Publications by authors named "V N Mankad"
Lower respiratory tract infections following respiratory syncytial virus monoclonal antibody nirsevimab immunization versus placebo: Analysis from a Phase 3 randomized clinical trial (MELODY).
Doug Arbetter Vancheswaran Gopalakrishnan Anastasia A Aksyuk Bahar Ahani Yue Chang Vaishali S Mankad
Clin Infect Dis
December 2024
Background: Nirsevimab is an extended half-life, highly potent neutralizing monoclonal antibody against the respiratory syncytial virus (RSV) fusion protein, with efficacy in preventing RSV-associated medically attended (MA) lower respiratory tract infection (LRTI) in infants and medically vulnerable children (aged ≤24 months). This post-hoc exploratory analysis examined the incidence of LRTI from RSV and other respiratory pathogens during a 2:1 randomized, double-blind, placebo-controlled, phase 3 study of nirsevimab, in healthy-term and late-preterm (i.e.
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- The MUSIC trial tested nirsevimab, a monoclonal antibody designed to treat severe RSV infections in immunocompromised children under 24 months, assessing its safety and how the body processes the drug over time.
- Out of the 100 participants with various immunocompromising conditions, most experienced minimal side effects, with three deaths occurring that were unrelated to the treatment.
- Findings showed that nirsevimab was generally well tolerated, with serum levels indicating potential effectiveness in preventing RSV infections similar to those in healthy infants, though some children had increased drug clearance that may affect efficacy.
Article Synopsis
- Nirsevimab is a long-lasting monoclonal antibody designed to prevent RSV-related respiratory issues in vulnerable infants and children, and its effectiveness was tested against the standard treatment, palivizumab, in a clinical trial called MEDLEY.
- The trial included two RSV seasons where participants received either nirsevimab or palivizumab, with ongoing assessments of RSV infections and antibody responses through nasal swabs.
- The results showed that while certain substitutions in RSV isolates developed resistance to palivizumab, no changes were found that affected nirsevimab's ability to neutralize RSV, indicating its potential superiority in preventing RSV infections.
Article Synopsis
- Nirsevimab is approved in the US for preventing RSV in neonates and infants, particularly during their first RSV season, based on safety data from three clinical trials involving different populations.
- In the studies, participants were given a single dose of nirsevimab or a comparator treatment, with safety data showing that most adverse events (AEs) were mild to moderate and largely unrelated to the treatment.
- The conclusion indicated that nirsevimab has a favorable safety profile for preventing RSV disease, regardless of the infants' gestational age or pre-existing conditions.