater for HPTN 083 (77%) compared with HPTN 084 (47%), reflecting the higher level of adherence observed in HTPN 083 (86%) compared with HPTN 084 (56%). Based on the ITC, the predicted effectiveness of cabotegravir versus no PrEP was similar for both populations investigated in HPTN 083 (92%) and HPTN 084 (93%).</p><p><strong>Conclusions: </strong>The ITC of cabotegravir versus no PrEP predicted similar estimates of cabotegravir effectiveness in the HPTN 083 and 084 trials, suggesting a very high level of efficacy despite differences in population, setting, underlying rate of HIV acquisition, and oral TDF/FTC adherence. These estimates support the generalizability of the cabotegravir results from both HPTN trials to other populations and regions than those in which these trials were conducted. Graphical abstract available for this article.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1739-1753"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered with Routine Pediatric Vaccines: A European Randomized Controlled Trial.","authors":"Federico Martinon-Torres, Miia M Virta, Susanna Koski, Ignacio Salamanca de la Cueva, Henryk T Szymanski, Samantha Bosis, Anca C Drăgănescu, Sven-Arne Silfverdal, Betzana Zambrano, Mandeep S Dhingra, Siham B'Chir, Olga Syrkina, Olga Lyabis, Gustavo A Vasquez, Christine Rehm","doi":"10.1007/s40121-025-01190-7","DOIUrl":"10.1007/s40121-025-01190-7","url":null,"abstract":"<p><strong>Introduction: </strong>The immunogenicity and safety of MenACYW-TT (MenQuadfi^®) were compared to another quadrivalent meningococcal conjugate vaccine, MCV4-TT (Nimenrix^®), when administered in infants alongside routine childhood vaccines in Europe.</p><p><strong>Methods: </strong>One set of healthy infants was randomized 1:1 to receive MenACYW-TT (group 1; n = 714) or MCV4-TT (group 2; n = 726) at age 2, 4, and 12-18 months (2 + 1 regimen) concomitantly with routine vaccines (including 10-valent pneumococcal conjugate vaccine). Another set was randomized 1:1 to receive MenACYW-TT in a 2 + 1 regimen (group 3; n = 112) or a 3 + 1 regimen at age 2, 4, 6, and 12-18 months (group 4; n = 108) concomitantly with routine vaccines (including 13-valent pneumococcal conjugate vaccine). Immune responses against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority of MenACYW-TT versus MCV4-TT was based on hSBA geometric mean titers (GMTs) 30 days post-booster (dose 3; primary endpoint) and rates of seroprotection 30 days post-dose 2 (secondary endpoint) against all vaccine meningococcal serogroups. Immune responses to co-administered vaccines and safety were also assessed. Post hoc, non-inferiority of MenACYW-TT was also assessed based on seroresponse rates 30 days post-booster.</p><p><strong>Results: </strong>Non-inferiority of MenACYW-TT versus MCV4-TT, based on GMTs post-booster, was demonstrated for serogroups C, W, and Y but not for A. GMTs against serogroups C, W, and Y were 1.5- to 4.5-fold higher with MenACYW-TT than MCV4-TT; those against serogroup A were marginally lower. Antibody responses in groups 3 and 4 against all serogroups were similar to group 1. Non-inferiority of MenACYW-TT based on seroresponse rates post-booster against all serogroups was demonstrated post hoc. No interference with concomitant routine vaccines nor safety concerns were identified.</p><p><strong>Conclusions: </strong>Consideration of all immunogenicity and safety data generated in this study supports the incorporation of MenACYW-TT into the routine childhood vaccination schedule as a 2 + 1 regimen starting at age 6 weeks.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov identifier: </strong>NCT03547271.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1843-1865"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339823/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of SARS-CoV-2 in Settings Including Point-of-Care: Performance of the Cobas SARS-CoV-2 NAT and Utility with the Cobas Liat System.","authors":"Myrto Bolanaki, Martin Möckel, Christopher Dodoo, Karen Gilliam, Elissa Robbins, D Jane Hata, Bruce White","doi":"10.1007/s40121-025-01186-3","DOIUrl":"10.1007/s40121-025-01186-3","url":null,"abstract":"<p><strong>Introduction: </strong>There is a need to confirm the diagnostic performance of point-of-care (POC) testing for severe acute respiratory coronavirus 2 (SARS-CoV-2) in emergency departments and time-sensitive outpatient settings. This study aimed to compare the diagnostic performance of the Cobas^® SARS-CoV-2 nucleic acid test for use on the Cobas Liat System (POC SARS-CoV-2) with the Cobas SARS-CoV-2 Qualitative Assay for use on the Cobas 6800/8800 System (68/8800) when used to detect SARS-CoV-2 infection from clinical specimens collected at POC settings.