{"title":"'Measurement of circulating viral antigens post-SARS-CoV-2 infection in a multicohort study' - Author's reply.","authors":"Zoe Swank, Elizabeth W Karlson, David R Walt","doi":"10.1016/j.cmi.2024.10.028","DOIUrl":"10.1016/j.cmi.2024.10.028","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567549","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}
Ryo Miyakawa, Haijun Zhang, W Abdullah Brooks, Christine Prosperi, Henry C Baggett, Daniel R Feikin, Laura L Hammitt, Stephen R C Howie, Karen L Kotloff, Orin S Levine, Shabir A Madhi, David R Murdoch, Katherine L O'Brien, J Anthony G Scott, Donald M Thea, Martin Antonio, Juliet O Awori, Charatdao Bunthi, Amanda J Driscoll, Bernard Ebruke, Nicholas S Fancourt, Melissa M Higdon, Ruth A Karron, David P Moore, Susan C Morpeth, Justin M Mulindwa, Daniel E Park, Mohammed Ziaur Rahman, Mustafizur Rahman, Rasheed A Salaudeen, Pongpun Sawatwong, Phil Seidenberg, Samba O Sow, Milagritos D Tapia, Maria Deloria Knoll
{"title":"Epidemiology of human metapneumovirus among children with severe or very severe pneumonia in high pneumonia burden settings: the Pneumonia Etiology Research for Child Health (PERCH) study experience.","authors":"Ryo Miyakawa, Haijun Zhang, W Abdullah Brooks, Christine Prosperi, Henry C Baggett, Daniel R Feikin, Laura L Hammitt, Stephen R C Howie, Karen L Kotloff, Orin S Levine, Shabir A Madhi, David R Murdoch, Katherine L O'Brien, J Anthony G Scott, Donald M Thea, Martin Antonio, Juliet O Awori, Charatdao Bunthi, Amanda J Driscoll, Bernard Ebruke, Nicholas S Fancourt, Melissa M Higdon, Ruth A Karron, David P Moore, Susan C Morpeth, Justin M Mulindwa, Daniel E Park, Mohammed Ziaur Rahman, Mustafizur Rahman, Rasheed A Salaudeen, Pongpun Sawatwong, Phil Seidenberg, Samba O Sow, Milagritos D Tapia, Maria Deloria Knoll","doi":"10.1016/j.cmi.2024.10.023","DOIUrl":"10.1016/j.cmi.2024.10.023","url":null,"abstract":"<p><strong>Objectives: </strong>After respiratory syncytial virus (RSV), human metapneumovirus (hMPV) was the second-ranked pathogen attributed to severe pneumonia in the PERCH study. We sought to characterize hMPV-positive cases in high-burden settings, which have limited data, by comparing with RSV-positive and other cases.</p><p><strong>Methods: </strong>Children aged 1-59 months hospitalized with suspected severe pneumonia and age/season-matched community controls in seven African and Asian countries had nasopharyngeal/oropharyngeal swabs tested by multiplex PCR for 32 respiratory pathogens, among other clinical and lab assessments at admission. Odds ratios adjusted for age and site (adjusted OR [aOR]) were calculated using logistic regression. Aetiologic probability was estimated using Bayesian nested partial latent class analysis. Latent class analysis identified syndromic constellations of clinical characteristics.</p><p><strong>Results: </strong>hMPV was detected more frequently among cases (267/3887, 6.9%) than controls (115/4976, 2.3%), among cases with pneumonia chest X-ray findings (8.5%) than without (5.5%), and among controls with respiratory tract illness (3.8%) than without (1.8%; all p ≤ 0.001). HMPV-positive cases were negatively associated with the detection of other viruses (aOR, 0.18), especially RSV (aOR, 0.11; all p < 0.0001), and positively associated with the detection of bacteria (aORs, 1.77; p 0.03). No single clinical syndrome distinguished hMPV-positive from other cases. Among hMPV-positive cases, 65.2% were aged <1 year and 27.5% had pneumonia danger signs; positive predictive value for hMPV aetiology was 74.5%; mortality was 3.9%, similar to RSV-positive (2.4%) and lower than that among other cases (9.6%).</p><p><strong>Discussion: </strong>HMPV-associated severe paediatric pneumonia in high-burden settings was predominantly in young infants and clinically indistinguishable from RSV. HMPV-positives had low case fatality, similar to that in RSV-positives.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567543","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}
