Emory University
Clesrovimab is an FDA-approved antibody drug recommended for infants younger than 8 months who are entering their first respiratory syncytial virus (RSV) season and whose mothers did not receive an RSV vaccine during pregnancy. It is given to help prevent severe RSV illness. This study will measure clesrovimab and other RSV antibodies in infants' blood and noses to learn how much of the drug reaches the nose, how long the antibodies remain, and how antibody levels change if an infant becomes infected with RSV.
The study will enroll 24 infants younger than 8 months who are entering their first RSV season. The study includes minors and may include newborn infants. Written permission will be obtained from a parent or legally authorized representative before any study procedures occur. Infant assent will not be obtained because the participants are too young to provide it. Each infant will receive one injection of clesrovimab as part of the usual care recommended to prevent serious RSV illness. Study staff will collect blood and nasal samples before the injection, at either Day 8 or Day 45, and at Day…
Inclusion Criteria: 1. An infant who is \<8 months of age at the time of immunization and born during or entering their first respiratory season. 2. The infant is in good health as established by medical history and investigator's discretion before entering the study. Chronic medical conditions are acceptable, provided that they are stable. 3. Written informed consent is obtained from the participant's parent(s)/legally authorized representative(s) (LAR) prior to performing any study specific procedures, including screening evaluations. 4. At least one parent/legally authorized representative…
Clesrovimab (ENFLONSIA™) is a commercially available product that is administered as part of standard-of-care RSV prevention.
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