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Could a double-dose flu vaccine protect vulnerable transplant patients better?

NCT ID NCT04613206

Vaccine Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares high-dose and standard-dose flu vaccines in 396 adults who received a kidney, heart, or liver transplant within the past year. The goal is to see if a higher dose or two doses provide better protection against the flu. Results will help improve vaccine recommendations for this vulnerable group.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 396 people

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

Started

Jan 2021

Expected to finish

Dec 2026

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

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.

Inclusion criteria 1. Adult SOT recipients who have undergone kidney, heart, and/or liver transplantation I. Multiple organ recipients are permitted (i.e. any combination of organs including kidney, heart and/or liver). II. Subjects undergoing re-transplantation are permitted 2. Age ≥18 years at vaccination 3. ≥1 month and \<12 months post-SOT 4. Anticipated to be available for duration of study 5. Can be reached by telephone, email, or text message Exclusion criteria 1. History of severe hypersensitivity to previous influenza vaccination or anaphylaxis to eggs/egg protein 2. History of Guillain-Barre syndrome 3. History of known active infection with HIV 4. History of known severe latex hypersensitivity 5. History of receiving the current season's influenza vaccine post-transplant prior to enrollment in the study 6. Pregnant female 7. Proven influenza disease after September 1st and before first study vaccine (patient can still receive the second influenza vaccination despite proven influenza disease once enrolled) 8. History of lung or intestine transplant 9. CMVIG/IVIG/SCIG receipt in the 28 days prior to or planned administration within 84-126 days of the calendar date of first vaccination 10. Subjects must have a platelet count of \<20,000 to receive the immunizations

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Conditions

The condition(s) this trial relates to.

disease related to transplantation Infections infectious disease influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immunization; infection Influenza Solid organ transplant Transplantation infection

Contacts and locations

Locations

  • Vanderbilt Univeristy Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.