Rodrigo Nunes Rodrigues-da-Silva, Laura Sant'anna Ataides, Rodrigo Nogueira Angerami, Marcos Vinícius da Silva, Elba Regina Sampaio de Lemos
{"title":"Questioning the existence of Baggio-Yoshinari syndrome in Brazil.","authors":"Rodrigo Nunes Rodrigues-da-Silva, Laura Sant'anna Ataides, Rodrigo Nogueira Angerami, Marcos Vinícius da Silva, Elba Regina Sampaio de Lemos","doi":"10.1016/j.cmi.2024.10.027","DOIUrl":"10.1016/j.cmi.2024.10.027","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567552","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":"Interventions targeting the nasal microbiome to eradicate MRSA.","authors":"Mary T Bessesen","doi":"10.1016/j.cmi.2024.10.022","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.022","url":null,"abstract":"<p><strong>Background: </strong>Staphylococcus aureus is an important pathogen in many sites, including bloodstream, skin and soft tissue, bone and joints. When infection is caused by methicillin resistant S. aureus (MRSA) therapy is more difficult and outcomes are less favorable. Nasal colonization is associated with increased risk for MRSA infections. The nasal microbiome may play a role in risk for nasal colonization and infection.</p><p><strong>Objectives: </strong>To review the role of the microbiome in MRSA nasal colonization and infection.</p><p><strong>Sources: </strong>Peer reviewed literature identified in a Medline search using MRSA, S. aureus, prebiotic and microbiota as search terms.</p><p><strong>Content: </strong>Reduction of S. aureus nasal colonization has been shown to reduce risk of S. aureus infections, but decolonization methods are imperfect. The role of the nasal microbiome in host defense against S. aureus colonization and infection is explored. Numerous organisms have been shown to be negatively associated with S. aureus colonization. Antimicrobial molecules produced by these organisms are an active area of research.</p><p><strong>Implications: </strong>Future research should focus on development of safe and effective molecules that can inhibit S. aureus in the nasal vestibule. Damage to the diverse nasal microbiota by unnecessary antibiotics should be avoided.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557319","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}
Elda Righi, Massimo Mirandola, Alessandra Agnese Grossi, Murat Akova, Evelina Tacconelli, Anna Fratucello, Asma Nasim, Aleksandra Barac, Dafna Yahav
{"title":"Infectious Diseases Ethics: A Worldwide Survey.","authors":"Elda Righi, Massimo Mirandola, Alessandra Agnese Grossi, Murat Akova, Evelina Tacconelli, Anna Fratucello, Asma Nasim, Aleksandra Barac, Dafna Yahav","doi":"10.1016/j.cmi.2024.10.021","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.021","url":null,"abstract":"<p><strong>Objectives: </strong>COVID-19 unravelled new ethical issues in the neglected field of infectious diseases ethics (IDE). We investigated IDE involvement among ID professionals.</p><p><strong>Methods: </strong>A global survey was disseminated during 2021-2022. Responses were stratified by demographics, WHO region, income, and ethics training. A confirmatory factor analysis (CFA) was used to identify two themes representing IDE relevant areas (Theme 1, including stigma, inequity, vulnerability, public health, and global impact) and emerging topics (Theme 2, including inequity and research integrity in COVID-19, increased ethics interest, and gaps in IDE). Quantile and logistic regression analyses investigated determinants of ethics themes and responders' ethics attitude.