Lancet Microbe最新文献

筛选
英文 中文
WHO, USAID, PEPFAR: first targets of Trump's presidency
IF 20.9 1区 生物学
Lancet Microbe Pub Date : 2025-03-01 DOI: 10.1016/j.lanmic.2025.101101
Talha Burki
{"title":"WHO, USAID, PEPFAR: first targets of Trump's presidency","authors":"Talha Burki","doi":"10.1016/j.lanmic.2025.101101","DOIUrl":"10.1016/j.lanmic.2025.101101","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 3","pages":"Article 101101"},"PeriodicalIF":20.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
R21 in Matrix-M adjuvant in UK malaria-naive adult men and non-pregnant women aged 18–45 years: an open-label, partially blinded, phase 1–2a controlled human malaria infection study Matrix-M佐剂中的R21在英国18-45岁未患疟疾的成年男性和未怀孕女性中的应用:一项开放标签、部分盲法、1-2a期对照人类疟疾感染研究
IF 20.9 1区 生物学
Lancet Microbe Pub Date : 2025-03-01 DOI: 10.1016/S2666-5247(24)00083-1
Navin Venkatraman DPhil , Daniel Silman MSc , Duncan Bellamy DPhil , Lisa Stockdale PhD , Georgina Bowyer PhD , Nick J Edwards BSc , Oliver Griffiths BSc , Fernando Ramos Lopez MSc , Jonathan Powlson BSc , Catherine Mair MSc , Pedro M Folegatti MSc , Mehreen S Datoo DPhil , Richard Morter MBChB , Angela M Minassian DPhil , Ian Poulton DipHE , Katharine A Collins DPhil , Florian Brod DPhil , Philip Angell-Manning MSc , Eleanor Berrie PhD , Nathan Brendish PhD , Prof Adrian V S Hill FRS
{"title":"R21 in Matrix-M adjuvant in UK malaria-naive adult men and non-pregnant women aged 18–45 years: an open-label, partially blinded, phase 1–2a controlled human malaria infection study","authors":"Navin Venkatraman DPhil , Daniel Silman MSc , Duncan Bellamy DPhil , Lisa Stockdale PhD , Georgina Bowyer PhD , Nick J Edwards BSc , Oliver Griffiths BSc , Fernando Ramos Lopez MSc , Jonathan Powlson BSc , Catherine Mair MSc , Pedro M Folegatti MSc , Mehreen S Datoo DPhil , Richard Morter MBChB , Angela M Minassian DPhil , Ian Poulton DipHE , Katharine A Collins DPhil , Florian Brod DPhil , Philip Angell-Manning MSc , Eleanor Berrie PhD , Nathan Brendish PhD , Prof Adrian V S Hill FRS","doi":"10.1016/S2666-5247(24)00083-1","DOIUrl":"10.1016/S2666-5247(24)00083-1","url":null,"abstract":"<div><h3>Background</h3><div>R21 is a novel malaria vaccine, composed of a fusion protein of the malaria circumsporozoite protein and hepatitis B surface antigen. Following favourable safety and immunogenicity in a phase 1 study, we aimed to assess the efficacy of R21 administered with Matrix-M (R21/MM) against clinical malaria in adults from the UK who were malaria naive in a controlled human malaria infection study.</div></div><div><h3>Methods</h3><div>In this open-label, partially blinded, phase 1–2A controlled human malaria infection study undertaken in Oxford, Southampton, and London, UK, we tested five novel vaccination regimens of R21/MM. A standard three-dose regimen (groups 1 and 6) was compared with a reduced (fractional) third dose (groups 2 and 5) of R21/MM, concomitant administration with viral vectors ChAd63-MVA expressing ME-TRAP (group 3), and a two-dose R21/MM regimen (group 7). Controlled Human Malaria Infection (CHMI) was delivered by mosquito bite at Imperial College London, London, UK, 3–4 weeks after final vaccination (or 18 months after final vaccination for group 6) alongside unvaccinated controls (groups 4A and 4B). The primary outcome measures were to assess safety of the vaccines in healthy malaria-naive volunteers and the efficacy (occurrence of blood-stage malaria infection) of the different vaccine regimens compared with non-vaccinated controls after CHMI. The trial was registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT02905019</span><svg><path></path></svg></span>).