Pub Date : 2025-02-06DOI: 10.1016/j.jinf.2025.106439
Chang Song , Chun-Yan Zhao , Kai Li , Yan-Rong Lin, Shu-Lin Song, Chao-Yan Xu, Hang-Biao Qiang, Zhou-Hua Xie, Qing-Dong Zhu
{"title":"A 2.5D transfer deep learning model based on artificial intelligence for differentiating lymphoma and tuberculous lymphadenitis in HIV/AIDS patients","authors":"Chang Song , Chun-Yan Zhao , Kai Li , Yan-Rong Lin, Shu-Lin Song, Chao-Yan Xu, Hang-Biao Qiang, Zhou-Hua Xie, Qing-Dong Zhu","doi":"10.1016/j.jinf.2025.106439","DOIUrl":"10.1016/j.jinf.2025.106439","url":null,"abstract":"","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"90 3","pages":"Article 106439"},"PeriodicalIF":14.3,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-05DOI: 10.1016/j.jinf.2025.106435
Oliver A. Cornely , Hervé Dupont , Malgorzata Mikulska , Riina Rautemaa-Richardson , Carolina Garcia-Vidal , George R. Thompson III , Martin Hoenigl
Achieving and maintaining therapeutic drug exposures with antifungals can be challenging in special patient populations, such as those with organ dysfunction (liver or kidney) or obesity, or elderly patients, due to dose–exposure relationships and potential drug–drug interactions. Dose adjustments may be needed in these populations to maintain therapeutic efficacy and/or prevent toxicity. We reviewed specific dosing considerations for antifungals in special populations with candidaemia and/or invasive candidiasis, focusing on those relating to echinocandins (based on prescribing information), and then explored the utility of the second-generation echinocandin rezafungin in treating these populations (based on currently available data identified from a PubMed and congress abstract search). Available data showed that echinocandins may sometimes require dosing modifications for special populations with candidaemia/invasive candidiasis, primarily due to decreases in pharmacokinetic exposures. Rezafungin appears to be suitable for use in a variety of special populations without the need for dose modifications based on available data, including patients with organ dysfunction or obesity, and elderly and critically ill patients. Further research is needed in populations where rezafungin data are not available including children, people living with HIV, patients receiving extracorporeal membrane oxygenation and those with underlying neurological conditions.
{"title":"Rezafungin in special populations with candidaemia and/or invasive candidiasis","authors":"Oliver A. Cornely , Hervé Dupont , Malgorzata Mikulska , Riina Rautemaa-Richardson , Carolina Garcia-Vidal , George R. Thompson III , Martin Hoenigl","doi":"10.1016/j.jinf.2025.106435","DOIUrl":"10.1016/j.jinf.2025.106435","url":null,"abstract":"<div><div>Achieving and maintaining therapeutic drug exposures with antifungals can be challenging in special patient populations, such as those with organ dysfunction (liver or kidney) or obesity, or elderly patients, due to dose–exposure relationships and potential drug–drug interactions. Dose adjustments may be needed in these populations to maintain therapeutic efficacy and/or prevent toxicity. We reviewed specific dosing considerations for antifungals in special populations with candidaemia and/or invasive candidiasis, focusing on those relating to echinocandins (based on prescribing information), and then explored the utility of the second-generation echinocandin rezafungin in treating these populations (based on currently available data identified from a PubMed and congress abstract search). Available data showed that echinocandins may sometimes require dosing modifications for special populations with candidaemia/invasive candidiasis, primarily due to decreases in pharmacokinetic exposures. Rezafungin appears to be suitable for use in a variety of special populations without the need for dose modifications based on available data, including patients with organ dysfunction or obesity, and elderly and critically ill patients. Further research is needed in populations where rezafungin data are not available including children, people living with HIV, patients receiving extracorporeal membrane oxygenation and those with underlying neurological conditions.</div></div>","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"90 3","pages":"Article 106435"},"PeriodicalIF":14.3,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-02DOI: 10.1016/j.jinf.2025.106433
Anne Cathrine Zimakoff , Andreas Jensen , Michelle Malon , Jesper Kiehn Sørensen , Dorthe Maria Vittrup , Signe Kjeldgaard Jensen , Emma Therese Bay , Jannet Svensson , Lone Graff Stensballe
Background
In observational studies, childhood vaccinations have been associated with atopic diseases. However, results are conflicting and evidence from randomised trials is lacking.