</p><p><strong>Methods: </strong>This prospective, two-site, non-interventional study, conducted in the US and Germany, collected fresh POC nasopharyngeal samples according to local procedures for upper respiratory swab sampling. Pairwise agreement was evaluated by estimating positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) between POC SARS-CoV-2 and 68/8800 assays. Site-specific analyses were also conducted.</p><p><strong>Results: </strong>Overall, 317 evaluable samples were collected from March 30 to July 2023 (US site) and from November 7, 2023 to April 4, 2024 (German site). Relative to 68/8800, POC SARS-CoV-2 had a PPA of 98.8% (169/171) and an NPA of 90.4% (132/146), while the OPA was 95.0%. Site-specific analyses were broadly comparable to the overall results, although enrichment for positive samples at the US site resulted in a PPA and NPA of 98.6% (139/141) and 55.6% (5/9), respectively.</p><p><strong>Conclusion: </strong>POC SARS-CoV-2 used in both POC and central laboratory settings showed good overall diagnostic performance relative to 68/8800, a widely used and accurate laboratory-based test, for detecting SARS-CoV-2. Efficient POC testing will help improve the timely management of SARS-CoV-2 infections.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1815-1827"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144626218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-Term Real-World Use of Cabotegravir/Rilpivirine: Adherence and Virological Efficacy over a 44-Month Observation Period.","authors":"Catharina Dannenberg, Hanna Matthews, Anja Hüfner, Gabriel V Drewinski, Anna Koval, Sabine Jordan, Stefan Schmiedel, Julian Schulze Zur Wiesch, Olaf Degen","doi":"10.1007/s40121-025-01178-3","DOIUrl":"10.1007/s40121-025-01178-3","url":null,"abstract":"<p><strong>Introduction: </strong>Long-acting cabotegravir/rilpivirine (LA-CAB/RPV) offers an effective alternative to daily oral antiretroviral therapy (ART) for people living with human immunodeficiency virus (PLWH), especially those with adherence challenges. Despite increasing use of LA-CAB/RPV, long-term real-world data on durability, adherence, and virological outcomes remain limited to 2 years. This study provides detailed longitudinal data at the individual PLWH level, assessing adherence, safety, and efficacy over a period of up to 10 years.</p><p><strong>Methods: </strong>All PLWH receiving LA-CAB/RPV at the University Medical Center Hamburg-Eppendorf between 2021 and 2025 were analyzed over 44 months, including injection-naïve individuals and former registration trial participants. Clinical, laboratory, immunological, and virological data were reviewed.</p><p><strong>Results: </strong>In total, 102 PLWH received ≥ 2 LA-CAB/RPV injections: (a) 77 injection-naïve and (b) 20 injection-experienced participants from clinical trials; and 5 off-label treated participants who were analyzed separately. Among participants treated in-label, 84% (1417/1690) of injections were administered on time. However, 82% of all participants (80/97) experienced ≥ 1 delay, with 96% (77/80) of delays limited to 8-14 days. Virological suppression (VL < 50 copies/mL) was achieved by 97% throughout the observation period (94/97). In total, 14% (14/97), all of cohort (a), discontinued injection therapy and switched back to oral ART. Injection site reactions were reported by 64%, while mild systemic side effects occurred in 41% at some point, most commonly neuropsychiatric symptoms in those with a history of depression. One confirmed virological failure (CVF) occurred after 40 months in cohort (a); two CVFs were observed in the small off-label-treated subgroup.</p><p><strong>Conclusions: </strong>This real-world study, with a 44-month observation period and follow-up of up to 10 years on LA-CAB/RPV, confirms its long-term efficacy and safety, supporting its durability as a maintenance option for PLWH, even with occasional delays and slightly lower adherence than seen in clinical trials, and additionally underscores the importance of individualized care and structured monitoring in real-world settings.