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How long does RSV protection last in a Baby's nose?

NCT ID NCT07824167

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

Up to 8 months

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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.