</div></div><div><h3>Findings</h3><div>66 volunteers were enrolled with 59 undergoing subsequent CHMI. All vaccination schedules were well tolerated. The highest level of protection against CHMI was observed in participants receiving the standard three-dose regimen of R21/MM (group 1, nine of 11 volunteers protected) with protection maintained in three of five volunteers re-challenged by CHMI 7·5 months later. Protection against malaria was also seen in group 2, group 3, and group 5 compared with unvaccinated control participants. Total IgG antibody responses to the NANP repeat region of circumsporozoite protein peaked after the third dose of R21/MM in all volunteers and were well maintained to 90 days after challenge. Reducing the third dose did not affect protection or antibody concentrations.</div></div><div><h3>Interpretation</h3><div>Our study shows that R21/MM elicits high-level efficacy against clinical malaria in a controlled human infection model of malaria in adults who are malaria naive. These data supported the evaluation of R21/MM in field efficacy trials in the target population of young children in malaria-endemic areas.</div></div><div><h3>Funding</h3><div>EU Horizon 2020, the UK Medical Research Council, the European Commission, the UK National Institute of Health Research, the Imperial NIHR Clinical Research Facility, the Oxford NIHR Biomedical Research Centre, and the Wellcome Trust.</d","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 3","pages":"Article 100867"},"PeriodicalIF":20.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142980418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Protection by natural cholera against later episodes of cholera over 10 years of follow-up in Matlab, Bangladesh: a retrospective cohort study
IF 20.9 1区 生物学
Lancet Microbe Pub Date : 2025-03-01 DOI: 10.1016/j.lanmic.2024.100981
Masuma Hoque MPH , Deok Ryun Kim PhD , Faisal Ahmmed MSc , Md Taufiqul Islam PhD , Justin Im DPhil , Birkneh Tilahun Tadesse PhD , Sophie Kang MSc , Farhana Khanam PhD , Fahima Chowdhury PhD , Tasnuva Ahmed MPH , Md Golam Firoj MSc , Asma Binte Aziz MPH , Suman Kanungo PhD , Ashraful Islam Khan PhD , Md Alfazal Khan PhD , Jooah Lee MPH , Gideok Pak MSc , Florian Marks PhD , Jerome H Kim MD , Andrew Azman PhD , Prof John D Clemens MD
{"title":"Protection by natural cholera against later episodes of cholera over 10 years of follow-up in Matlab, Bangladesh: a retrospective cohort study","authors":"Masuma Hoque MPH ,&nbsp;Deok Ryun Kim PhD ,&nbsp;Faisal Ahmmed MSc ,&nbsp;Md Taufiqul Islam PhD ,&nbsp;Justin Im DPhil ,&nbsp;Birkneh Tilahun Tadesse PhD ,&nbsp;Sophie Kang MSc ,&nbsp;Farhana Khanam PhD ,&nbsp;Fahima Chowdhury PhD ,&nbsp;Tasnuva Ahmed MPH ,&nbsp;Md Golam Firoj MSc ,&nbsp;Asma Binte Aziz MPH ,&nbsp;Suman Kanungo PhD ,&nbsp;Ashraful Islam Khan PhD ,&nbsp;Md Alfazal Khan PhD ,&nbsp;Jooah Lee MPH ,&nbsp;Gideok Pak MSc ,&nbsp;Florian Marks PhD ,&nbsp;Jerome H Kim MD ,&nbsp;Andrew Azman PhD ,&nbsp;Prof John D Clemens MD","doi":"10.1016/j.lanmic.2024.100981","DOIUrl":"10.1016/j.lanmic.2024.100981","url":null,"abstract":"<div><h3>Background</h3><div>Patients with cholera have been shown to be protected against subsequent cholera for 3 years after their initial episode. We aimed to assess protection at 10 years of follow-up.