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1775-1797"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144583826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Budget Impact Analysis of Fecal Microbiota Spores, Live-brpk (Formerly SER-109) for Recurrent Clostridioides difficile Infection in the United States.","authors":"Michele Wilson, Yoav Golan, Dianne Nguyen, Morteza Yazdani, Alpesh N Amin","doi":"10.1007/s40121-025-01169-4","DOIUrl":"10.1007/s40121-025-01169-4","url":null,"abstract":"<p><strong>Introduction: </strong>Fecal microbiota spores, live-brpk (hereafter VOS) is a microbiota-based orally administered therapeutic approved by the United States Food and Drug Administration for prevention of recurrent Clostridioides difficile infection (rCDI) following standard-of-care (SoC) antibiotics for the treatment of rCDI in patients aged ≥ 18 years. The study objective was to estimate the budget impact of introducing VOS within a hypothetical United States (US) health plan.</p><p><strong>Methods: </strong>A model was developed estimating the health plan budget impact of adding VOS to SoC compared with SoC alone for rCDI. Input data were from the published literature. Uptake of VOS was assumed at 10%, 20%, 30%, and 40% for recurrences 1 through 4, respectively. Annual and per-member per-month (PMPM) costs (2023 US dollars) were estimated from a health plan perspective. Scenario analyses considered different VOS uptake rates and use of fecal microbiota, live-jslm (hereafter RBL).</p><p><strong>Results: </strong>Including VOS on a formulary for rCDI was found to reduce overall annual costs in a 1-million-member commercial plan by US$42,328. VOS increased pharmacy costs (US$0.0820 PMPM), and these pharmacy costs were offset by other medical cost savings (-US$0.0856 PMPM) such that including VOS on a formulary was cost-saving at US$0.0035 PMPM. With these cost savings, introducing VOS prevented an estimated 27 recurrences among 225 individuals with rCDI. Scenario analyses indicated greater and/or earlier VOS uptake generates more cost savings owing to recurrence prevention, and that VOS was more cost-saving than RBL.</p><p><strong>Conclusions: </strong>Treatment with VOS is anticipated to reduce recurrences and health plan costs for those with rCDI. Using VOS earlier is expected to increase cost savings. Graphical abstract available for this article.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1799-1813"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339835/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144591184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Complementary Strategy of Maternal Immunization with RSVpreF Vaccine and Monoclonal Antibodies for the Prevention of Respiratory Syncytial Virus Among Italian Infants: A Cost-Effectiveness Assessment.","authors":"Barbara Polistena, Fabio Midulla, Giovanni Sotgiu, Daniela d'Angela, Roberto Di Virgilio, Federico Spandonaro","doi":"10.1007/s40121-025-01193-4","DOIUrl":"10.1007/s40121-025-01193-4","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Respiratory Syncytial Virus (RSV) is a leading cause of severe lower respiratory tract infections and is one of the primary causes of hospitalization in high income countries and death among children aged ≤ 1 year in lower income countries where the healthcare systems not always have the resources to provide appropriate intensive care to all infants with severe RSV infection. On the basis of the results of a large programme of clinical trials, the European Medicine Agency has recently approved a Bivalent Stabilized Prefusion F Subunit Vaccine (RSVpreFV) for maternal immunization, with a year-round administration between 24-36 weeks of gestation. The objective of the study is providing an estimation of the efficiency of complementary strategy RSVpreF and monoclonal antibodies for the prevention of RSV among Italian infants.