</p><p><strong>Results: </strong>We included 477 participants from 71 countries. Most were females (282/460, 61%) and clinicians (327/457, 72%). Participants advocated further personal (289/443, 65%) or societies' (374/450, 83%) involvement in bioethics. Only 5% (22/477) of respondents claimed to have received enough bioethics training and 28% (114/412) were dissatisfied with it. Dedicated courses or expert case discussion were the preferred ways for receiving education in bioethics. Theme 1 and 2 median values were above 7 (on a 1-10 scale), showing high interest in IDE. CFA showed optimal and acceptable fit, respectively. Being from the region of Americas was associated with Theme 1, while having received bioethics training was associated with both themes. Females, respondents trained in bioethics, and those from the Americas and Europe regions reported lower involvement in bioethics activities, while those aged between 44-54 years and trained in bioethics were more involved. Age above 55 years and non-clinical role were negatively associated with aspiration for further bioethics involvement.</p><p><strong>Conclusions: </strong>We identified IDE themes that can inform on gaps in bioethics. Ethics training was associated with interest in IDE and bioethics activities and should be offered to integrate this discipline into daily clinical practice across age, gender, and different areas worldwide.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567546","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}
Hongyu Wang, Gang Wang, Yan Gao, Lihong Qu, Hong Wang, Min Deng, Hainv Gao, Yilin Li, Nan Yang, Baogui Wang, Rongge Liu, Xuzhu Ma, Zhen Tao, Guoqiang Zhang, Qian Wang, Weifeng Zhao, Yunsong Yu, Lin Chen, Lianchun Liang, Shengyu Wang, Lei Shao, Tao Yang, JingLei Cao, Yuan Cao, Xiaoli Qin, Jingwen Ai, Huadong Zhu, Wenhong Zhang
{"title":"Efficacy and safety of ZX-7101A, an inhibitor of influenza cap-dependent endonuclease, in adults with uncomplicated influenza: a randomised, double-blind, placebo-controlled phase 2/3 Trial.","authors":"Hongyu Wang, Gang Wang, Yan Gao, Lihong Qu, Hong Wang, Min Deng, Hainv Gao, Yilin Li, Nan Yang, Baogui Wang, Rongge Liu, Xuzhu Ma, Zhen Tao, Guoqiang Zhang, Qian Wang, Weifeng Zhao, Yunsong Yu, Lin Chen, Lianchun Liang, Shengyu Wang, Lei Shao, Tao Yang, JingLei Cao, Yuan Cao, Xiaoli Qin, Jingwen Ai, Huadong Zhu, Wenhong Zhang","doi":"10.1016/j.cmi.2024.10.020","DOIUrl":"https://doi.org/10.1016/j.cmi.2024.10.020","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the efficacy and safety of ZX-7101A: an inhibitor of influenza viral cap-dependent endonuclease, in adults with uncomplicated influenza and explore treatment-emergent resistance.</p><p><strong>Methods: </strong>We conducted a randomized, double-blind, placebo-controlled, adaptive-design phase 2 and phase 3 studies (ZX-7101A-202) in adults with uncomplicated influenza. Eligible patients were randomised 1:1:1 to receive a single dose of 40 or 80mg ZX-7101A or placebo, stratified by body weight and baseline composite symptom score. The primary efficacy endpoint was time to alleviation of influenza symptoms (TTAS) in intention-to-treat infected (ITTI) population.</p><p><strong>Results: </strong>The phase 2 trial suggested a significantly shorter in TTAS for ZX-7101A compared to placebo: the median TTAS of 40 or 80mg ZX-7101A was 34.7 hours (95% confidence interval [CI], 22.8-43.4; p=0.005) and 45.8 hours (95%CI, 32.0-66.3; p=0.020), compared with 63.6 hours (95%CI, 43.9-93.4) in the placebo group. In the phase 3 trial, the TTAS of both ZX-7101A dose groups was significantly shortened relative to the placebo: the median TTAS was shortened to 48.4 hours (95%CI, 40.5-55.6) for 40mg and 39.4 hours (95%CI, 35.8-49.3) for 80mg, compared with 62.9 hours (95%CI, 56.4-69.3) for placebo (p=0.003 and p<0.001, respectively). In the safety population, ZX-7101A treatment was associated with fewer adverse events (AEs), with 41.8% (100/239) in the 40mg group, 44.2% (106/240) in the 80mg group, and 53.8% (129/240) in the placebo group. The majority of AEs were mild or moderate. Emergence of resistance to ZX-7101A through I38T amino acid substitution was detected in 5/122 (4.1%) patients.</p><p><strong>Conclusions: </strong>ZX-7101A was an effective treatment for influenza with a single dose of either 40mg or 80mg, with more rapid alleviation of influenza symptoms versus placebo. No safety concerns were identified with single-dose treatment of ZX-7101A.