Charissa Borja-Tabora, LakKumar Fernando, Eduardo Lopez Medina, Humberto Reynales, Luis Rivera, Xavier Saez-Llorens, Chukiat Sirivichayakul, Delia Yu, Nicolas Folschweiller, Kelley J Moss, Martina Rauscher, Vianney Tricou, Yuan Zhao, Shibadas Biswal
{"title":"Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group.","authors":"Charissa Borja-Tabora, LakKumar Fernando, Eduardo Lopez Medina, Humberto Reynales, Luis Rivera, Xavier Saez-Llorens, Chukiat Sirivichayakul, Delia Yu, Nicolas Folschweiller, Kelley J Moss, Martina Rauscher, Vianney Tricou, Yuan Zhao, Shibadas Biswal","doi":"10.1093/cid/ciae369","DOIUrl":"10.1093/cid/ciae369","url":null,"abstract":"<p><strong>Background: </strong>Dengue is an increasing threat to global health. This exploratory analysis evaluated the immunogenicity, safety, and vaccine efficacy (VE) of a live-attenuated tetravalent dengue vaccine (TAK-003) in participants enrolled in the phase 3 DEN-301 trial (NCT02747927), stratified by baseline age (4-5 years, 6-11 years, or 12-16 years).</p><p><strong>Methods: </strong>Participants were randomized 2:1 to receive 2 doses of TAK-003, administered 3 months apart, or placebo. Dengue serostatus was evaluated at enrolment. VE against virologically confirmed dengue (VCD) and hospitalized VCD; immunogenicity (geometric mean titers [GMTs]); and safety were evaluated per age group through ∼4 years postvaccination.</p><p><strong>Results: </strong>VE against VCD across serotypes was 43.5% (95% confidence interval [CI]: 25.3%, 57.3%) for 4-5 year-olds; 63.5% (95% CI: 56.9%, 69.1%) for 6-11 year-olds, and 67.7% (95% CI: 57.8%, 75.2%) for 12-16 year-olds. VE against hospitalized VCD was 63.8% (95% CI: 21.1%, 83.4%), 85.1% (95% CI: 77.1%, 90.3%), and 89.7% (95% CI: 77.9%, 95.2%), for the 3 age groups, respectively. GMTs remained elevated against all 4 serotypes for ∼4 years postvaccination, with no evident differences across age groups. No clear differences in safety by age were identified.</p><p><strong>Conclusions: </strong>This exploratory analysis shows TAK-003 was efficacious in dengue prevention across age groups in children and adolescents 4-16 years of age living in dengue endemic areas. Relatively lower VE in 4-5 year-olds was potentially confounded by causative serotype distribution, small sample size, and VE by serotype, and should be considered in benefit-risk evaluations in this age group.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"199-206"},"PeriodicalIF":8.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141598818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marva Seifert, Donald G Catanzaro, Michael Gracia, Naomi Hillery, Sabira Tahseen, Faisal Masood, Alamdar Hussain, Uzma Majeed, Rebecca E Colman, Rehan R Syed, Antonino Catanzaro, Timothy Rodwell
{"title":"Prospective Exploratory Evaluation of Cepheid Xpert Mycobacterium tuberculosis Host Response Cartridge: A Focus on Adolescents and Young Adults.","authors":"Marva Seifert, Donald G Catanzaro, Michael Gracia, Naomi Hillery, Sabira Tahseen, Faisal Masood, Alamdar Hussain, Uzma Majeed, Rebecca E Colman, Rehan R Syed, Antonino Catanzaro, Timothy Rodwell","doi":"10.1093/cid/ciae461","DOIUrl":"10.1093/cid/ciae461","url":null,"abstract":"<p><strong>Background: </strong>An accurate, rapid, non-sputum-based triage test for diagnosing tuberculosis (TB) is needed.</p><p><strong>Methods: </strong>A prospective evaluation of the Cepheid GeneXpert Mycobacterium tuberculosis Host Response cartridge (Xpert-MTB-HR), a prototype blood-based host response mRNA signature assay, among individuals presenting with TB-like symptoms was performed in Pakistan and results were compared to 3 reference standards: Xpert MTB/RIF Ultra, bacteriological confirmation (Xpert MTB/RIF Ultra and/or culture positivity), and composite clinical diagnosis (clinician diagnosis, treatment initiation, Xpert MTB/RIF Ultra, and/or culture positivity). Analyses were conducted both for the entire study cohort and separately in the adolescent and young adult cohort (aged 10-24 years).