Prasad S Kulkarni, Anand Kawade, Sunil Kohli, Renuka Munshi, Chetna Maliye, Nithya J Gogtay, Ravish H S, Kiranjit Singh, K Vengadakrishnan, Sandeep Kumar Panigrahi, Jyotiranjan Sahoo, Ashish Bavdekar, B S Garg, Abhishek Raut, Jeffrey P Raj, Unnati Saxena, Vijaya L Chaudhari, Rakesh Patil, Epari Venkatarao, Nitu Kumari, Dhananjay Kapse
{"title":"Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study","authors":"Prasad S Kulkarni, Anand Kawade, Sunil Kohli, Renuka Munshi, Chetna Maliye, Nithya J Gogtay, Ravish H S, Kiranjit Singh, K Vengadakrishnan, Sandeep Kumar Panigrahi, Jyotiranjan Sahoo, Ashish Bavdekar, B S Garg, Abhishek Raut, Jeffrey P Raj, Unnati Saxena, Vijaya L Chaudhari, Rakesh Patil, Epari Venkatarao, Nitu Kumari, Dhananjay Kapse","doi":"10.1016/s1473-3099(24)00576-0","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00576-0","url":null,"abstract":"<h3>Background</h3>Meningococcal disease remains an important public health problem globally. We assessed the non-inferiority and the lot-to-lot consistency of a pentavalent meningococcal ACYWX conjugate vaccine (NmCV-5; Serum Institute of India, Pune, India) versus a quadrivalent meningococcal ACWY conjugate vaccine (MenACWY-D) in healthy adults.<h3>Methods</h3>In this observer-blind, randomised, active-controlled, phase 2/3 study, healthy adults aged 18–85 years were recruited from nine hospitals across seven cities in India. Participants were grouped by age (age 18–29, 30–60, and 61–85 years), and within each age group they were randomly assigned (3:1) to receive either NmCV-5 or MenACWY-D (Sanofi Pasteur). In the age 18–29 years group, participants were additionally randomly assigned (1:1:1:1) to either lot A, lot B, or lot C of NmCV-5 or MenACWY-D. Block randomisation was used (block sizes of 4, 8, and 12). Study participants and study personnel were masked to treatment assignment. Participants received either a 0·5 mL dose of NmCV-5, containing 5 μg each of conjugated A, C, W, Y, and X polysaccharides, or 0·5 mL MenACWY-D, containing 4 μg of each of conjugated A, C, W, and Y polysaccharides. Vaccinations were administered intramuscularly in the deltoid muscle. The primary outcomes were seroresponse (non-inferiority margin of –10%) and geometric mean titres (GMTs; non-inferiority margin of 0·5) in all participants, and lot-to-lot consistency of NmCV-5 (in participants aged 18–29 years; consistency was shown if the geometric mean ratio [GMR] 95% CIs were within the limit interval of 0·5 to 2). For non-inferiority, serogroup X immune response in the NmCV-5 group was compared with the lowest immune response among serogroups A, C, W, and Y in the MenACWY-D group. Immunogenicity was assessed with a serum bactericidal activity assay that used baby rabbit serum as the complement (rSBA) on days 1 and 29 in the modified per-protocol population (including all participants who were randomly assigned, received vaccine, had a post-vaccination rSBA measurement up to 121 days after vaccination, and no major protocol violations). Solicited events were collected for 7 days and serious adverse events were collected for 180 days, and assessed in the safety population (all participants who received vaccination). This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT04358731</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, and CTRI, CTRI/2019/12/022436, and is now complete.<h3>Findings</h3>Between Dec 27, 2019, and Sept 19, 2020, 1712 individuals were screened, of whom 1","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":56.3,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594327","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 Lancet Infect Dis 2024; published online October 7. https://doi.org/10.1016/S1473-3099(24)00561-9","authors":"","doi":"10.1016/s1473-3099(24)00743-6","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00743-6","url":null,"abstract":"<em>Heil EL, McCreary EK. REVISITing treatment of metallo-</em>β-lactamases. Lancet Infect Dis <em>2024; published online Oct 7. https://doi.org/10.1016/S1473-3099(24)00561-9</em>—In this Comment, two corrections have been made. The correct treatment difference for clinical cure rate at the test-of-cure visit is 2·7% (95% CI –6·6 to 12·4). The loading dose for aztreonam–avibactam was clarified to state it was how the drug was administered in the REVISIT trial. These corrections have been made to the online version as of Nov 6, 2024, and the printed version will be correct..","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":56.3,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594292","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":"A step closer to elimination of meningococcal disease","authors":"Michelle Clarke, Helen S Marshall","doi":"10.1016/s1473-3099(24)00622-4","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00622-4","url":null,"abstract":"No Abstract","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":56.3,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142594293","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}
