Publications by authors named "J B Domachowske"
Immunogenicity, Reactogenicity, and Safety of a Pentavalent Meningococcal ABCWY Vaccine in Adolescents and Young Adults who had Previously Received a Meningococcal ACWY Vaccine: Phase 3, Randomized, Controlled Clinical Study.
Clin Infect Dis
December 2024
Background: A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the five meningococcal serogroups that cause most invasive disease cases.
Methods: In this phase 3 study (NCT04707391), healthy participants aged 15-25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive two MenABCWY doses six months apart or one MenACWY-CRM dose. Primary objectives were to demonstrate the non-inferiority of MenABCWY 1 month post-vaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above -10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety.
Article Synopsis
- The MEDLEY trial investigated the effectiveness of nirsevimab, a new monoclonal antibody for RSV, compared to the older treatment palivizumab in preterm infants and those with specific health conditions.
- Nirsevimab was given as a single dose, while palivizumab was administered as five monthly doses, with both treatments' antibody levels monitored over two RSV seasons.
- Results showed that nirsevimab produced approximately 10 times higher and more lasting neutralizing antibody levels against RSV than palivizumab.
Article Synopsis
- 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.
The United States (U.S.) Food and Drug Administration (FDA) oversees the safety and quality of drugs and vaccines that are used in the U.
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