Accès ouvert déclaré 2026 article

Clesrovimab in Infants at Increased Risk For Severe Disease During 2 RSV Seasons

Heather J. Zar, Louis J Bont, P Manzoni, Flor M. Muñoz, Octavio Ramilo, Po-Yen Chen, José Nóvoa, GUSTAVO A. ORDONEZ, Maria Tsolia, Bruce Tapiero, Mirta I Acuña-Ávila, Javier M. Castellanos, Michaël Meyer, Ichiro Morioka, Santtu Heinonen, Ziqiang Chen, Tiantian Zeng, Radha A. Railkar, Carmen Sofia Arriola, Xiaowei Zang, Christine Hildebrand, Alvino Maestri, Luis A. Castagnini, Anushua Sinha, SMART (MK-1654-007) study group, Peter; id_orcid 0000-0001-7562-7228 Richmond, P P Birch, Ian Mitchell, Jose M Novoa Pizarro, Mirta Isabel Acuna, Andrés Maturana, Monica D'Amato, Gustavo Ordonez, William Ricardo Bachiller, Maristella Ayala, Z Straňák, Hana Wiedermannová, Hanna Välimaa, Jacques Brouard, Elodie Lecorps, Mandavi Rajguru, Olivier Tandonnet, Ulrich Thome, Mario Ruediger, Martin Wetzke, Brigitte Stiller, Elpis Hatziagorou, E J Roilides, Athanasios Michos, Vassiliki Papaevangelou, Ellis Kam Lun Hon, Oi Yin Wong, Ferenc Dicso, T G Kovacs, Gyula Tálosi, Csaba Nádor, László Ablonczy, Gábor Boross, Krisztina Szegeny, Éva Károly, Ildikó Szűcs, Danilo Buonsenso, Renato Cutrera, Eugenio Baraldi, Andrea Ronchi, Susanna Esposito, Zempei Kano, Junko Yamamoto, Tetsuya Isayama, Tetsuya Fukuoka, Hiroshi Kanda, Daigo Kajikawa, Chae Hee Chieng, M K Md Daud, Seah Kc, Mia Tuang Koh, Kassim AF, Mehala Baskaran, Efraín Montano Gonzalez, Daisy Jimenez, Miguel Angel Rodriguez Weber, Selene Najera, Javier Moises Castellanos Martinez, Håvard Ove Skjerven, Ito S, Tommy Prado-Gómez, Zoe M. Rodriguez, Kee Thai Yeo, Anthonet Lombard Koen, Shaun L. Barnabas, Moherndran Archary, Buhle Nxumalo-Toba, Azeem H. Walele, Zoe Franckling-Smith, Heather Joy Zar, Susana Ares Segura, Daniel Blázquez‐Gamero, C Fortuny Guasch, Manuel Baca Cots, Josep-Lluis Arimany Montana, Ginovart Galiana G, Fernando Cabañas González, Belén Fernández Colomer, Li-Min Huang, Cheng-Hsun Chiu, Hsin Chi, Ya-Chi Hsu, Kamolwish Laoprasopwattana, Thanyawee Puthanakit, Supattra Rungmaitree, Betül Ulukol, Benhur Şirvan Çetin, Derya Alabaz, Eray Esra Önal, Fuat Emre Canpolat, Mark Johnson, Eleri Adams, Jonathan Cohen, Paul McNamara, Eva Princess Galiza, John T.F. Ho, Scott Robert Dobson, Jennifer Lynn Nayak, Odom Mh, Dinesh K. Pillai, Chi Hornik, Carlos Riveros Sabogal, JAIME E. FERGIE, Dynio Honrubia, Lisa Mcgill-Vargas, Zach Willis, PM Parikh, Claudia M. Espinosa, Austin Wei-Hong Chan, Tarak J. Patel

2Citations signalées, ce qui n’est pas une note de qualité

24Institutions déclarées

12Pays d’affiliation déclarés

Rattachement africain : Afrique du Sud, nl, us, it, tw, cl, co, gr, ca, nz, jp, fi. Niveau de preuve : code pays fourni par la source.