Methods
Atopic disease after interventional measles-mumps-rubella (MMR) vaccine was a pre-planned secondary outcome of the MMR trial, a randomised, double-blind, placebo-controlled trial in 6540 Danish infants in the high-income setting of Denmark. At two hospitals, infants 5–7 months of age were randomly assigned 1:1 to receive an intramuscular injection with M-M-R VaxPro or placebo (solvent only). Randomisation was stratified by site, sex, and prematurity (< 37 weeks of gestation). The infants were followed up in the Danish health registries to detect eczema, asthma-like disease, and allergic rhinoconjunctivitis, the composite outcome of the three diseases being the primary endpoint of the present study.
The trial was registered in the EU Clinical Trials Registry (2016-001901-18) and ClinicalTrials.gov (NTC03780179).
Findings
Between April 2019 and October 2021, 6540 infants were randomised (3266 MMR and 3274 placebo). There was no difference in the rate of atopic disease before 12 months of age between the MMR and placebo group (76 events MMR vs. 77 placebo), resulting in a hazard ratio of 0·98 (95% confidence interval 0·72 to 1·35). Secondary analyses with follow-up until 24 months of age yielded essentially identical results.
Interpretation
Based on trial data in 6540 Danish infants randomised to MMR or placebo at 5–7 months, no association between MMR and atopic disease in early childhood was observed.
{"title":"Measles-mumps-rubella vaccination at 6 months of age and the risk of atopic disease in the first year of life: Results from a Danish placebo-controlled randomised trial","authors":"Anne Cathrine Zimakoff , Andreas Jensen , Michelle Malon , Jesper Kiehn Sørensen , Dorthe Maria Vittrup , Signe Kjeldgaard Jensen , Emma Therese Bay , Jannet Svensson , Lone Graff Stensballe","doi":"10.1016/j.jinf.2025.106433","DOIUrl":"10.1016/j.jinf.2025.106433","url":null,"abstract":"<div><h3>Background</h3><div>In observational studies, childhood vaccinations have been associated with atopic diseases. However, results are conflicting and evidence from randomised trials is lacking.</div></div><div><h3>Methods</h3><div>Atopic disease after interventional measles-mumps-rubella (MMR) vaccine was a pre-planned secondary outcome of the MMR trial, a randomised, double-blind, placebo-controlled trial in 6540 Danish infants in the high-income setting of Denmark. At two hospitals, infants 5–7 months of age were randomly assigned 1:1 to receive an intramuscular injection with M-M-R VaxPro or placebo (solvent only). Randomisation was stratified by site, sex, and prematurity (< 37 weeks of gestation). The infants were followed up in the Danish health registries to detect eczema, asthma-like disease, and allergic rhinoconjunctivitis, the composite outcome of the three diseases being the primary endpoint of the present study.</div><div>The trial was registered in the EU Clinical Trials Registry (2016-001901-18) and ClinicalTrials.gov (NTC03780179).</div></div><div><h3>Findings</h3><div>Between April 2019 and October 2021, 6540 infants were randomised (3266 MMR and 3274 placebo). There was no difference in the rate of atopic disease before 12 months of age between the MMR and placebo group (76 events MMR vs. 77 placebo), resulting in a hazard ratio of 0·98 (95% confidence interval 0·72 to 1·35). Secondary analyses with follow-up until 24 months of age yielded essentially identical results.</div></div><div><h3>Interpretation</h3><div>Based on trial data in 6540 Danish infants randomised to MMR or placebo at 5–7 months, no association between MMR and atopic disease in early childhood was observed.</div></div>","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"90 3","pages":"Article 106433"},"PeriodicalIF":14.3,"publicationDate":"2025-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143191359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.jinf.2024.106392
Anna A. Mensah , Julia Stowe , Kevin Brown , Jamie LopezBernal , Shamez Ladhani , Nick Andrews , Helen Campbell
Background
Disease severity and pregnancy outcomes following SARS-CoV-2 reinfections in pregnancy are not well understood.