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Using a model (with a cohort framework and a Markov-type process) specifically adapted to the Italian context, the study provided cost-effectiveness and cost-utility assessment of prevention strategies adding the maternal vaccination to the existing immunization opportunities with palivizumab or nirsevimab administered to high risk and unprotected infants.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The complementary strategy RSVpreFV plus palivizumab demonstrates significative health benefits versus palivizumab alone: it would reduce annual hospitalizations by 4097 cases (-25.8%), Emergency Department (ED) admissions not followed by hospitalization by 534 (-18.8%), with 25 years of life recovered, and an increase of 90 Quality Adjusted Life Years (QALYs). The strategy results cost-saving: the complementary strategy saves € 6.0 mil and € 8.4 mil per year in the NHS and in the Societal perspective, respectively; the complementary strategies of maternal vaccination plus nirsevimab also prove to have significant benefits versus the monoclonal antibody alone, providing a decrease equal to 941 annual hospitalizations (-9.0%), 6 years of life recovered, and an increase of 20 QALYs. The strategy saves € 2.6 mil and € 3.1 mil per year in the NHS and in the Societal perspective, respectively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;RSV is a leading cause of severe lower respiratory tract infections and is one of the primary causes of hospitalization in high income countries and death among children aged ≤ 1 year in lower income; bivalent Stabilized Prefusion F Subunit Vaccine (RSVpreFV) for maternal immunization proves to be effective in preventing RSV infections, avoiding severe disease. The modelling exercise shows that the complementary strategy of maternal vaccination with palivizumab or nirsevimab are both dominant (better health outcomes with lower costs) on monoclonal antibodies alone; the sensitivity analysis confirms that the complementary strategies in most of the simulation remain dominant or cost-effective adopting a low threshold for the willingness to pay; finally the compl","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1883-1897"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339814/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144659125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Characteristics and Prognosis of AIDS Complicated with Talaromycosis marneffei Infection: a Single-Center Retrospective Study.","authors":"Zhangyan Weng, Yijie Lin, Wenliang Dai, Yijuan Zheng, Huatang Zhang, Minghui Zheng, Haoyi He, Youzhi Hong, Dawu Zeng, Zhijun Su, Xueping Yu","doi":"10.1007/s40121-025-01198-z","DOIUrl":"10.1007/s40121-025-01198-z","url":null,"abstract":"<p><strong>Introduction: </strong>The objective of the study was to determine the clinical features and prognostic risk factors of acquired immunodeficiency syndrome (AIDS) combined with Talaromyces marneffei (TM) infection.</p><p><strong>Methods: </strong>We retrospectively analyzed the clinical data of 133 hospitalized patients diagnosed with AIDS and TM co-infection. Patients were divided into an improvement group and a deterioration group on the basis of their discharge outcomes. To further investigate the severity of adverse outcomes, subgroup analysis was performed on the deterioration group. Due to the issue of complete separation in the data, Firth's logistic regression model was employed to identify independent prognostic factors. Finally, the predictive performance of the model was evaluated using the receiver operating characteristic (ROC) curve.</p><p><strong>Results: </strong>Among 133 patients with AIDS and TM co-infection, the main manifestations were fever (93.23%) and severe immunodeficiency with median CD4⁺ T cell count of 8.50 cells/μL, with blood culture showing the highest positive rate (93.85%). Firth's logistic regression analysis revealed that timely antifungal therapy (OR 0.004, 95% CI <0.001-0.047, P < 0.001) and higher baseline albumin (ALB) levels (OR 0.858, 95% CI 0.732-0.973, P = 0.016) were independent protective factors for improving patient prognosis. The area under the receiver operating characteristic (ROC) curve (AUC) of the model was 0.930 (95% CI 0.878-0.982).</p><p><strong>Conclusions: </strong>Timely antifungal therapy and good nutritional status are key determinants of prognosis in patients with AIDS and TM co-infection. Early diagnosis, prompt initiation of effective treatment, and active nutritional support are of great significance for improving patient survival outcomes.