</div></div><div><h3>Methods</h3><div>In this retrospective cohort study, cohorts of patients treated for cholera (index patients) and contemporaneously selected age-matched individuals without cholera (controls), randomly selected from the population of Matlab, Bangladesh, were assembled between 1990 and 2009 and followed for up to 10 years. Selection of participants who had no history of cholera in the 5 years before selection proceeded in secular sequence, and selection was done without replacement. Protection against subsequent treated cholera was assessed in proportional hazards models and waning of protection was assessed non-parametrically with use of smoothing of protection curves.</div></div><div><h3>Findings</h3><div>We included 3925 index patients and 23 550 matched controls. Patients with El Tor cholera (26 subsequent episodes among 3619 index patients) had a 48·6% (95% CI 23·1 to 65·7; p=0·0012) lower risk of El Tor cholera than controls, with no evidence of waning during up to 10 years of follow-up (p=0·87). Index patients aged 5 years and older with El Tor cholera (nine subsequent episodes among 2279 index patients) were at a 61·7% (23·6 to 80·8; p<em>=</em>0·0065) lower risk of El Tor cholera, whereas index patients younger than 5 years with El Tor cholera (17 subsequent episodes among 1340 index patients) had a 36·2% (–5·0 to 61·3; p=0·077) lower risk (p=0·26 for the difference by age).</div></div><div><h3>Interpretation</h3><div>Protection against El Tor cholera associated with previous El Tor cholera was moderate in magnitude and sustained over 10 years of follow-up. These findings suggest the potential for sustained, long-term protection by oral cholera vaccines in populations with endemic cholera and help inform models of cholera in endemic settings.</div></div><div><h3>Funding</h3><div>Bill &amp; Melinda Gates Foundation.</div></div>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 3","pages":"Article 100981"},"PeriodicalIF":20.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143548354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pandemic risk characterisation of zoonotic influenza A viruses using the Tool for Influenza Pandemic Risk Assessment (TIPRA) 利用流感大流行风险评估工具(TIPRA)确定人畜共患病甲型流感病毒的大流行风险特征。
IF 20.9 1区 生物学
Lancet Microbe Pub Date : 2025-03-01 DOI: 10.1016/j.lanmic.2024.100973
Reina Yamaji MD , Wenqing Zhang MD , Akiko Kamata DVM , Cornelia Adlhoch PhD , David E Swayne PhD , Dmitriy Pereyaslov MD , Dayan Wang PhD , Gabriele Neumann PhD , Gounalan Pavade PhD , Prof Ian G Barr PhD , Prof Malik Peiris PhD , Richard J Webby PhD , Prof Ron A M Fouchier PhD , Sophie Von Dobschütz PhD , Thomas Fabrizio PhD , Prof Yuelong Shu PhD , Magdi Samaan DVM
