Marie Høst Pahus,Yu Zheng,Maxine Olefsky,Jesper Damsgaard Gunst,Pablo Tebas,Babafemi Taiwo,Ole S Søgaard,Michael J Peluso,Yolanda Lie,Jacqueline D Reeves,Christos J Petropoulos,Marina Caskey,Katharine J Bar
{"title":"Evaluation and real-world experience of a neutralization susceptibility screening assay for broadly neutralizing anti-HIV-1 antibodies.","authors":"Marie Høst Pahus,Yu Zheng,Maxine Olefsky,Jesper Damsgaard Gunst,Pablo Tebas,Babafemi Taiwo,Ole S Søgaard,Michael J Peluso,Yolanda Lie,Jacqueline D Reeves,Christos J Petropoulos,Marina Caskey,Katharine J Bar","doi":"10.1093/infdis/jiae486","DOIUrl":"https://doi.org/10.1093/infdis/jiae486","url":null,"abstract":"BACKGROUNDDevelopment of a screening assay for the clinical use of broadly neutralizing antibodies (bnAbs) is a priority for HIV therapy and cure initiatives.METHODSWe assessed the PhenoSense Monoclonal Antibody (mAb) Assay (Labcorp-Monogram Biosciences) which is CLIA-validated and has been used prospectively and retrospectively in multiple recent bnAb clinical trials.RESULTSWhen performed on pre-ART plasma and on-ART longitudinal PBMC samples sourced from a recent clinical trial, the PhenoSense mAb Assay produced robust reproducibility, concordance across sample types, and expected ranges in the susceptibility measures of bnAbs in clinical development. PhenoSense mAb applied retrospectively to baseline samples from three recent studies correlated with published laboratory-based study evaluations, but baseline bnAb susceptibility was not consistently predictive of durable virus suppression. Assessment of the feasibility of the assay in four recent clinical studies provides estimates of assay success rate and processing time.CONCLUSIONSThe PhenoSense mAb Assay provides reproducible bnAb susceptibility measurements across relevant sample types yet was not consistently predictive of virus suppression. Logistical and operational assay requirements can impact timely clinical trial conduct. These results inform bnAb studies in development.","PeriodicalId":501010,"journal":{"name":"The Journal of Infectious Diseases","volume":"194 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nathan A Ledeboer,Jane M Caldwell,Bobby L Boyanton
{"title":"Review: Diagnostic Potential for Collaborative Pharyngitis Biomarkers.","authors":"Nathan A Ledeboer,Jane M Caldwell,Bobby L Boyanton","doi":"10.1093/infdis/jiae416","DOIUrl":"https://doi.org/10.1093/infdis/jiae416","url":null,"abstract":"Pharyngitis is an inflammatory condition of the pharynx and/or tonsils commonly seen in both children and adults. Viruses and bacteria represent the most common encountered etiologic agents-yeast/fungi and parasites are infrequently implicated. Some of these are predominantly observed in unique populations (eg, immunocompromised or unvaccinated individuals). This manuscript (part 3 of 3) summarizes the current state of biomarker diagnostic testing and highlights the expanding role they will likely play in the expedited diagnosis and management of patients with acute pharyngitis. Biomarkers, in conjunction with rapid antigen and/or nucleic acid amplification testing, will likely become the standard of care to accurately diagnose the etiologic agent(s) of pharyngitis. This novel testing paradigm has the potential to guide appropriate patient management and antibiotic stewardship by accurately determining if the cause of pharyngitis is due to a viral or bacterial etiology.","PeriodicalId":501010,"journal":{"name":"The Journal of Infectious Diseases","volume":"43 1","pages":"S190-S196"},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bobby L Boyanton,Jane M Caldwell,Nathan A Ledeboer
{"title":"Review: Current Laboratory and Point-of-Care Pharyngitis Diagnostic Testing and Knowledge Gaps.","authors":"Bobby L Boyanton,Jane M Caldwell,Nathan A Ledeboer","doi":"10.1093/infdis/jiae415","DOIUrl":"https://doi.org/10.1093/infdis/jiae415","url":null,"abstract":"Pharyngitis is an inflammatory condition of the pharynx and/or tonsils commonly seen in both children and adults. Viruses and bacteria represent the most common encountered etiologic agents-yeast/fungi and parasites are infrequently implicated. Some of these are predominantly observed in unique populations (eg, immunocompromised or unvaccinated individuals). This manuscript (part 2 of 3) summarizes the current state of