Methods
We linked women aged 18 to 50 years testing positive in the community for COVID-19 between April 2021 and March 2022 to hospital, vaccine and maternal services databases. We compared hospital and intensive care unit (ICU) admission rates following infection and reinfection in pregnant and non-pregnant women, and low birthweight, prematurity and stillbirth in women infected and reinfected during pregnancy.
Results
We identified 68,842 pregnant and 3,915,069 infected non-pregnant women. Hospital admission after SARS-CoV-2 reinfection was more common in pregnancy, especially during the third trimester (aOR= 18.56; 95% CI: 9.46 - 36.42) and was similar following reinfection or primary infection in pregnancy (aOR= 0.82; 95% CI: 0.50 - 1.33). All ICU admissions (n=49) in pregnancy occurred after primary infection with delta. There was no notable difference in adverse pregnancy outcomes after primary infection or reinfection with SARS-CoV-2 during pregnancy.
Conclusion
Pregnant women remain at higher risk of more severe disease during reinfection compared to non-pregnant women yet; hospitalisation and ICU admissions risk were low during the omicron period. The virulence of circulating variants needs to be assessed to guide maternal COVID-19 vaccination programmes against.
{"title":"COVID-19 reinfection in pregnancy: Assessment of severity and pregnancy outcomes in England","authors":"Anna A. Mensah , Julia Stowe , Kevin Brown , Jamie LopezBernal , Shamez Ladhani , Nick Andrews , Helen Campbell","doi":"10.1016/j.jinf.2024.106392","DOIUrl":"10.1016/j.jinf.2024.106392","url":null,"abstract":"<div><h3>Background</h3><div>Disease severity and pregnancy outcomes following SARS-CoV-2 reinfections in pregnancy are not well understood.</div></div><div><h3>Methods</h3><div>We linked women aged 18 to 50 years testing positive in the community for COVID-19 between April 2021 and March 2022 to hospital, vaccine and maternal services databases. We compared hospital and intensive care unit (ICU) admission rates following infection and reinfection in pregnant and non-pregnant women, and low birthweight, prematurity and stillbirth in women infected and reinfected during pregnancy.</div></div><div><h3>Results</h3><div>We identified 68,842 pregnant and 3,915,069 infected non-pregnant women. Hospital admission after SARS-CoV-2 reinfection was more common in pregnancy, especially during the third trimester (aOR= 18.56; 95% CI: 9.46 - 36.42) and was similar following reinfection or primary infection in pregnancy (aOR= 0.82; 95% CI: 0.50 - 1.33). All ICU admissions (n=49) in pregnancy occurred after primary infection with delta. There was no notable difference in adverse pregnancy outcomes after primary infection or reinfection with SARS-CoV-2 during pregnancy.</div></div><div><h3>Conclusion</h3><div>Pregnant women remain at higher risk of more severe disease during reinfection compared to non-pregnant women yet; hospitalisation and ICU admissions risk were low during the omicron period. The virulence of circulating variants needs to be assessed to guide maternal COVID-19 vaccination programmes against.</div></div>","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"90 2","pages":"Article 106392"},"PeriodicalIF":14.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142903814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.jinf.2024.106401
Samaneh Moallemi , Nicodemus Tedla , Chathurani Sigera , Praveen Weeratunga , Deepika Fernando , Senaka Rajapakse , Andrew R. Lloyd , Chaturaka Rodrigo
Background
Dengue, a mosquito-borne viral infection, poses a rapidly growing burden, particularly in low- and middle-income countries. Without early identification of patients at risk of severe outcomes (dengue haemorrhagic fever, severe dengue, and plasma leakage- the latter typically occurring on days 5–7 of illness), untriaged admissions lead to hospital overcrowding and suboptimal care.
Methods
This nested case-control study compared early-stage plasma samples (within the first 96 hours of fever) from dengue patients with and without plasma leakage. Thirty-four potential biomarkers, selected through systematic review, were tested on a multiplex bead-based immunoassay platform. Subgroup analysis stratified patients by primary or secondary dengue infection.
Findings
A total of 228 patient samples (114 had plasma leakage) were tested. Elevated Vascular cell adhesion molecule-1 (OR:3.289, 95% CI: 1.090–9.926, p<0.05), and Interleukin 33 receptor levels (OR: 2.677, 95% CI: 1.244–5.856, p<0.05) were associated with an increased risk of plasma leakage while eotaxin-1 was associated with a decreased risk (OR: 0.166, 95% CI: 0.057–0.483, p<0.05). When adjusted for prior dengue exposure, additional biomarkers (C-X-C motif chemokine 11, serum amyloid A) were also associated with plasma leakage.