{"title":"Pandemic risk characterisation of zoonotic influenza A viruses using the Tool for Influenza Pandemic Risk Assessment (TIPRA)","authors":"Reina Yamaji MD ,&nbsp;Wenqing Zhang MD ,&nbsp;Akiko Kamata DVM ,&nbsp;Cornelia Adlhoch PhD ,&nbsp;David E Swayne PhD ,&nbsp;Dmitriy Pereyaslov MD ,&nbsp;Dayan Wang PhD ,&nbsp;Gabriele Neumann PhD ,&nbsp;Gounalan Pavade PhD ,&nbsp;Prof Ian G Barr PhD ,&nbsp;Prof Malik Peiris PhD ,&nbsp;Richard J Webby PhD ,&nbsp;Prof Ron A M Fouchier PhD ,&nbsp;Sophie Von Dobschütz PhD ,&nbsp;Thomas Fabrizio PhD ,&nbsp;Prof Yuelong Shu PhD ,&nbsp;Magdi Samaan DVM","doi":"10.1016/j.lanmic.2024.100973","DOIUrl":"10.1016/j.lanmic.2024.100973","url":null,"abstract":"<div><div>A systematic risk assessment approach is essential for evaluating the relative risk of influenza A viruses (IAVs) with pandemic potential. To achieve this, the Tool for Influenza Pandemic Risk Assessment (TIPRA) was developed under the Global Influenza Programme of WHO. Since its release in 2016 and update in 2020, TIPRA has been used to assess the pandemic risk of 11 zoonotic IAVs across ten evaluation rounds. Notably, A(H7N9), A(H9N2), and A(H5) clade 2.3.4.4 viruses were re-evaluated owing to changes in epidemiological characteristics or virus properties. A(H7N9) viruses had the highest relative risk at the time of assessment, highlighting the importance of continuous monitoring and reassessment as changes in epidemiological trends within animal and human populations can alter risk profiles. The knowledge gaps identified throughout the ten risk assessments should help to guide the efficient use of resources for future research, including surveillance. The TIPRA tool reflects the One Health approach and has proven crucial for closely monitoring virus dynamics in both human and non-human populations to enhance preparedness for potential IAV pandemics.</div></div>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 3","pages":"Article 100973"},"PeriodicalIF":20.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142477429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Enhancing microbiome-based biomarkers: challenges and opportunities 加强基于微生物组的生物标志物:挑战和机遇。
IF 20.9 1区 生物学
Lancet Microbe Pub Date : 2025-03-01 DOI: 10.1016/j.lanmic.2024.101032
Rajesh Kanna Gopal , Pitchaipillai Sankar Ganesh , Naji Naseef Pathoor , Akshaya Viswanathan
{"title":"Enhancing microbiome-based biomarkers: challenges and opportunities","authors":"Rajesh Kanna Gopal ,&nbsp;Pitchaipillai Sankar Ganesh ,&nbsp;Naji Naseef Pathoor ,&nbsp;Akshaya Viswanathan","doi":"10.1016/j.lanmic.2024.101032","DOIUrl":"10.1016/j.lanmic.2024.101032","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 3","pages":"Article 101032"},"PeriodicalIF":20.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142751915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and immunogenicity of the ChAdOx1–MVA-vectored conserved mosaic HIVconsvX candidate T-cell vaccines in HIV-CORE 005.2, an open-label, dose-escalation, first-in-human, phase 1 trial in adults living without HIV-1 in the UK chadox1 - mva载体保守嵌合hiv - consvx候选t细胞疫苗在HIV-CORE 005.2中的安全性和免疫原性,这是一项开放标签、剂量递增、首次在英国进行的针对未感染HIV-1的成人的1期临床试验。
IF 20.9 1区 生物学
Lancet Microbe Pub Date : 2025-03-01 DOI: 10.1016/j.lanmic.2024.100956
Nicola Borthwick PhD , Natalia Fernandez MSc , Peter J Hayes PhD , Edmund G-T Wee PhD , Belkis M Akis Yildirim MD , Andrea Baines BSc , Megan Baker BA , Nicholas Byard MSc , Oliver Conway BA , Molly Glaze MSc , Daniel Jenkin MRCP , Colin Larkworthy HND , Michael Luciw PGCert , Abigail Platt , Ian Poulton DipHE , Merin Thomas MSc , Jack Quaddy MSc , Marion Watson PhD , Alison Crook PhD , Paola Cicconi MD , Tomáš Hanke PhD