Samuel W Mackrill, David C Schramm, Ali Amini, Riina Rautemaa-Richardson, Nicola Jones, Matthew O Brook, Katie Jeffery, Alexander J Mentzer
{"title":"A case of disseminated autochthonous Cladophialophora bantiana infection in a renal transplant recipient in the UK","authors":"Samuel W Mackrill, David C Schramm, Ali Amini, Riina Rautemaa-Richardson, Nicola Jones, Matthew O Brook, Katie Jeffery, Alexander J Mentzer","doi":"10.1016/s1473-3099(24)00579-6","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00579-6","url":null,"abstract":"Disease associated with <em>Cladophialophora bantiana</em> infection is uncommon but can be characterised by severe and life-threatening CNS involvement. Diagnosis is challenging due to both the infection's rarity and non-specific clinical presentation, which can mimic malignancy and infection caused by more common organisms. Transmission can occur via inhalation or inoculation through compromised skin, followed by haematogenous dissemination to the brain and other organs. We report a case of a 42-year-old renal transplant recipient with no travel history presenting with neurological symptoms and skin and lung lesions due to <em>C bantiana</em> infection. An aggressive treatment approach comprising combination antifungal therapy, surgical debridement, and withdrawal of immunosuppression resulted in disease control, although this treatment was complicated by voriconazole-induced skeletal fluorosis. This organism, more commonly encountered in tropical regions, has traditionally been considered imported into the UK by returning travellers, therefore this case of autochthonous infection could reflect an expanding range alongside global climactic shifts.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":56.3,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142588331","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 Lancet Infect Dis 2024; published online Oct 10. https://doi.org/10.1016/S1473-3099(24)00507-3","authors":"","doi":"10.1016/s1473-3099(24)00732-1","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00732-1","url":null,"abstract":"<em>Babiker A, Warner S, Li X, et al. Adjunctive linezolid versus clindamycin for toxin inhibition in</em> β<em>-lactam-treated patients with invasive group A streptococcal infections in 195 US hospitals from 2016 to 2021: a retrospective cohort study with target trial emulation.</em> Lancet Infect Dis <em>2024; published online Oct 10. https://doi.org/10.1016/S1473-3099(24)00507-3</em>—In this Article, the members of the NIH-Antimicrobial Resistance Outcomes Research Initiative have been updated. This correction has been made to the online version as of Nov 4, 2024 and will be made to the printed version.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":56.3,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142579899","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}
Kristine A Moore, Julia T Ostrowsky, Angela J Mehr, Rebecca A Johnson, Angela K Ulrich, Nicolina M Moua, Petra C Fay, Peter J Hart, Josephine P Golding, Virginia Benassi, Marie-Pierre Preziosi, Ifedayo M Adetifa, George O Akpede, William K Ampofo, Danny A Asogun, Alan D T Barrett, Daniel G Bausch, Ilse de Coster, Devy M Emperador, Heinz Feldmann, Elisabeth Fichet-Calvet, Pierre B H Formenty, Robert F Garry, Donald S Grant, Stephan Günther, Swati B Gupta, Marie Jaspard, Laura T Mazzola, Sylvanus A Okogbenin, Cathy Roth, Connie S Schmaljohn, Michael T Osterholm
