How long does RSV protection last in a Baby's nose?
NCT ID NCT07824167
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Clesrovimab is an FDA-approved antibody shot for infants under 8 months entering their first RSV season when their mothers did not get an RSV vaccine in pregnancy. Researchers at Emory University are measuring antibody levels in the blood and noses of 24 healthy infants who receive the shot as standard care. The study checks how much drug reaches the nose, how long antibodies stay, and how levels shift if a baby catches RSV.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- clesrovimab, an FDA-approved antibody drug given to infants to help prevent severe RSV illness
- What this could lead to
- If researchers learn how much clesrovimab reaches the nose and how long antibodies last, doctors could time the shot better and predict which babies stay protected through RSV season.
- What could go wrong
- The study follows only 24 infants at one site, so its antibody patterns may not reflect all babies. It measures antibody levels, not whether infants actually avoid RSV hospital visits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 8 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 of the subject is willing and able to maintain communication with the study site for the duration of the study. 5. Subject's parent(s)/legally authorized representative(s) is able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator. 6. Subject is available to complete the follow-up period, which will be approximately 6 months after receipt of the dose of study drug. Exclusion Criteria: 1. Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or acute illness within 3 days prior to enrollment. 2. 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). 3. Known immunodeficiency, including human immunodeficiency virus (HIV). 4. Any known allergy or hypersensitivity to immunoglobulin products. 5. Hypersensitivity, anaphylaxis, or seizures within 72 hours after any previous administration of a vaccine. 6. Receipt of polyclonal antibodies and/or plasma at any time prior to or planned during the study follow-up period. 7. Receipt of palivizumab, nirsevimab, or other RSV monoclonal antibody or any RSV vaccine at any time prior to or planned during the study. 8. Maternal receipt of an RSV vaccine during her pregnancy with the infant participant. 9. Use of any investigational product or non-registered product (drug or vaccine) other than the study product during the period starting 30 days before study product administration, or planned use during the study period. 10. Concurrent enrollment in another interventional study. 11. Any other condition that, in the judgment of the investigator, would be a risk to subject's safety and/or may interfere with study procedures or interpretation of results. 12. Unable to obtain baseline blood (minimum 0.5 mL) or nasal sample.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory Children's Center-Vaccine Research Clinic
Atlanta, Georgia, 30322, United States
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Other studies related to the condition(s) this trial covers.
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- Could a simple pill tame RSV? new trial tests obeldesivir
- New swab test aims to spot COVID, flu, and RSV in minutes
- New device aims to detect flu, RSV, and COVID-19 in one quick test
- RSV drug trial for kids under 5 halted early – only 4 children enrolled