Interpretation
Plasma leakage in dengue, being more objectively measurable than other severe outcomes, offers a reliable endpoint for biomarker studies. Identifying biomarkers that predict plasma leakage strengthens the evidence base in dengue research. These biomarkers could improve clinical assessment and patient care in dengue cases.
{"title":"Early circulating biomarkers to predict plasma leakage in dengue fever","authors":"Samaneh Moallemi , Nicodemus Tedla , Chathurani Sigera , Praveen Weeratunga , Deepika Fernando , Senaka Rajapakse , Andrew R. Lloyd , Chaturaka Rodrigo","doi":"10.1016/j.jinf.2024.106401","DOIUrl":"10.1016/j.jinf.2024.106401","url":null,"abstract":"<div><h3>Background</h3><div>Dengue, a mosquito-borne viral infection, poses a rapidly growing burden, particularly in low- and middle-income countries. Without early identification of patients at risk of severe outcomes (dengue haemorrhagic fever, severe dengue, and plasma leakage- the latter typically occurring on days 5–7 of illness), untriaged admissions lead to hospital overcrowding and suboptimal care.</div></div><div><h3>Methods</h3><div>This nested case-control study compared early-stage plasma samples (within the first 96 hours of fever) from dengue patients with and without plasma leakage. Thirty-four potential biomarkers, selected through systematic review, were tested on a multiplex bead-based immunoassay platform. Subgroup analysis stratified patients by primary or secondary dengue infection.</div></div><div><h3>Findings</h3><div>A total of 228 patient samples (114 had plasma leakage) were tested. Elevated Vascular cell adhesion molecule-1 (OR:3.289, 95% CI: 1.090–9.926, p<0.05), and Interleukin 33 receptor levels (OR: 2.677, 95% CI: 1.244–5.856, p<0.05) were associated with an increased risk of plasma leakage while eotaxin-1 was associated with a decreased risk (OR: 0.166, 95% CI: 0.057–0.483, p<0.05). When adjusted for prior dengue exposure, additional biomarkers (C-X-C motif chemokine 11, serum amyloid A) were also associated with plasma leakage.</div></div><div><h3>Interpretation</h3><div>Plasma leakage in dengue, being more objectively measurable than other severe outcomes, offers a reliable endpoint for biomarker studies. Identifying biomarkers that predict plasma leakage strengthens the evidence base in dengue research. These biomarkers could improve clinical assessment and patient care in dengue cases.</div></div>","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"90 2","pages":"Article 106401"},"PeriodicalIF":14.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142933422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.jinf.2024.106405
Anselm Jorda , Marlene Prager , Lena Pracher , Patrick Haselwanter , Matthias Jackwerth , Valentin al Jalali , Erdem Yildiz , Amelie Leutzendorff , Maria Weber , Schermin Yourieva , Paula Kammerer , Theresa Pecho , Alice Decaminada , Lena Ederer , Ursula Wiedermann , Lukas Weseslindtner , Monika Redlberger-Fritz , Felix Bergmann , Markus Zeitlinger
Objectives
There is conflicting evidence as to whether the combined administration of two vaccines can lead to poorer immunogenicity and reactogenicity. The co-administration of the Omicron-adapted COVID-19 vaccine from Novavax (NVX-CoV2601) and a 20-valent pneumococcal conjugate vaccine (PCV20) has not been previously investigated.
Methods
In this randomised, double-blind, placebo-controlled, non-inferiority trial, immunocompetent participants aged ≥60 years were randomised in a 1:1:1:1 ratio to four groups: NVX-CoV2601 plus PCV20 (combination group); NVX-CoV2601 plus placebo (NVX-only group); PCV20 plus placebo (PCV20-only group); or placebo plus placebo (placebo group). The primary outcome was Omicron-specific anti-spike protein IgG ELISA units at day 28 in the combination group compared with the NVX-only group. Non-inferiority was established if the lower limit of the two-sided 95% CI of the geometric mean titre ratio was above the non-inferiority margin of 0.67. Secondary outcomes included anti-pneumococcal capsular polysaccharide (PCP) IgG ELISA units. Solicited local and systemic adverse events were collected for 7 days after vaccination. This study was registered with ClinicalTrials.gov, number NCT05767606, and the EU Clinical Trials Register, EudraCT number 2022–004118-12.