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567538","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":"Agreement between Mycobacterium tuberculosis antigen-based skin test and interferon-gamma release assay in elderly individuals aged ≥65 years in China.","authors":"Yijun He, Lingyu Shen, Jiang Du, Xuefang Cao, Bin Zhang, Dakuan Wang, Boxuan Feng, Zihan Li, Yuanzhi Di, Juanjuan Huang, Tonglei Guo, Jianguo Liang, Jiaoxia Yan, Zisen Liu, Qi Jin, Weitao Duan, Henan Xin, Lei Gao","doi":"10.1016/j.cmi.2024.10.016","DOIUrl":"10.1016/j.cmi.2024.10.016","url":null,"abstract":"<p><strong>Objectives: </strong>To determine the agreement of Mycobacterium tuberculosis (MTB) antigen-based skin test (TBST) with interferon-gamma release assay (IGRA) in the elderly individuals aged ≥65 years beyond instruction for use in China.</p><p><strong>Methods: </strong>Based on the baseline survey of a randomized controlled trial with the objective of exploring suitable regimens for tuberculosis(TB) preventive treatment, MTB infection was tested using TBST and IGRA in parallel in rural residents aged 50-70 years using a cross-sectional study design.</p><p><strong>Results: </strong>A total of 21 219 participants with both TBST and IGRA results were included in this analysis. The concordance between TBST and IGRA was 89.4% (95% CI, 89.0-89.8%) with a kappa coefficient of 0.61 (95% CI, 0.60-0.62). In those aged ≥65 years, the concordance was 86.5% (95% CI, 85.6-87.4%) with a kappa coefficient of 0.55 (95% CI, 0.52-0.58). 21.2% (35/165) of the participants with indeterminate IGRA results were TBST positive, and nine of them were aged ≥65 years.</p><p><strong>Discussion: </strong>The consistent agreement between TBST and IGRA in individuals aged ≥65 years suggests that TBST has the potential to be used in the elderly with age beyond instruction for use in China. The respective diagnostic performance of each test will be analysed when the longitudinal data on incident TB is obtained in the future.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":12.7,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496343","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}
Paola Cantero, Laurence Ehret-Sabatier, Cédric Lenormand, Yves Hansmann, Erik Sauleau, Laurence Zilliox, Benoit Westermann, Benoit Jaulhac, Didier Mutter, Cathy Barthel, Pauline Perdu-Alloy, Martin Martinot, Dan Lipsker, Nathalie Boulanger
{"title":"Detection of Borrelia burgdorferi sensu lato by proteomics: a complementary diagnosis tool on erythema migrans biopsies.","authors":"Paola Cantero, Laurence Ehret-Sabatier, Cédric Lenormand, Yves Hansmann, Erik Sauleau, Laurence Zilliox, Benoit Westermann, Benoit Jaulhac, Didier Mutter, Cathy Barthel, Pauline Perdu-Alloy, Martin Martinot, Dan Lipsker, Nathalie Boulanger","doi":"10.1016/j.cmi.2024.10.014","DOIUrl":"10.1016/j.cmi.2024.10.014","url":null,"abstract":"<p><strong>Objectives: </strong>We have developed targeted proteomics in the context of Lyme borreliosis (LM) as a new direct diagnostic tool for detecting Borrelia proteins in the skin of patients with erythema migrans. If satisfactory, this proteomic technique could be used in addition to culture and/or PCR for disseminated infections where Borrelia detection is essential to demonstrate active infection. In these infections, the diagnosis is indirect and relies mainly on serology.</p><p><strong>Methods: </strong>We recruited 46 patients with LM and 11 controls and collected two skin biopsies from each patient. One biopsy was used for Borrelia burgdorferi sensu lato PCR and culture and the other one was for targeted mass-spectrometry-based proteomics. Six markers of infection were selected for proteomics: Outer surface protein C (OspC), flagellin, enolase, lipoprotein gi|365823350, decorin binding protein A, and glyceraldehyde-3-phosphate dehydrogenase.</p><p><strong>Results: </strong>Culturing Borrelia from the biopsies increased the sensitivity of the methods. Among the patients included for analysis, 61% (28 patients), 61% (28), and 46% (21) were detected as positive by proteomics, PCR, and culture, respectively. PCR and proteomics were complementary. OspC and flagellin were the most frequently detected protein markers of infection by proteomics, which in some patients, detected up to nine peptides for the flagellin.