</p><p><strong>Results: </strong>A total of 497 participants, aged 6-83 years, returned valid Xpert-MTB-HR results. When a diagnostic threshold was set for a sensitivity of >90%, specificity was 32% (95% confidence interval [CI], 28%-37%) compared to Xpert MTB/RIF Ultra, 29% (95% CI, 25%-34%) compared to a bacteriological confirmation, and 22% (95% CI, 18%-26%) compared to a composite clinical diagnosis. However, when evaluating only the adolescent and young adult cohort with a diagnostic threshold set for sensitivity of >90%, specificity was 82% (95% CI, 74%-89%) compared to Xpert MTB/RIF Ultra, 84% (95% CI, 75%-90%) compared to a bacteriological confirmation, and 54% (95% CI, 44%-64%) compared to a composite clinical diagnosis.</p><p><strong>Conclusions: </strong>While the Xpert-MTB-HR does not meet World Health Organization minimum criteria in the general population, in our study it does meet the minimum sensitivity and specificity requirements for a non-sputum-based triage test among adolescents and young adults when compared to Xpert MTB/RIF Ultra or bacteriological confirmation.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"180-188"},"PeriodicalIF":8.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to: Nocardia Infections in Hematopoietic Cell Transplant Recipients: A Multicenter International Retrospective Study of the Infectious Diseases Working Party of the European Society for Blood and Marrow Transplantation.","authors":"","doi":"10.1093/cid/ciae606","DOIUrl":"10.1093/cid/ciae606","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"239"},"PeriodicalIF":8.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142821920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mathis Collier, Laurent Chouchana, Pierre Frange, Jeanne Sibiude, Arnold Munnich, Jean Marc Treluyer, Stéphane Blanche
{"title":"Risk of Neurodevelopmental Disorders in Children Exposed to Human Immunodeficiency Virus and Antiretrovirals In Utero: A National Cohort Study in France.","authors":"Mathis Collier, Laurent Chouchana, Pierre Frange, Jeanne Sibiude, Arnold Munnich, Jean Marc Treluyer, Stéphane Blanche","doi":"10.1093/cid/ciae610","DOIUrl":"https://doi.org/10.1093/cid/ciae610","url":null,"abstract":"<p><strong>Background: </strong>The health of children exposed but uninfected by human immunodeficiency virus (HIV) requires long-term assessment, in particular in terms of neurological and cognitive development. Numerous confounding factors have hampered such assessment, and published data are contradictory.</p><p><strong>Methods: </strong>Using data from the French National Health Data System from 2012 to 2022, we conducted a population-based matched cohort study on all live-born single children, including those born to mothers living with HIV, all prenatally exposed to antiretrovirals (ARVs). The primary outcome was the diagnosis of neurodevelopmental disorders according to the International Classification of Diseases, 10th Revision. The recourse to specialized consultations likely to indirectly reflect neurodevelopmental symptoms was also evaluated. Incidence was assessed using the Cox survival model.</p><p><strong>Results: </strong>Of 6 667 363 live-born singletons, 9035 were born to mothers with HIV, all exposed to ARVs during pregnancy. Children were followed for up to 11 years (average, 5.5 years). Overall, the incidence of neurodevelopmental disorders among exposed children was higher than in the general population, even after matching for 5 sociodemographic criteria and gestational age (hazard ratio, 1.24 [95% confidence interval, 1.04-1.47]). It was not possible to dissect the respective role of maternal infection from that of maternal treatment, as all children were coexposed to HIV and ARVs. However, among those exposed to tenofovir-emtricitabine, the ritonavir-boosted darunavir-based combination was significantly associated with a higher combined incidence of neurodevelopmental disorders and related specialized consultations than other protease inhibitors (log-rank P < .001).</p><p><strong>Conclusions: </strong>Children exposed to HIV and ARVs in utero have a higher risk of developing neurodevelopmental disorders of multifactorial origin.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":""},"PeriodicalIF":8.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143188542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Supavit Chesdachai, Larry M Baddour, Hussam Tabaja, Malini Madhavan, Nandan Anavekar, Brittany A Zwischenberger, Paola Anna Erba, Daniel C DeSimone