Le résumé fourni par la source

Importance: Clesrovimab is a long-acting monoclonal antibody approved for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season; data concerning clesrovimab from a second RSV season among children who remain at risk for severe disease are needed. Objective: To evaluate the safety and tolerability of clesrovimab (105 mg) vs palivizumab in RSV season 1 in infants at increased risk for severe RSV disease. Key secondary objectives include describing the safety of 210 mg of clesrovimab in RSV season 2 in children who remain at increased risk for severe RSV disease, clesrovimab pharmacokinetics, and the incidence of RSV-associated disease. Design, Setting, and Participants: SMART (MK-1654-007) was a randomized, partially masked, palivizumab-controlled, phase 3 clinical trial, conducted at 110 sites in 27 countries and territories between November 30, 2021, and November 20, 2025. The population constituted palivizumab-eligible infants, including those with prematurity, chronic lung disease of prematurity, or hemodynamically significant congenital heart disease. Interventions: Participants, randomized 1:1 and stratified by region and condition, received clesrovimab (105 mg) on day 1 followed by placebo on day 28 or monthly palivizumab (15 mg/kg) up to 5 doses (1 dose per month). Eligible infants received open-label clesrovimab (210 mg) before their second RSV season. Main Outcomes and Measures: The primary outcome was the observed proportions of participants experiencing adverse events (AEs) after clesrovimab or palivizumab in season 1. Results: Overall, 997 infants (500 [50.2%] male; median age, 2.6 [range, 0.0-12.0] months) received clesrovimab, 105 mg (n = 498) or palivizumab (n = 499) in season 1; 276 received clesrovimab, 210 mg open-label in season 2. In season 1, the proportions of participants experiencing AEs were comparable between treatment groups. In season 2, clesrovimab, 210 mg was well tolerated. Incidence rates of RSV-associated medically attended lower respiratory infection (MALRI) were comparable between clesrovimab and palivizumab (3.2% [95% CI, 1.8%-5.2%] and 3.4% [95% CI, 2.0%-5.6%], respectively) through day 150 in season 1; total RSV-associated MALRI incidence through day 180 after a 210-mg dose in season 2 was 7.3% (95% CI, 4.4%-11.4%). Conclusions and Relevance: In this randomized clinical trial, clesrovimab was well tolerated in infants at increased risk for severe RSV disease through 2 RSV seasons. These findings support the use of clesrovimab in children who remain at risk for severe RSV disease in their second RSV season. Trial Registration: ClinicalTrials.gov Identifier: NCT04938830.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.

Le contrôle bibliographique ouvert

DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref: Clesrovimab in Infants at Increased Risk For Severe Disease During 2 RSV Seasons
Date Crossref: 01/09/2026
Éditeur: American Medical Association (AMA)
Type: journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.

Où se fait cette recherche

South African Medical Research Council Afrique du Sud (code pays fourni par la source)
Institution
University of Cape Town Department of Paediatrics & Child Health and SA-MRC Unit on Child & Adolescent Health University of Cape Town, Afrique du Sud (code pays fourni par la source)
Université ou école supérieure
Utrecht University pays non établi dans la notice
Université ou école supérieure
University Medical Center Utrecht pays non établi dans la notice
Établissement de santé
Yale University pays non établi dans la notice
Université ou école supérieure
Torino e-district pays non établi dans la notice
Structure de recherche
Ospedale degli Infermi pays non établi dans la notice
Établissement de santé
Baylor College of Medicine pays non établi dans la notice
Université ou école supérieure
St. Jude Children's Research Hospital pays non établi dans la notice
Établissement de santé
Taichung Veterans General Hospital pays non établi dans la notice
Établissement de santé
Universidad del Desarrollo pays non établi dans la notice
Université ou école supérieure
Hospital Padre Hurtado pays non établi dans la notice
Établissement de santé

South African Medical Research Council (Afrique du Sud), Department of Paediatrics & Child Health and SA-MRC Unit on Child & Adolescent Health — University of Cape Town (University of Cape Town, Afrique du Sud) et Utrecht University, avec 9 autres affiliations. Pays d’affiliation : Afrique du Sud.

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Les sujets associés

Respiratory viral infections researchVirus-based gene therapy researchNeonatal Respiratory Health Research

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