</p><p><strong>Discussion: </strong>It is possible to identify bacterial makers from the skin by proteomics. Our approach can be used to diagnose tick-borne diseases such as LM.</p><p><strong>Trial registration: </strong>clinicaltrials.gov identifier: NCT02414789.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496344","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":"Re: 'Measurement of circulating viral antigens post-SARS-CoV-2 infection in a multicohort study' by Walt et al.","authors":"Guangting Zeng","doi":"10.1016/j.cmi.2024.10.018","DOIUrl":"10.1016/j.cmi.2024.10.018","url":null,"abstract":"","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496348","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}
Guillaume Favre, Rebecca L Bromley, Matthew Bluett-Duncan, Emeline Maisonneuve, Léo Pomar, Charlotte Daire, Anda-Petronela Radan, Luigi Raio, Daniel Surbek, Carolin Blume, Stylianos Kalimeris, Yoann Madec, Juliane Schneider, Myriam Bickle Graz, Ursula Winterfeld, Alice Panchaud, David Baud
{"title":"Neurodevelopmental outcomes of infants after in utero exposure to SARS-CoV-2 or mRNA-COVID-19 vaccine compared with unexposed infants: a COVI-PREG prospective cohort study.","authors":"Guillaume Favre, Rebecca L Bromley, Matthew Bluett-Duncan, Emeline Maisonneuve, Léo Pomar, Charlotte Daire, Anda-Petronela Radan, Luigi Raio, Daniel Surbek, Carolin Blume, Stylianos Kalimeris, Yoann Madec, Juliane Schneider, Myriam Bickle Graz, Ursula Winterfeld, Alice Panchaud, David Baud","doi":"10.1016/j.cmi.2024.10.019","DOIUrl":"10.1016/j.cmi.2024.10.019","url":null,"abstract":"<p><strong>Objectives: </strong>Data are lacking regarding the long-term consequences of SARS-CoV-2 and COVID-19 mRNA vaccine on infants exposed in utero. We aimed to evaluate the neurodevelopment of infants exposed prenatally to SARS-CoV-2 or mRNA-COVID-19 vaccine during pregnancy at 12 months after birth.</p><p><strong>Methods: </strong>Infants born to mothers exposed to SARS-CoV-2 or mRNA-COVID-19 vaccine during pregnancy, or unexposed to either the virus or the vaccine were enrolled from 2021 to 2023. Infants with prenatal exposure to the virus or vaccine were compared with infants without prenatal exposure to the virus and/or vaccine. Parents received a neurodevelopmental questionnaire (ages and stages questionnaire third edition) at 12 months after birth assessing five subdomains: communication, gross motor, fine motor, problem-solving, and personal social development. A low score was defined as <2 standard deviations below the normative mean in at least one of the subdomains.</p><p><strong>Results: </strong>A total of 330 infants were included (76 in the SARS-CoV-2 group, 153 in the mRNA-COVID-19 vaccine group, and 101 in the reference group). In utero exposure to the SARS-CoV-2 or mRNA-COVID-19 vaccine was not associated with an increased risk of a low score for at least one subdomain compared with the reference group. The crude ORs were 1.16 (95% CI, 0.59-2.28) and 1.04 (95% CI, 0.58-1.86), respectively. Results remained consistent in the multivariate analysis, showing no increased risk of a low score for at least one subdomain for infants exposed to the SARS-CoV-2 or mRNA-COVID-19 vaccine, compared with the reference group. The adjusted ORs were 1.74 (95% CI, 0.76-3.99) and 0.76 (95% CI, 0.39-1.49), respectively.</p><p><strong>Discussion: </strong>In utero exposure to SARS-CoV-2 or mRNA-COVID-19 vaccine was not associated with an increased risk of a low score for at least one ages and stages questionnaire third edition subdomain at 12 months after birth. Additional studies are needed to confirm our results, especially longer-term evaluation of infant development.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":12.7,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496346","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}