{"title":"Executive Summary: State-of-the-Art Review: Complexities in Cardiac Implantable Electronic Device Infections: A Contemporary Practical Approach","authors":"Supavit Chesdachai, Larry M Baddour, Hussam Tabaja, Malini Madhavan, Nandan Anavekar, Brittany A Zwischenberger, Paola Anna Erba, Daniel C DeSimone","doi":"10.1093/cid/ciae454","DOIUrl":"https://doi.org/10.1093/cid/ciae454","url":null,"abstract":"Cardiac implantable electronic device infections (CIEDIs) present substantial challenges for infectious diseases specialists, encompassing diagnosis, management, and complex decision-making involving patients, families, and multidisciplinary teams. This review, guided by a common clinical case presentation encountered in daily practice, navigates through the diagnostic process, management strategies in unique scenarios, long-term follow-up, and critical discussions required for CIEDIs.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"40 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143192134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Importance of Not Downplaying the Risks That Doxycycline Postexposure Prophylaxis Will Select for Antimicrobial Resistance.","authors":"Chris Kenyon","doi":"10.1093/cid/ciae139","DOIUrl":"10.1093/cid/ciae139","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"228-229"},"PeriodicalIF":8.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140157742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Phyo Pyae Nyein, Kathy Petoumenos, Margaret Borok, Nnakelu Eriobu, Nagalingeswaran Kumarasamy, Anchalee Avihingsanon, Iskandar Azwa, Sounkalo Dao, Mohamed Cisse, Nila J Dharan, Josh Hanson, Gail V Matthews
{"title":"Associations Between Antiretroviral Regimen and Changes in Blood Pressure: Results From the D2EFT Study.","authors":"Phyo Pyae Nyein, Kathy Petoumenos, Margaret Borok, Nnakelu Eriobu, Nagalingeswaran Kumarasamy, Anchalee Avihingsanon, Iskandar Azwa, Sounkalo Dao, Mohamed Cisse, Nila J Dharan, Josh Hanson, Gail V Matthews","doi":"10.1093/cid/ciae256","DOIUrl":"10.1093/cid/ciae256","url":null,"abstract":"<p><p>In this randomized controlled study, individuals taking dolutegravir+darunavir/ritonavir had greater increases in systolic and diastolic blood pressure than those taking 2 nucleoside reverse-transcriptase inhibitors+darunavir/ritonavir at week-48. The difference remained significant after controlling for confounding factors, including weight gain.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"160-163"},"PeriodicalIF":8.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140897585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sunish Shah, Ellen G Kline, Ghady Haidar, Kevin M Squires, Jason M Pogue, Erin K McCreary, Justin Ludwig, Lloyd G Clarke, Madison Stellfox, Daria Van Tyne, Ryan K Shields
{"title":"Rates of Resistance to Ceftazidime-Avibactam and Ceftolozane-Tazobactam Among Patients Treated for Multidrug-Resistant Pseudomonas aeruginosa Bacteremia or Pneumonia.","authors":"Sunish Shah, Ellen G Kline, Ghady Haidar, Kevin M Squires, Jason M Pogue, Erin K McCreary, Justin Ludwig, Lloyd G Clarke, Madison Stellfox, Daria Van Tyne, Ryan K Shields","doi":"10.1093/cid/ciae332","DOIUrl":"10.1093/cid/ciae332","url":null,"abstract":"<p><p>Among consecutive patients with multidrug-resistant Pseudomonas aeruginosa bacteremia or pneumonia we found those treated with ceftazidime-avibactam were more likely to develop resistance (defined as ≥4-fold increased MIC) than those treated with ceftolozane-tazobactam (40% vs 10%; P = .002). Ceftazidime-avibactam resistance was associated with new mutations in ampC and efflux regulatory pathways.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"24-28"},"PeriodicalIF":8.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141431577","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to: Cryptic Plasmodium inui and Plasmodium fieldi Infections Among Symptomatic Malaria Patients in Thailand.","authors":"","doi":"10.1093/cid/ciae618","DOIUrl":"10.1093/cid/ciae618","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"240"},"PeriodicalIF":8.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}