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1935-1952"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339780/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Burden of Human Metapneumovirus (hMPV) Disease in Older and High-Risk Adults in Developed Countries: A Systematic Literature Review.","authors":"Ajoke Sobanjo-Ter Meulen, Aura V Gutierrez, Ornella Ruiz, Jennifer Eeuwijk, Hilde Vroling, Niranjan Kanesa-Thasan","doi":"10.1007/s40121-025-01187-2","DOIUrl":"10.1007/s40121-025-01187-2","url":null,"abstract":"<p><strong>Introduction: </strong>Human metapneumovirus (hMPV) causes respiratory infections in individuals of all age groups. While the evidence on hMPV epidemiology is growing, the hMPV burden in adults has not been synthesised. We conducted a critical review of published evidence on the burden of hMPV in older adults and adults with comorbidities.</p><p><strong>Methods: </strong>Articles reporting the burden of hMPV disease in adults ⩾50 years or ⩾18 years with comorbidities in developed countries were searched in Embase and MEDLINE (1/January/2000-12/June/2023) databases. Observational and interventional studies on community-based or medically attended populations were included. Outcomes of interest encompassed prevalence, incidence, clinical presentation, severe outcomes and complications, healthcare utilisation, coinfection with respiratory syncytial virus or influenza, and child-to-adult transmission. We assessed the risk of bias, performed a qualitative and quantitative synthesis, and calculated pooled estimates using random-effects meta-analysis (PROSPERO: CRD42023439068).</p><p><strong>Results: </strong>In total, 119 of 2847 articles met the inclusion criteria, covering 663,361 patients. hMPV accounted for 3.4% (95% confidence interval [CI] 2.7-4.2%, I² = 66%) of annual and 4.0% (95% CI 2.9-5.3%, I² = 78%) of seasonal symptomatic respiratory infections in older adults and 4.3% (95% CI 3.2-5.7%, I² = 66%, annual) and 5.1% (95% CI 3.2-7.9%, I² = 82%, seasonal) in high-risk adults. For high-risk adults, the estimated proportion of hMPV cases requiring hospitalisation was 51.4% (95% CI 33.2-69.3%, I² = 46%). Among medically attended cases, the proportions admitted to the intensive care unit and those resulting in mortality were 6.6% (95% CI 4.8-9.1%, I² = 34%) and 9.3% (95% CI 4.6-18%, I² = 0%), respectively.</p><p><strong>Conclusions: </strong>hMPV burden is substantial in the adult population, particularly among those with underlying diseases. Limited evidence exists in community settings, alongside the lack of routine testing for hMPV, which hinders the estimation of the actual burden of hMPV. These findings underscore the need for tailored prevention and treatment strategies for hMPV infection, such as vaccination or antiviral treatments.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1917-1933"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339782/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144753262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Immunogenicity of Monovalent Omicron KP.2-Adapted BNT162b2 COVID-19 Vaccine in Adults: Single-Arm Substudy from a Phase 2/3 Trial.","authors":"Oyeniyi Diya, Juleen Gayed, Francine S Lowry, Hua Ma, Vishva Bangad, Federico Mensa, Jing Zou, Xuping Xie, Yanping Hu, Mark Cutler, Todd Belanger, David Cooper, Xia Xu, Robin Mogg, Özlem Türeci, Uǧur Şahin, Kena A Swanson, Kayvon Modjarrad, Annaliesa S Anderson, Alejandra Gurtman, Nicholas Kitchin","doi":"10.1007/s40121-025-01185-4","DOIUrl":"10.1007/s40121-025-01185-4","url":null,"abstract":"<p><strong>Introduction: </strong>COVID-19 continues to cause substantial health burden, particularly among vulnerable populations. Vaccines remain a vital tool in preventing severe disease outcomes. As the causative pathogen, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve; therefore, updates may be needed to closely match COVID-19 vaccine composition to predominant circulating lineages to confer optimal protection.