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Can a booster RSV shot shield the immunocompromised?

NCT ID NCT07768345

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This phase 3 trial is investigating whether giving a repeat dose of the RSVpreF vaccine to immunocompromised adults is safe and triggers a strong immune response. Participants, aged 18 and older, will receive one shot and be monitored for about a year. The study aims to find the best time interval for revaccination—around 1, 2, or 3 years after the first dose—to help protect this vulnerable group from severe RSV infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RSVpreF vaccine (a shot to help protect against respiratory syncytial virus)
What this could lead to
If successful, this could help determine the best timing for repeat RSV vaccinations in immunocompromised adults, potentially improving their protection against severe RSV disease.
What could go wrong
This is an early-stage study in a specific group, and the immune response may vary. As with any vaccine, there is a risk of side effects, and the results may not apply to all immunocompromised individuals.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 440 people

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

Started

Aug 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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.

Key Inclusion Criteria: * Participants ≥18 years of age who are/were immunocompromised at the time of initial RSVpreF vaccination, per study protocol, and will be grouped based on prior RSV vaccination history: * Group 1 will include participants naïve to any RSV vaccine. * Group 2 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 1 year (9 to 15 months) prior to enrollment. * Group 3 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 2 years (21 to 27 months) prior to enrollment. * Group 4 will include participants who previously received 2 doses of RSVpreF in Study C3671023 Substudy B approximately 3 years (36 to 42 months) prior to enrollment. * Participants should have a life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment. Key Exclusion Criteria: * Prior history of any subtype of Guillain-Barré Syndrome (GBS) of any etiology. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any components of the study intervention(s). * Participants with a history of transplant rejection, or PTLD, or participants who have had treatment for these conditions, within 90 days prior to study enrollment or suspected chronic humoral or cellular rejection. * Receipt of B-cell depleting therapies within 180 days prior to initial study vaccination. Refer to the study contact for further eligibility details.

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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

    5 sites. 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

  • Kaiser Foundation Hospital LAMC

    RECRUITING

    Los Angeles, California, 90027, United States

  • Kaiser Permanente

    RECRUITING

    Los Angeles, California, 90027, United States

  • Kaiser Permanente Los Angeles Medical center

    RECRUITING

    Los Angeles, California, 90027, United States

  • Rochester Clinical Research

    NOT_YET_RECRUITING

    Rochester, New York, 14609, United States

  • The Hope Clinic of Emory University

    NOT_YET_RECRUITING

    Decatur, Georgia, 30030, United States

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