{"title":"Lassa fever research priorities: towards effective medical countermeasures by the end of the decade.","authors":"Kristine A Moore, Julia T Ostrowsky, Angela J Mehr, Rebecca A Johnson, Angela K Ulrich, Nicolina M Moua, Petra C Fay, Peter J Hart, Josephine P Golding, Virginia Benassi, Marie-Pierre Preziosi, Ifedayo M Adetifa, George O Akpede, William K Ampofo, Danny A Asogun, Alan D T Barrett, Daniel G Bausch, Ilse de Coster, Devy M Emperador, Heinz Feldmann, Elisabeth Fichet-Calvet, Pierre B H Formenty, Robert F Garry, Donald S Grant, Stephan Günther, Swati B Gupta, Marie Jaspard, Laura T Mazzola, Sylvanus A Okogbenin, Cathy Roth, Connie S Schmaljohn, Michael T Osterholm","doi":"10.1016/S1473-3099(24)00229-9","DOIUrl":"10.1016/S1473-3099(24)00229-9","url":null,"abstract":"<p><p>In 2016, WHO designated Lassa fever a priority disease for epidemic preparedness as part of the WHO Blueprint for Action to Prevent Epidemics. One aspect of preparedness is to promote development of effective medical countermeasures (ie, diagnostics, therapeutics, and vaccines) against Lassa fever. Diagnostic testing for Lassa fever has important limitations and key advancements are needed to ensure rapid and accurate diagnosis. Additionally, the only treatment available for Lassa fever is ribavirin, but controversy exists regarding its effectiveness. Finally, no licensed vaccines are available for the prevention and control of Lassa fever. Ongoing epidemiological and behavioural studies are also crucial in providing actionable information for medical countermeasure development, use, and effectiveness in preventing and treating Lassa fever. This Personal View provides current research priorities for development of Lassa fever medical countermeasures based on literature published primarily in the last 5 years and consensus opinion of 20 subject matter experts with broad experience in public health or the development of diagnostics, therapeutics, and vaccines for Lassa fever. These priorities provide an important framework to ensure that Lassa fever medical countermeasures are developed and readily available for use in endemic and at-risk areas by the end of the decade.</p>","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141535784","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}
Kasra Shirini, Shani Kamberi, Cynthia Drachenberg, Abdolreza Haririan, Kapil Saharia, Raphael P H Meier
{"title":"Renal transplantation using kidneys from a donor with high grade cytomegalovirus viraemia: case report and literature review.","authors":"Kasra Shirini, Shani Kamberi, Cynthia Drachenberg, Abdolreza Haririan, Kapil Saharia, Raphael P H Meier","doi":"10.1016/S1473-3099(24)00359-1","DOIUrl":"10.1016/S1473-3099(24)00359-1","url":null,"abstract":"<p><p>Transplanting organs from cytomegalovirus-seropositive donors into cytomegalovirus-seronegative recipients is an accepted practice. However, outcomes following transplantation of organs from donors with active cytomegalovirus disease are unknown. We present a case involving a patient aged 61 years with end-stage renal disease, seropositive for cytomegalovirus, who underwent dual kidney transplant from a donor with high-grade cytomegalovirus viraemia. The donor was on immunosuppressive therapy for systemic lupus erythematosus and interstitial lung disease and had been admitted with respiratory failure. The donor had high-grade cytomegalovirus viraemia with probable cytomegalovirus pneumonitis (cytomegalovirus viral load >100 000 international units [IU]/mL in plasma and 319 000 IU/mL in bronchoalveolar lavage). Renal biopsy at organ procurement showed the absence of cytomegalovirus inclusions. Following transplantation, the recipient had delayed graft function, with renal recovery after 1 week. The patient received basiliximab induction and standard tacrolimus-based maintenance immunosuppression. He received ganciclovir and valganciclovir treatment for 1 month, followed by valganciclovir prophylaxis (or viral load monitoring, when prophylaxis had to be paused) for 2 additional months to prevent donor-derived cytomegalovirus infection. Transient cytomegalovirus viraemia (peaking at 4480 IU/mL) developed at 4 months and resolved with 1 month of valganciclovir treatment. The patient is doing well 1 year after transplantation, with adequate kidney function. This case highlights the successful and safe transplantation of kidneys from a donor with cytomegalovirus disease into a cytomegalovirus-seropositive recipient. Further research is needed to confirm our findings and define post-transplantation management.</p>","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141591883","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":"A model of vector-targeted interventions for visceral leishmaniasis.","authors":"Christine Petersen","doi":"10.1016/S1473-3099(24)00488-2","DOIUrl":"10.1016/S1473-3099(24)00488-2","url":null,"abstract":"","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":36.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141972151","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}