laboratory and point-of-care diagnostic testing and highlights the expanding role of nucleic acid amplification in the expedited diagnosis and management of patients with acute pharyngitis. It discusses preanalytical, analytical, and postanalytical variables that impact the performance of culture, rapid antigen, and nucleic acid amplification testing. Finally, it sets the stage for part 3, which discusses the emerging role of biomarkers in the management of individuals with acute pharyngitis.","PeriodicalId":501010,"journal":{"name":"The Journal of Infectious Diseases","volume":"13 1","pages":"S182-S189"},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rachel Emily Levene,John DeVincenzo,Annie L Conery,Alaa Ahmed,Yat Sun Or,Michael H J Rhodin
{"title":"EDP-938 Has a High Barrier to Resistance in Healthy Adults Experimentally Infected with Respiratory Syncytial Virus.","authors":"Rachel Emily Levene,John DeVincenzo,Annie L Conery,Alaa Ahmed,Yat Sun Or,Michael H J Rhodin","doi":"10.1093/infdis/jiae471","DOIUrl":"https://doi.org/10.1093/infdis/jiae471","url":null,"abstract":"BACKGROUNDEDP-938 is an oral once-daily RSV nucleoprotein (N) inhibitor with potent antiviral activity. In a human RSV challenge trial, EDP-938 significantly reduced viral load and symptom severity. During antiviral development, it is critical to understand the propensity for resistance to develop. In vitro studies of EDP-938 suggest a higher barrier to resistance as compared to RSV fusion inhibitors. We evaluated the development of viral resistance to EDP-938 in a human challenge trial.METHODSA subset of the 124 participants with RSV infection were chosen for genetic analysis; 159 nasal wash samples from 48 participants were analyzed using next-generation sequencing of the N gene of RSV. Of the 48 participant sampled, 37 were from EDP-938-treated and 11 were placebo-treated participants, representing 45% and 26% of the participants, respectively. The effects of treatment-emergent mutations on viral load, EDP-938 efficacy, and viral fitness were evaluated.RESULTSTwo of the 37 EDP-938-treated participants with samples sequenced had treatment-emergent mutations: N:L139I and N:E112G. From in vitro analysis, N:L139I reduced sensitivity to EDP-938 by approximately 10-fold, while N:E112G had no effect. However, N:L139I was associated with a reduction in viral fitness, suggesting clinical resistance is associated with fitness costs. Neither of these variants were associated with reduced viral clearance.CONCLUSIONSIn human RSV infections treated with EDP-938, emergence of RSV variants with reduced sensitivity to EDP-938 occurred in only 1 participant and was associated with reduced viral fitness. EDP-938's high barrier to resistance highlights its robust mechanism of action.CLINICAL TRIALS REGISTRATIONNCT03691623.","PeriodicalId":501010,"journal":{"name":"The Journal of Infectious Diseases","volume":"30 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142489794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carla N Mavian,Massimiliano S Tagliamonte,Maclean Bassett,Meer Alam,Melanie N Cash,Matt Hitchings,Rigan Louis,Alberto Riva,Kayvan Zainabadi,Marie Marcelle Deschamps,Bernard Liautaud,Vanessa Rouzier,Daniel W Fitzgerald,Jean William Pape,J Glenn Morris,Marco Salemi
{"title":"COVID-19 lineages in a minimally vaccinated island population: Genomic epidemiology of SARS-CoV-2 in Haiti.","authors":"Carla N Mavian,Massimiliano S Tagliamonte,Maclean Bassett,Meer Alam,Melanie N Cash,Matt Hitchings,Rigan Louis,Alberto Riva,Kayvan Zainabadi,Marie Marcelle Deschamps,Bernard Liautaud,Vanessa Rouzier,Daniel W Fitzgerald,Jean William Pape,J Glenn Morris,Marco Salemi","doi":"10.1093/infdis/jiae520","DOIUrl":"https://doi.org/10.1093/infdis/jiae520","url":null,"abstract":"We monitored SARS-CoV-2 variants in Haiti from 2020-2023. Despite Haitian COVID-19 travel restrictions and in the setting of a vaccination rate of 2.7%, the timing and lineage evolution of the Haiti epidemic mirrored what was occurring in the rest of the world. Sources for importation of lineages into Haiti were the United States (US), the Dominican Republic (DR), Europe, and Brazil, with exportation of lineages to the US, DR, Europe, and Asia. Viral load in patients infected by the Delta and Omicron BA.1 were correlated along the phylogenies, suggesting that higher viral loads have facilitated strain transmission and evolution.","PeriodicalId":501010,"journal":{"name":"The Journal of Infectious Diseases","volume":"63 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jane M Caldwell,Nathan A Ledeboer,Bobby L Boyanton