{"title":"Safety and immunogenicity of the ChAdOx1–MVA-vectored conserved mosaic HIVconsvX candidate T-cell vaccines in HIV-CORE 005.2, an open-label, dose-escalation, first-in-human, phase 1 trial in adults living without HIV-1 in the UK","authors":"Nicola Borthwick PhD ,&nbsp;Natalia Fernandez MSc ,&nbsp;Peter J Hayes PhD ,&nbsp;Edmund G-T Wee PhD ,&nbsp;Belkis M Akis Yildirim MD ,&nbsp;Andrea Baines BSc ,&nbsp;Megan Baker BA ,&nbsp;Nicholas Byard MSc ,&nbsp;Oliver Conway BA ,&nbsp;Molly Glaze MSc ,&nbsp;Daniel Jenkin MRCP ,&nbsp;Colin Larkworthy HND ,&nbsp;Michael Luciw PGCert ,&nbsp;Abigail Platt ,&nbsp;Ian Poulton DipHE ,&nbsp;Merin Thomas MSc ,&nbsp;Jack Quaddy MSc ,&nbsp;Marion Watson PhD ,&nbsp;Alison Crook PhD ,&nbsp;Paola Cicconi MD ,&nbsp;Tomáš Hanke PhD","doi":"10.1016/j.lanmic.2024.100956","DOIUrl":"10.1016/j.lanmic.2024.100956","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;An HIV-1 vaccine is long overdue. Although vaccine research focuses on the induction of broadly neutralising antibodies, challenging infections such as HIV-1 could require parallel induction of protective T cells. It is important to recognise that not all T cells contribute to protection equally. Previously, we developed a T-cell immunogen-based bivalent mosaic vaccine, HIVconsvX, delivered by vaccine vectors ChAdOx1 and modified vaccinia Ankara. In this study, we tested the HIVconsvX vaccine regimen for the first time in humans. Other ongoing trials will assess the contribution of the vaccine-induced killer T cells to the control of HIV-1.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;HIV-CORE 005.2 was an open-label, dose-escalation, first-in-human, phase 1 trial done at the Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Oxford, UK. Eligible participants were healthy volunteers aged 18–65 years living without HIV-1 and at a low likelihood of acquiring it. Because it was the first administration of ChAdOx1.tHIVconsv1 (C1) to humans, participants were assigned stepwise to two groups. Volunteer group 1 received a low dose of C1 on enrolment. Following a satisfactory safety review 7 days after vaccination, volunteer group 2 received a full dose of C1 boosted by vaccines MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) 4 weeks later in regimen C1-M3M4 and were followed up until day 140. Focusing on the full vaccine doses in group 2, the primary outcome was the local and systemic safety of the vaccine. The secondary outcome was the frequency and breadth of epitope recognition by vaccine-induced T cells determined by IFN-γ ELISPOT assay using peripheral blood mononuclear cells (PBMC) at peak (1 and 2 weeks after the M3M4 boost) and at the end of the study, assessed against volunteer’s pre-vaccination levels. The HIV-CORE 005.2 trial is registered at &lt;span&gt;&lt;span&gt;ClinicalTrials.gov&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; (&lt;span&gt;&lt;span&gt;NCT04586673&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;) and is closed.