Trial reportThe Journal of infectious diseases2025
A Phase 1b/2a Trial of a Half-life Extended Respiratory Syncytial Virus Neutralizing Antibody, Clesrovimab, in Healthy Preterm and Full-term Infants.
Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03524118 (A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants), which is not on this map. Cited by 28 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants
Who cites it
28 citing papers in PubMed.
- Development of High-Titer Antidrug Antibodies in a Phase 1b/2a Infant Clesrovimab Trial Are Associated With RSV Exposure Beyond Day 150.The Journal of infectious diseases · 2025Trial
- Comment on Kura et al. Cost-Effectiveness Analysis of Clesrovimab for Respiratory Syncytial Virus in Infants in the United States.Vaccines · 2026Article
- Structure and function of therapeutic antibodies approved by the US FDA in 2025.Antibody therapeutics · 2026Review
- RSV Immunoprophylaxis in Infants and Children: Old Standards, New Agents and the Complexities Therein.Vaccines · 2026Review
- Cost-Effectiveness of Nirsevimab and Clesrovimab in Preventing Respiratory Syncytial Virus Lower Respiratory Tract Disease in Infants in the United States: A Modeling Study.Infectious diseases and therapy · 2026Article
- Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants.Clinical pharmacology and therapeutics · 2026Article
- Systematic Review: Efficacy, Safety Profile, and Cost-Effectiveness of Nirsevimab Versus Palivizumab for RSV Prevention in Children Under 24 Months.Children (Basel, Switzerland) · 2026Review
- mRNA-Encoded Antibodies: An Emerging Paradigm in Antiviral Protection.Biomolecules · 2026Review
- Maternal safety outcomes of respiratory syncytial vaccination during pregnancy with a large-scale database.NPJ vaccines · 2026Article
- Article
- Preclinical characterisation of the protective capacity of an anti-nucleoprotein hRSV monoclonal antibody.EBioMedicine · 2026Article
- CXCL13 and IL-33 as Immunomodulatory Adjuvants Combined with Respiratory Syncytial Virus Fusion (RSV F) Protein to Enhance Mucosal RSV Vaccination.Infection and drug resistance · 2026Review
- Insights Into monoclonal antibodies and vaccines targeting respiratory viruses.Frontiers in pediatrics · 2026Review
- Determinants of success and failure of antibody-based strategies against respiratory viruses: insights from RSV and SARS-CoV-2.Frontiers in immunology · 2026Review
- A comprehensive strategy for pandemic preparedness with neutralizing monoclonal antibodies.mAbs · 2025Article
- Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants.Human vaccines & immunotherapeutics · 2025Article
- Respiratory syncytial virus immunization in children: The old, the new and what's just around the corner.Human vaccines & immunotherapeutics · 2025Review
- Prophylactic monoclonal antibodies against respiratory syncytial virus in early life: An in-depth review of mechanisms of action, failure factors, and future perspectives.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2025Review
- [Expert consensus on monoclonal antibody immunoprophylaxis against respiratory syncytial virus in infants and young children in tropical and subtropical regions of China].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2025Article
- Clesrovimab: First Approval.Drugs · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
Abstract
backgroundClesrovimab is an investigational monoclonal antibody with an extended half-life targeting site IV of the respiratory syncytial virus (RSV) fusion protein for the prevention of RSV disease in infants.
methodsIn this phase 1b/2a, double-blind study, 183 healthy preterm and full-term infants 2 weeks to 8 months of age were randomized 4:1 within 5 panels (preterm 20, 50, 75, or 100 mg; full-term 100 mg) to receive 1 dose of clesrovimab or placebo. The objectives were to evaluate safety, pharmacokinetics, serum neutralizing antibodies (SNA), and antidrug antibodies (ADA). The incidence of RSV-associated end points (medically attended lower respiratory tract infection, hospitalization, and acute respiratory infection) were also evaluated through 150 days postdose.
resultsThe most common adverse event through day 14 was irritability; no treatment-related serious AEs were reported. Clesrovimab serum concentrations displayed a geometric mean apparent half-life of 44.9 days. Of participants receiving clesrovimab, 51 (36.7%) developed ADA with no apparent impact in pharmacokinetics. SNA titers increased in a dose-dependent manner at day 150. The incidences of RSV-associated end points were lower in infants treated with clesrovimab compared with placebo.
conclusionsClesrovimab was generally well tolerated and exhibited an extended half-life compared to typical IgG1 antibodies, supporting its ongoing development in late-stage trials. Clinical Trial Registration. NCT03524118.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.