{"title":"Review: Known, Emerging, and Remerging Pharyngitis Pathogens.","authors":"Jane M Caldwell,Nathan A Ledeboer,Bobby L Boyanton","doi":"10.1093/infdis/jiae391","DOIUrl":"https://doi.org/10.1093/infdis/jiae391","url":null,"abstract":"Pharyngitis is an inflammatory condition of the pharynx and/or tonsils commonly seen in both children and adults. Viruses and bacteria represent the most common encountered etiologic agents-yeast/fungi and parasites are infrequently implicated. Some of these are predominantly observed in unique populations (eg, immunocompromised or unvaccinated individuals). This article (part 1 of 3) summarizes the impact of acute pharyngitis on the health care system and reviews the etiologic agents of acute pharyngitis, including both emerging and reemerging pathogens that health care providers should consider when evaluating their patients. Finally, it sets the stage for parts 2 and 3, which discuss the current and evolving state of diagnostic testing for acute pharyngitis.","PeriodicalId":501010,"journal":{"name":"The Journal of Infectious Diseases","volume":"4 1","pages":"S173-S181"},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hong Yu, William M Geisler, Chuanbin Dai, Kanupriya Gupta, Gary Cutter, Robert C Brunham
{"title":"Neutralizing Antibody Responses to Chlamydia trachomatis in Women and Associations with Chlamydia Outcomes","authors":"Hong Yu, William M Geisler, Chuanbin Dai, Kanupriya Gupta, Gary Cutter, Robert C Brunham","doi":"10.1093/infdis/jiae519","DOIUrl":"https://doi.org/10.1093/infdis/jiae519","url":null,"abstract":"We assessed neutralizing antibody responses in a well-characterized cohort of 60 women with different Chlamydia trachomatis infection outcomes noted at a treatment visit and 3-month follow-up. We found varying rates of neutralization (inhibition of C. trachomatis) in sera at different dilution levels and varying neutralizing antibody titers across outcomes. Median neutralization rates were significantly higher in sera at high dilutions (1:320-1:1280) from women with spontaneous resolution versus persisting infection before treatment (all P< .05). These findings suggest that neutralizing antibody responses may contribute to protective immunity against chlamydia.","PeriodicalId":501010,"journal":{"name":"The Journal of Infectious Diseases","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142487233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Serena Maria Dib, Sonia Tandon Wimalasena, Daniel S Graciaa, Nadine Rouphael
{"title":"Systems Vaccinology: Navigating the Future of Personalized Immunity and Next Generation Vaccines","authors":"Serena Maria Dib, Sonia Tandon Wimalasena, Daniel S Graciaa, Nadine Rouphael","doi":"10.1093/infdis/jiae505","DOIUrl":"https://doi.org/10.1093/infdis/jiae505","url":null,"abstract":"Systems vaccinology integrates a range of \"omics\" technologies to identify key immune signatures and enhance vaccine development. This approach aids in understanding variations in immune responses, driven by genetics, health status, and microbiome. Consequently, systems vaccinology helps pave the way for personalized vaccination strategies, essential for addressing diverse populations.","PeriodicalId":501010,"journal":{"name":"The Journal of Infectious Diseases","volume":"124 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Massage Therapists (Sex Workers) and Mpox in the Philippines.","authors":"Dalmacito A Cordero","doi":"10.1093/infdis/jiae517","DOIUrl":"https://doi.org/10.1093/infdis/jiae517","url":null,"abstract":"","PeriodicalId":501010,"journal":{"name":"The Journal of Infectious Diseases","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Broadening the Global Mpox Response: A Critical Reflection on Vulnerable Populations.","authors":"Yusuff Adebayo Adebisi","doi":"10.1093/infdis/jiae518","DOIUrl":"https://doi.org/10.1093/infdis/jiae518","url":null,"abstract":"","PeriodicalId":501010,"journal":{"name":"The Journal of Infectious Diseases","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142449269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}