Results
All 256 randomised participants completed the study. The baseline characteristics were similar in the four groups. Overall, the median age was 64 (IQR 61 to 69) and 105 (41%) of 256 were male. At day 28, the geometric mean anti-spike protein IgG ELISA units were 534 U/mL (95% CI 432–660) in the combination group and 556 U/mL (95% CI 460–672) in the NVX-only group, resulting in a geometric mean titre ratio of 0.96 (95% CI 0.73–1.27), thereby meeting the criteria for non-inferiority.
Anti-PCP IgG ELISA units at day 28 were 507 U/mL (95% CI 416–619) in the combination group and 592 U/mL (95% CI 485–723) in the PCV20-only group. Local and systemic reactogenicity was similar in the three active treatment groups. No safety concerns or serious adverse events were observed.
Conclusions
Immunogenicity following co-administration of NVX-CoV2601 with PCV20 was non-inferior to administration of NVX-CoV2601 alone. Given the similar safety and reactogenicity profile, our findings may help to overcome concerns about concomitant vaccination and pave the way for combination vaccines.
Funding
Novavax.
目的:关于联合接种两种疫苗是否会导致较差的免疫原性和反应原性,目前存在相互矛盾的证据。此前尚未对 Novavax 公司生产的 Omicron 适应型 COVID-19 疫苗(NVX-CoV2601)和 20 价肺炎球菌结合疫苗(PCV20)的联合接种进行过研究:在这项随机、双盲、安慰剂对照、非劣效性试验中,年龄≥60岁的免疫功能正常者按1:1:1:1的比例被随机分为四组:NVX-CoV2601加PCV20(联合组);NVX-CoV2601加安慰剂(仅NVX组);PCV20加安慰剂(仅PCV20组);或安慰剂加安慰剂(安慰剂组)。主要结果是,与纯 NVX 组相比,联合组在第 28 天时的 Omicron 特异性抗尖头蛋白 IgG ELISA 单位。如果几何平均滴度比的双侧 95% CI 的下限高于 0.67 的非劣效边际,则确定为非劣效性。次要结果包括抗肺炎球菌球囊多糖(PCP)IgG ELISA 单位。疫苗接种后 7 天内收集了局部和全身不良反应。该研究已在 ClinicalTrials.gov 注册,注册号为 NCT05767606,并在欧盟临床试验注册中心注册,注册号为 EudraCT 2022-004118-12:所有 256 名随机参与者均完成了研究。四组参与者的基线特征相似。总体而言,中位年龄为 64 岁(IQR 61 至 69),256 名参与者中有 105 名男性(41%)。第28天时,联合组的几何平均抗尖峰蛋白IgG ELISA单位为534U/mL(95% CI 432-660),纯NVX组为556U/mL(95% CI 460-672),几何平均滴度比为0.96(95% CI 0.73-1.27),因此符合非劣效性标准。第28天时,联合组的抗五氯酚钠IgG ELISA单位为507U/mL(95% CI 416-619),纯PCV20组为592U/mL(95% CI 485-723)。三个活性治疗组的局部和全身反应性相似。未发现安全问题或严重不良事件:结论:NVX-CoV2601与PCV20联合用药后的免疫原性并不比单独使用NVX-CoV2601差。考虑到相似的安全性和致病反应,我们的研究结果可能有助于克服对同时接种疫苗的担忧,并为联合疫苗的开发铺平道路:Novavax.