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Findings&lt;/h3&gt;&lt;div&gt;Between July 3, 2021, and Aug 3, 2022, 13 participants were recruited and assigned to group 1 (n=3) and group 2 (n=10). Low-dose C1 was safe and well tolerated in group 1, and all three vaccine components were well tolerated in volunteer group 2. There were no serious adverse events. Local and systemic reactogenicities were consistent with intramuscular needle administration of immunogenic substances. All volunteers responded, and their vaccine-elicited T-cell frequencies peaked at a median of 4433 (IQR 2750–5820) IFN-γ spot-forming units per 10&lt;sup&gt;6&lt;/sup&gt; PBMC and recognised a median of 9 (IQR 9-10) peptide pools out of 10, indicating that the responses were broadly specific and each vaccine recipient targeted at least nine epitopes on HIV-1. These frequencies were 7·4 times lower by day 140 (ie, 3 months later). T cells proliferated upon antigen re-exposure and displayed multi","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 3","pages":"Article 100956"},"PeriodicalIF":20.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effects of amoxicillin dosage on cure rate, gut microbiota, and antibiotic resistome in vonoprazan and amoxicillin dual therapy for Helicobacter pylori: a multicentre, open-label, non-inferiority randomised controlled trial 阿莫西林剂量对vonoprazan和阿莫西林双重治疗幽门螺杆菌治愈率、肠道微生物群和抗生素抵抗组的影响:一项多中心、开放标签、非劣效性随机对照试验
IF 20.9 1区 生物学
Lancet Microbe Pub Date : 2025-03-01 DOI: 10.1016/j.lanmic.2024.100975
Yi Hu PhD , Zhen-Yu Zhang MS , Prof Fen Wang PhD , Prof Kun Zhuang PhD , Xin Xu MS , Dong-Sheng Liu MS , Hui-Zhen Fan MS , Li Yang MS , Prof Kui Jiang PhD , Prof De-Kui Zhang PhD , Prof Long Xu PhD , Jian-Hua Tang MS , Prof Xue-Mei Liu PhD , Cong He PhD , Prof Xu Shu PhD , Prof Yong Xie PhD , Prof James Y W Lau MD , Prof Yin Zhu PhD , Prof Yi-Qi Du PhD , David Y Graham MD , Prof Nong-Hua Lu MS
{"title":"Effects of amoxicillin dosage on cure rate, gut microbiota, and antibiotic resistome in vonoprazan and amoxicillin dual therapy for Helicobacter pylori: a multicentre, open-label, non-inferiority randomised controlled trial","authors":"Yi Hu PhD ,&nbsp;Zhen-Yu Zhang MS ,&nbsp;Prof Fen Wang PhD ,&nbsp;Prof Kun Zhuang PhD ,&nbsp;Xin Xu MS ,&nbsp;Dong-Sheng Liu MS ,&nbsp;Hui-Zhen Fan MS ,&nbsp;Li Yang MS ,&nbsp;Prof Kui Jiang PhD ,&nbsp;Prof De-Kui Zhang PhD ,&nbsp;Prof Long Xu PhD ,&nbsp;Jian-Hua Tang MS ,&nbsp;Prof Xue-Mei Liu PhD ,&nbsp;Cong He PhD ,&nbsp;Prof Xu Shu PhD ,&nbsp;Prof Yong Xie PhD ,&nbsp;Prof James Y W Lau MD ,&nbsp;Prof Yin Zhu PhD ,&nbsp;Prof Yi-Qi Du PhD ,&nbsp;David Y Graham MD ,&nbsp;Prof Nong-Hua Lu MS","doi":"10.1016/j.lanmic.2024.100975","DOIUrl":"10.1016/j.lanmic.2024.100975","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Vonoprazan and amoxicillin (VA) dual therapy as a mainstream &lt;em&gt;Helicobacter pylori&lt;/em&gt; regimen has gained momentum worldwide, but the optimum dosages remain unclear. We aimed to compare the efficacy and safety of VA dual therapy with 2 g amoxicillin or 3 g amoxicillin, and to assess the short-term effects of therapy on the gut microbiota and antibiotic resistome.