The EMBRACE Study: Enflonsia Monoclonal in Babies - RSV Antibody Concentration Evaluation

ConditionRSV Infection

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

AgeUp to 8

SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

An infant who is <8 months of age at the time of immunization and born during or entering their first respiratory season.

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.

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.

At least one parent/legally authorized representative of the subject is willing and able to maintain communication with the study site for the duration of the study.

Disqualifiers

Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 3 days prior to enrollment.

Any current or expected receipt of immunosuppressive agents including systemic steroids (except for the use of topical steroids according to the judgment of the investigator).

Known immunodeficiency, including human immunodeficiency virus (HIV).

Any known allergy or hypersensitivity to immunoglobulin products.

Trial design

Design model

Single group

Treatments tested in this trial

Clesrovimab
Biological/Vaccine
Clesrovimab (ENFLONSIA™) is a commercially available product that is administered as part of standard-of-care RSV prevention.

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: Infants Receiving Clesrovimab (Enflonsia™)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Geometric mean concentration (GMC) of serum RSV pre-fusion (preF) binding IgG antibodies

RSV pre-fusion (preF) IgG binding antibodies in serum specimens will be quantified. Assay results will be reported as concentrations (arbitrary units per milliliter, AU/mL) derived from a calibrated standard curve. Serum RSV preF IgG concentrations will be summarized as geometric mean concentrations (GMC) at each study timepoint.

Time frame