{"title":"Immunogenicity, safety, and reactogenicity of concomitant administration of the novavax vaccine against Omicron XBB.1.5 (NVX-CoV2601) and a 20-valent pneumococcal conjugate vaccine in adults aged ≥60 years: A randomised, double-blind, placebo-controlled, non-inferiority trial","authors":"Anselm Jorda , Marlene Prager , Lena Pracher , Patrick Haselwanter , Matthias Jackwerth , Valentin al Jalali , Erdem Yildiz , Amelie Leutzendorff , Maria Weber , Schermin Yourieva , Paula Kammerer , Theresa Pecho , Alice Decaminada , Lena Ederer , Ursula Wiedermann , Lukas Weseslindtner , Monika Redlberger-Fritz , Felix Bergmann , Markus Zeitlinger","doi":"10.1016/j.jinf.2024.106405","DOIUrl":"10.1016/j.jinf.2024.106405","url":null,"abstract":"<div><h3>Objectives</h3><div>There is conflicting evidence as to whether the combined administration of two vaccines can lead to poorer immunogenicity and reactogenicity. The co-administration of the Omicron-adapted COVID-19 vaccine from Novavax (NVX-CoV2601) and a 20-valent pneumococcal conjugate vaccine (PCV20) has not been previously investigated.</div></div><div><h3>Methods</h3><div>In this randomised, double-blind, placebo-controlled, non-inferiority trial, immunocompetent participants aged ≥60 years were randomised in a 1:1:1:1 ratio to four groups: NVX-CoV2601 plus PCV20 (combination group); NVX-CoV2601 plus placebo (NVX-only group); PCV20 plus placebo (PCV20-only group); or placebo plus placebo (placebo group). The primary outcome was Omicron-specific anti-spike protein IgG ELISA units at day 28 in the combination group compared with the NVX-only group. Non-inferiority was established if the lower limit of the two-sided 95% CI of the geometric mean titre ratio was above the non-inferiority margin of 0.67. Secondary outcomes included anti-pneumococcal capsular polysaccharide (PCP) IgG ELISA units. Solicited local and systemic adverse events were collected for 7 days after vaccination. This study was registered with ClinicalTrials.gov, number NCT05767606, and the EU Clinical Trials Register, EudraCT number 2022–004118-12.</div></div><div><h3>Results</h3><div>All 256 randomised participants completed the study. The baseline characteristics were similar in the four groups. Overall, the median age was 64 (IQR 61 to 69) and 105 (41%) of 256 were male. At day 28, the geometric mean anti-spike protein IgG ELISA units were 534 U/mL (95% CI 432–660) in the combination group and 556 U/mL (95% CI 460–672) in the NVX-only group, resulting in a geometric mean titre ratio of 0.96 (95% CI 0.73–1.27), thereby meeting the criteria for non-inferiority.</div><div>Anti-PCP IgG ELISA units at day 28 were 507 U/mL (95% CI 416–619) in the combination group and 592 U/mL (95% CI 485–723) in the PCV20-only group. Local and systemic reactogenicity was similar in the three active treatment groups. No safety concerns or serious adverse events were observed.</div></div><div><h3>Conclusions</h3><div>Immunogenicity following co-administration of NVX-CoV2601 with PCV20 was non-inferior to administration of NVX-CoV2601 alone. Given the similar safety and reactogenicity profile, our findings may help to overcome concerns about concomitant vaccination and pave the way for combination vaccines.</div></div><div><h3>Funding</h3><div>Novavax.</div></div>","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"90 2","pages":"Article 106405"},"PeriodicalIF":14.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.jinf.2024.106403
Ting Xu, Daoqun Li, Junwen Luan, Leiliang Zhang
{"title":"Dasabuvir: An FDA-approved drug inhibiting poxvirus transmission by targeting both migrasome formation and extracellular enveloped virus production","authors":"Ting Xu, Daoqun Li, Junwen Luan, Leiliang Zhang","doi":"10.1016/j.jinf.2024.106403","DOIUrl":"10.1016/j.jinf.2024.106403","url":null,"abstract":"","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"90 2","pages":"Article 106403"},"PeriodicalIF":14.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142928489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.jinf.2025.106408
Anastasia A. Theodosiou , Paul-Enguerrand Fady , Natalie Bennett, Robert C. Read, Debby Bogaert, Christine E. Jones
{"title":"Microbiotoxicity: A call to arms for cross-sector protection of the human microbiome","authors":"Anastasia A. Theodosiou , Paul-Enguerrand Fady , Natalie Bennett, Robert C. Read, Debby Bogaert, Christine E. Jones","doi":"10.1016/j.jinf.2025.106408","DOIUrl":"10.1016/j.jinf.2025.106408","url":null,"abstract":"","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"90 2","pages":"Article 106408"},"PeriodicalIF":14.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142958193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.jinf.2025.106410
Laura C. González Villeta , Linda Chanamé Pinedo , Alasdair J.C. Cook , Eelco Franz , Theo Kanellos , Lapo Mughini-Gras , Gordon Nichols , Roan Pijnacker , Joaquin M. Prada , Christophe Sarran , Matt Spick , Jessica Wu , Giovanni Lo Iacono
Objectives
This study aimed to improve the understanding of seasonal incidence pattern observed in salmonellosis by identifying the most influential weather factors, characterising the nature of this association, and assessing whether it is geographically restricted or generalisable to other locations.
