Can a booster RSV shot shield the immunocompromised?
NCT ID NCT07768345
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 440 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- 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.
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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Get notified about this study
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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
5 sites. 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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Kaiser Foundation Hospital LAMC
RECRUITINGLos Angeles, California, 90027, United States
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Kaiser Permanente
RECRUITINGLos Angeles, California, 90027, United States
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Kaiser Permanente Los Angeles Medical center
RECRUITINGLos Angeles, California, 90027, United States
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Rochester Clinical Research
NOT_YET_RECRUITINGRochester, New York, 14609, United States
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The Hope Clinic of Emory University
NOT_YET_RECRUITINGDecatur, Georgia, 30030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The Little-Known virus that may rival RSV and flu in older adults
- Can an inhaled drug tame RSV symptoms in adults?
- Can a new vaccine shield adults from RSV?
- One shot, two viruses? new mRNA vaccine targets RSV and hMPV
- New mRNA vaccine aims to shield against RSV
- Massive RSV vaccine study uses real-world data to see if shots prevent severe illness