Deidre Wilkins, Ulrika Wählby Hamrén, Yue Chang, Lindsay E Clegg, Joseph Domachowske, Janet A Englund, William J Muller, Amanda Leach, Elizabeth J Kelly, Tonya Villafana
{"title":"RSV Neutralizing Antibodies Following Nirsevimab and Palivizumab Dosing.","authors":"Deidre Wilkins, Ulrika Wählby Hamrén, Yue Chang, Lindsay E Clegg, Joseph Domachowske, Janet A Englund, William J Muller, Amanda Leach, Elizabeth J Kelly, Tonya Villafana","doi":"10.1542/peds.2024-067174","DOIUrl":null,"url":null,"abstract":"<p><p></p><p><strong>Background: </strong>Data describing respiratory syncytial virus (RSV) neutralizing antibody (nAb) levels for nirsevimab, a recently approved, extended half-life, anti-RSV fusion protein (F protein) monoclonal antibody, relative to the previous standard of care, palivizumab, have not been reported.</p><p><strong>Methods: </strong>MEDLEY was a randomized, palivizumab-controlled, phase 2/3 study of nirsevimab during 2 RSV seasons (season 1 and 2) in infants born preterm (≤35 weeks' gestational age; dosed season 1 only) or with congenital heart disease or chronic lung disease of prematurity (dosed seasons 1 and 2). Participants were randomly assigned to receive a single dose of nirsevimab followed by 4 monthly placebo doses, or 5 once-monthly doses of palivizumab. Anti-RSV F protein serology (ie, levels of prefusion [pre-F]/postfusion [post-F] conformation antibodies), nirsevimab and palivizumab concentrations, and RSV nAbs were measured in participant serum collected at baseline (pre-dose) and days 31, 151, and 361.</p><p><strong>Results: </strong>Serologic data were similar in seasons 1 and 2. Nirsevimab predominately conferred pre-F antibodies, whereas palivizumab conferred pre-F and post-F antibodies. Nirsevimab and palivizumab serum concentrations highly correlated with nAb levels in both seasons. In season 1, nAb levels in nirsevimab recipients were highest in day 31 samples and gradually declined but remained 17-fold above baseline at day 361. nAb levels in palivizumab recipients increased incrementally with monthly doses to day 151. nAb levels followed similar patterns in season 2. nAb levels were ∼10-fold higher with nirsevimab compared with palivizumab across both seasons.</p><p><strong>Conclusions: </strong>Nirsevimab prophylaxis confers ∼10-fold higher and more sustained RSV nAb levels relative to palivizumab.</p>","PeriodicalId":20028,"journal":{"name":"Pediatrics","volume":" ","pages":""},"PeriodicalIF":6.2000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatrics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1542/peds.2024-067174","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Data describing respiratory syncytial virus (RSV) neutralizing antibody (nAb) levels for nirsevimab, a recently approved, extended half-life, anti-RSV fusion protein (F protein) monoclonal antibody, relative to the previous standard of care, palivizumab, have not been reported.
Methods: MEDLEY was a randomized, palivizumab-controlled, phase 2/3 study of nirsevimab during 2 RSV seasons (season 1 and 2) in infants born preterm (≤35 weeks' gestational age; dosed season 1 only) or with congenital heart disease or chronic lung disease of prematurity (dosed seasons 1 and 2). Participants were randomly assigned to receive a single dose of nirsevimab followed by 4 monthly placebo doses, or 5 once-monthly doses of palivizumab. Anti-RSV F protein serology (ie, levels of prefusion [pre-F]/postfusion [post-F] conformation antibodies), nirsevimab and palivizumab concentrations, and RSV nAbs were measured in participant serum collected at baseline (pre-dose) and days 31, 151, and 361.
Results: Serologic data were similar in seasons 1 and 2. Nirsevimab predominately conferred pre-F antibodies, whereas palivizumab conferred pre-F and post-F antibodies. Nirsevimab and palivizumab serum concentrations highly correlated with nAb levels in both seasons. In season 1, nAb levels in nirsevimab recipients were highest in day 31 samples and gradually declined but remained 17-fold above baseline at day 361. nAb levels in palivizumab recipients increased incrementally with monthly doses to day 151. nAb levels followed similar patterns in season 2. nAb levels were ∼10-fold higher with nirsevimab compared with palivizumab across both seasons.
Conclusions: Nirsevimab prophylaxis confers ∼10-fold higher and more sustained RSV nAb levels relative to palivizumab.
期刊介绍：
The Pediatrics® journal is the official flagship journal of the American Academy of Pediatrics (AAP). It is widely cited in the field of pediatric medicine and is recognized as the leading journal in the field.
The journal publishes original research and evidence-based articles, which provide authoritative information to help readers stay up-to-date with the latest developments in pediatric medicine. The content is peer-reviewed and undergoes rigorous evaluation to ensure its quality and reliability.
Pediatrics also serves as a valuable resource for conducting new research studies and supporting education and training activities in the field of pediatrics. It aims to enhance the quality of pediatric outpatient and inpatient care by disseminating valuable knowledge and insights.
As of 2023, Pediatrics has an impressive Journal Impact Factor (IF) Score of 8.0. The IF is a measure of a journal's influence and importance in the scientific community, with higher scores indicating a greater impact. This score reflects the significance and reach of the research published in Pediatrics, further establishing its prominence in the field of pediatric medicine.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
