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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07824167
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • RSV Infection

Eligibility Criteria

Sex
ALL
Age
N/A - 8 Months
Healthy Volunteers
Not accepted

Interventions

  • Clesrovimab — BIOLOGICAL
    Clesrovimab (ENFLONSIA™) is a commercially available product that is administered as part of standard-of-care RSV prevention.

Study Details

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.

Key Dates

First listed
Sep 17, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Infants Receiving Clesrovimab (Enflonsia™)
    Participants will receive a single injection of clesrovimab intramuscularly in the anterolateral thigh at a dose of 105 mg, at Visit 1 (Day 1).

Primary Outcome Measure

Geometric mean concentration (GMC) of serum RSV pre-fusion (preF) binding IgG antibodies [ Time Frame: Baseline (Day 1), assigned early follow-up timepoint (Day 8 or Day 45) and Day 181 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory Children's Center-Vaccine Research ClinicAtlantaGeorgia30322
Jessica McCaffery, PhD
[email protected]
404-727-4044
Christina Rostad, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory Children's Center-Vaccine Research Clinic· Atlanta, GA

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