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;We conducted an open-label, non-inferiority randomised controlled trial at 12 centres in China. Individuals infected with &lt;em&gt;H pylori&lt;/em&gt;, aged 18–70 years, and without previous eradication therapy were recruited. Participants were randomly assigned at a 1:1 ratio (block size of six) to receive vonoprazan (20 mg twice a day) with either low-dose amoxicillin (1 g twice a day; LVA therapy) or high-dose amoxicillin (1 g three times a day; HVA therapy) for 14 days. Gastric biopsies were collected before treatment for detection of antibiotic resistance. Stool samples were collected at baseline, week 2, and week 8–10 for shotgun metagenomic sequencing. The primary outcome was the eradication rate of &lt;em&gt;H pylori&lt;/em&gt;, assessed by &lt;sup&gt;13&lt;/sup&gt;C urea breath test, in both intention-to-treat and per-protocol analyses. Secondary outcomes were adverse events, adherence, antibiotic resistance, and alterations to the gut microbiota and antibiotic resistome. The margin used to establish non-inferiority was –0·10. The trial was registered with &lt;span&gt;&lt;span&gt;ClinicalTrials.gov&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;, &lt;span&gt;&lt;span&gt;NCT05649709&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Findings&lt;/h3&gt;&lt;div&gt;Between Feb 13, 2023, and Jan 25, 2024, 504 patients (204 [40%] male and 300 [60%] female; mean age 43 years [SD 13]) were randomly assigned to LVA therapy or HVA therapy (n=252 in each group). No infections were resistant to amoxicillin. The &lt;em&gt;H pylori&lt;/em&gt; eradication rate was 85·3% (215 of 252; 95% CI 80·4 to 89·2) in the LVA group and 86·5% (218 of 252; 81·7 to 90·2) in the HVA group in the intention-to-treat analysis (p=0·70) and 88·8% (213 of 240; 84·1 to 92·2) and 92·4% (218 of 236; 88·3 to 95·1), respectively, in the per-protocol analysis (p=0·18). The efficacy of LVA was non-inferior to HVA in the intention-to-treat analysis (risk difference –1·2%, 95% CI –7·3 to 4·9, p=0·0022) and the per-protocol analysis (–3·6%, –9·0 to 1·7, p=0·0085). 31 (12%) patients in the LVA group and 43 (17%) patients in the HVA group reported adverse events. Adherence to therapy was 97% in the LVA group and 96% in the HVA group. The diversity of gut microbiota decreased after treatment but was restored to baseline at week 8–10 in both groups. The abundance of beta-lactam-related resistance genes was increased at week 2 after treatment, and was restored to pretreatment level at week 8–10 for the LVA group but not the HVA group.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Interpretation&lt;/h3&gt;&lt;div&gt;LVA dual therapy was effective and non-inferior to HVA dual therapy ","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":"6 3","pages":"Article 100975"},"PeriodicalIF":20.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873248","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Combating regional outbreaks: One Health strategy integrating reverse microbial aetiology to avert global pandemics.
IF 20.9 1区 生物学
Lancet Microbe Pub Date : 2025-02-25 DOI: 10.1016/j.lanmic.2025.101091
Xulong Lang, Jianhai Yin, Yang Sun
{"title":"Combating regional outbreaks: One Health strategy integrating reverse microbial aetiology to avert global pandemics.","authors":"Xulong Lang, Jianhai Yin, Yang Sun","doi":"10.1016/j.lanmic.2025.101091","DOIUrl":"https://doi.org/10.1016/j.lanmic.2025.101091","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":" ","pages":"101091"},"PeriodicalIF":20.9,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Unexpected increase in ompA-genotype L1 variants responsible for anorectal lymphogranuloma venereum in France.