</p><p><strong>Methods: </strong>In this cohort from a substudy of an ongoing phase 2/3 trial, 102 healthy adults (18‒55 and > 55 years of age, n = 51 each) were vaccinated with Omicron KP.2-adapted BNT162b2. Serum neutralizing titers against Omicron KP.2, JN.1, and KP.3 were assessed before and through 1 month after vaccination. Immunogenicity in KP.2-adapted BNT162b2 recipients was compared with participants who received JN.1-adapted BNT162b2 in an earlier cohort of this substudy. Local reactions and systemic events through 7 days and adverse events (AEs) through 1 month are reported.</p><p><strong>Results: </strong>One month after vaccination, KP.2-adapted BNT162b2-elicited neutralizing titers against Omicron KP.2, JN.1, and KP.3 were numerically higher than those induced by JN.1-adapted BNT162b2. Geometric mean fold rises from before to 1 month after vaccination were numerically higher in those who received KP.2-adapted BNT162b2 compared with those who received JN.1-adapted BNT162b2 (9.4 vs. 6.8 for KP.2; 7.8 vs. 5.7 for JN.1; 9.2 vs. 7.0 for KP.3). Percentages of participants with seroresponses were numerically higher against KP.2 after KP.2-adapted BNT162b2 than JN.1-adapted BNT162b2 (75% vs. 65%) and similar against JN.1 and KP.3 for both vaccines (69% vs. 67% for JN.1; 74% vs. 73% for KP.3). Local reactions and systemic events were all mild to moderate in severity, AEs were infrequent, and no serious AEs or AEs leading to withdrawal were reported.</p><p><strong>Conclusions: </strong>Collectively, these immunogenicity, safety, and tolerability data support administration of KP.2-adapted BNT162b2 to protect against contemporaneous circulating lineages.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov identifier: </strong>NCT05997290.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1973-1987"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339817/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Effectiveness Analysis of a Bivalent RSVPreF Vaccine in Japanese Adults Aged 60 Years and Older.","authors":"Kosaku Komiya, Yoko Hirano, Kazumasa Kamei, Asuka Yoshida, Junko Morii, Ryohei Kobayashi, Reiko Sato","doi":"10.1007/s40121-025-01177-4","DOIUrl":"10.1007/s40121-025-01177-4","url":null,"abstract":"<p><strong>Introduction: </strong>Respiratory syncytial virus (RSV) is a major cause of acute respiratory illness. A bivalent RSV prefusion F protein-based (RSVpreF) vaccine was approved in Japan to prevent RSV-related diseases in older adults in 2024. This study evaluated the cost-effectiveness of the RSVpreF vaccine compared with no vaccination in Japanese adults aged 60 years and older from the payer and societal perspectives.</p><p><strong>Methods: </strong>A population-based, multi-cohort, Markov-type model was used to estimate the economic and health impact of vaccination against RSV over a lifetime horizon. Model inputs were derived from published Japanese and international sources. Vaccine effectiveness was derived from clinical trial data and assumed to wane over time. The base-case analysis was conducted assuming a vaccination rate of 50%. Scenario analyses, along with deterministic and probabilistic sensitivity analyses, were conducted to assess the uncertainty around model inputs.</p><p><strong>Results: </strong>The RSVpreF vaccine was anticipated to reduce 204,145 cases of RSV hospitalization, 113,170 cases of RSV emergency department visits, 542,790 cases of RSV outpatient visits, and 27,764 RSV-related deaths versus no vaccination. These reductions in disease burden resulted in savings of Japanese yen (JPY) 176,121 million in medical expenses and JPY 161,307 million in productivity losses. There was an incremental gain of 290,312 quality-adjusted life-years (QALYs), with incremental cost-effectiveness ratios (ICERs) of JPY 1,458,898/QALY from the payer perspective and JPY 903,263/QALY from the societal perspective, which was below the cost-effectiveness threshold of JPY 5 million/QALY. The scenario and sensitivity analyses confirmed the robustness of the results.</p><p><strong>Conclusions: </strong>The RSVpreF vaccine is cost-effective compared to no vaccination for adults aged 60 years and older in Japan. It has the potential to provide significant public health benefits by reducing the burden of RSV-related diseases.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":" ","pages":"1755-1773"},"PeriodicalIF":5.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339801/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}