Methods
A novel statistical model was employed to estimate the incidence of salmonellosis conditional to various combinations of three simultaneous weather factors from 14 available. The analysis utilised daily salmonellosis cases reported from 2000 to 2016 along with detailed spatial and temporal weather data from England and Wales, and the Netherlands.
Results
The incidence simulated from weather data effectively reproduced empirical incidence patterns in both countries. Key weather factors associated with increased salmonellosis cases, regardless of geographical location, included air temperature (>10 ⁰C), relative humidity, reduced precipitation, dewpoint temperature (7–10 ⁰C), and longer day lengths (12–15 h). Other weather factors, such as air pressure, wind speed, temperature amplitude, and sunshine duration, showed limited or no association with the empirical data. The model was suitable for the Netherlands, despite a difference in case ascertainment.
Conclusions
The conditional incidence is a simple and transparent method readily applicable to other countries and weather scenarios that provides a detailed description of salmonellosis cases conditional on local weather factors.
{"title":"Identifying key weather factors influencing human salmonellosis: A conditional incidence analysis in England, Wales, and the Netherlands","authors":"Laura C. González Villeta , Linda Chanamé Pinedo , Alasdair J.C. Cook , Eelco Franz , Theo Kanellos , Lapo Mughini-Gras , Gordon Nichols , Roan Pijnacker , Joaquin M. Prada , Christophe Sarran , Matt Spick , Jessica Wu , Giovanni Lo Iacono","doi":"10.1016/j.jinf.2025.106410","DOIUrl":"10.1016/j.jinf.2025.106410","url":null,"abstract":"<div><h3>Objectives</h3><div>This study aimed to improve the understanding of seasonal incidence pattern observed in salmonellosis by identifying the most influential weather factors, characterising the nature of this association, and assessing whether it is geographically restricted or generalisable to other locations.</div></div><div><h3>Methods</h3><div>A novel statistical model was employed to estimate the incidence of salmonellosis conditional to various combinations of three simultaneous weather factors from 14 available. The analysis utilised daily salmonellosis cases reported from 2000 to 2016 along with detailed spatial and temporal weather data from England and Wales, and the Netherlands.</div></div><div><h3>Results</h3><div>The incidence simulated from weather data effectively reproduced empirical incidence patterns in both countries. Key weather factors associated with increased salmonellosis cases, regardless of geographical location, included air temperature (>10 ⁰C), relative humidity, reduced precipitation, dewpoint temperature (7–10 ⁰C), and longer day lengths (12–15 h). Other weather factors, such as air pressure, wind speed, temperature amplitude, and sunshine duration, showed limited or no association with the empirical data. The model was suitable for the Netherlands, despite a difference in case ascertainment.</div></div><div><h3>Conclusions</h3><div>The conditional incidence is a simple and transparent method readily applicable to other countries and weather scenarios that provides a detailed description of salmonellosis cases conditional on local weather factors.</div></div>","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"90 2","pages":"Article 106410"},"PeriodicalIF":14.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143015276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.jinf.2024.106387
Zhongqiu Teng , Xue Zhang , Na Zhao, Lupeng Dai, Xianxian Zhang, Ling Han, Tian Qin
{"title":"The increasing prevalence of Japanese spotted fever in China: A dominant rickettsial threat","authors":"Zhongqiu Teng , Xue Zhang , Na Zhao, Lupeng Dai, Xianxian Zhang, Ling Han, Tian Qin","doi":"10.1016/j.jinf.2024.106387","DOIUrl":"10.1016/j.jinf.2024.106387","url":null,"abstract":"","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":"90 2","pages":"Article 106387"},"PeriodicalIF":14.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142899799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}