IF 20.9 1区 生物学
Lancet Microbe Pub Date : 2025-02-25 DOI: 10.1016/j.lanmic.2025.101097
Arabella Touati, Cécile Laurier-Nadalié, Cécile Bébéar, Olivia Peuchant
{"title":"Unexpected increase in ompA-genotype L1 variants responsible for anorectal lymphogranuloma venereum in France.","authors":"Arabella Touati, Cécile Laurier-Nadalié, Cécile Bébéar, Olivia Peuchant","doi":"10.1016/j.lanmic.2025.101097","DOIUrl":"https://doi.org/10.1016/j.lanmic.2025.101097","url":null,"abstract":"","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":" ","pages":"101097"},"PeriodicalIF":20.9,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effects of clinical donor characteristics on the success of faecal microbiota transplantation for patients in Denmark with Clostridioides difficile infection: a single-centre, prospective cohort study. 临床供体特征对丹麦艰难梭菌感染患者粪便微生物群移植成功率的影响:一项单中心前瞻性队列研究。
IF 20.9 1区 生物学
Lancet Microbe Pub Date : 2025-02-24 DOI: 10.1016/j.lanmic.2024.101034
Anne Karmisholt Grosen, Susan Mikkelsen, Lotte Aas Hindhede, Sara Ellegaard Paaske, Simon Mark Dahl Baunwall, Mette Mejlby Hansen, Jens Frederik Dahlerup, Martin Steen Mortensen, Tine Rask Licht, Jens Kjærgaard Boldsen, Lise Tornvig Erikstrup, Christian Lodberg Hvas, Christian Erikstrup
{"title":"Effects of clinical donor characteristics on the success of faecal microbiota transplantation for patients in Denmark with Clostridioides difficile infection: a single-centre, prospective cohort study.","authors":"Anne Karmisholt Grosen, Susan Mikkelsen, Lotte Aas Hindhede, Sara Ellegaard Paaske, Simon Mark Dahl Baunwall, Mette Mejlby Hansen, Jens Frederik Dahlerup, Martin Steen Mortensen, Tine Rask Licht, Jens Kjærgaard Boldsen, Lise Tornvig Erikstrup, Christian Lodberg Hvas, Christian Erikstrup","doi":"10.1016/j.lanmic.2024.101034","DOIUrl":"https://doi.org/10.1016/j.lanmic.2024.101034","url":null,"abstract":"<p><strong>Background: </strong>Faecal microbiota transplantation (FMT) is an effective treatment for patients with recurrent Clostridioides difficile infection, but donor selection can influence its clinical success. We aimed to investigate the effect of clinical donor characteristics on FMT outcomes in patients with C difficile infection.</p><p><strong>Methods: </strong>In this single-centre, prospective cohort study, we included all donors who fulfilled the national criteria for faeces donation and delivered donations to the Centre for Faecal Microbiota Transplantation, Aarhus University Hospital, Denmark, between May 2, 2016, and Oct 31, 2023, and corresponding recipients treated with one-dose FMT for primary or recurrent C difficile infection. In mixed-effects models, we evaluated the effect of donor sex, age, BMI, smoking status, donation stool consistency, total donation weight, antibiotic use, Helicobacter pylori carriage, birth mode, donor-recipient sex concordance, and the alpha diversity of faeces donations on FMT outcomes in recipients. The primary outcome was the resolution of diarrhoea associated with C difficile infection in patients 8 weeks after FMT.</p><p><strong>Findings: </strong>Among 145 blood donors who also donated faeces, 115 (79·3%) were men and 30 (20·7%) were women. 90 (62·1%) provided faeces for 1351 evaluable FMTs in 952 patients with C difficile infection. 1037 (76·8%) FMTs were administered through oral capsules, 151 (11·2%) via colonoscopy, and 163 FMTs (12·1%) via nasojejunal tube. Antibiotic use 3-12 months before donation decreased the effectiveness of FMT (odds ratio 0·55 [95% CI 0·33-0·91]; p=0·019). Compared with donations with a Bristol Stool Form Scale (BSFS) score of 3, donations with a score of 4 (odds ratio 1·38 [95% CI 1·04-1·83]; p=0·024) and 5 or above (2·89 [1·33-6·26]; p=0·0072) showed improved FMT effectiveness. Donor sex, BMI, smoking status, H pylori carriage, birth mode, total donation weight, and donor-recipient sex concordance did not affect FMT outcomes.</p><p><strong>Interpretation: </strong>Expanding current donor selection criteria to avoid antibiotic use in the 12 months preceding donation and including donations with a BSFS score of 5 might improve FMT outcomes for patients with C difficile infection. Our findings call for the revision of current clinical donor screening practices, and future studies could further optimise the criteria for selecting optimal faeces donors.</p><p><strong>Funding: </strong>Innovation Fund Denmark.</p>","PeriodicalId":46633,"journal":{"name":"Lancet Microbe","volume":" ","pages":"101034"},"PeriodicalIF":20.9,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信