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Can a simple flu shot protect transplant patients?

NCT ID NCT01086904

Vaccine Sponsor: Institut National de la Santé Et de la Recherche Médicale, France 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an inactivated H1N1 flu vaccine in 122 kidney transplant recipients who were at least 6 months post-transplant and on triple immunosuppression. The goal was to see if the vaccine could safely trigger an immune response. Researchers measured antibody levels and tracked side effects over several months.

What this could mean

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

Active substance
inactivated non-adjuvanted pandemic H1N1 influenza vaccine
What this could lead to
If successful, this could show that a standard flu vaccine can safely protect kidney transplant patients, who are at higher risk from flu.
What could go wrong
This is a small, completed phase 2 trial, so results may not apply to all transplant patients. The vaccine may not trigger a strong enough immune response due to their immunosuppressant drugs.

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

122 people

The number who actually took part.

Start date

Nov 2009

Finished

May 2010

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 60 years

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: * Age \> 18 and \< 60 years old * Signed information consent * Social security coverage * Renal transplantation \> 6 months with a creatinine clearance \> 20 ml/mn * Stable renal function defined as serum creatinine variation \< 20 % for the last three months * Receiving a triple immunosuppression regimen including steroids, Calcineurine inhibitors (cyclosporine or Tacrolimus), and IMPDH inhibitors (Mycophenolate Mofetil or mycophenolic acid) * Regular follow-up For child bearing aged female: * Negative urinary HCG * Contraception during the first three months of the study Exclusion criteria: * Poor renal function defined as creatinine clairance \< 20 ml/mn * Unstable renal function defined as serum creatinine variations \> 20 % during the last 3 months * Cellular or humoral acute rejection episode during the last 3 months before inclusion * Known HIV, HBV or HCV infection * Other vaccine administered during the last 3 weeks before inclusion or scheduled in the month after the second vaccine injection * Known allergy to egg proteins or to one the vaccine compounds * Severe adverse events after prior administration of any influenza vaccine * Multiple sclerosis * Past history of Guillain Barre syndrome * Fever at inclusion * H1N1 influenza episode with positive virological tests during the last 6 months * Contact with people infected with H1N1 influenza during the week prior to inclusion * Cancer requiring radiotherapy or chemotherapy during the last 6 months * Blood transfusion during the last 3 months * Pregnancy during the last 3 months * No follow-up

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Conditions

The condition(s) this trial relates to.

swine influenza prevention target

As listed by the trial registrant

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

Immunosuppression Renal transplant recipients

Contacts and locations

Locations

  • Centre hospitalier Lyon Sud, service de néphrologie transplantation

    Pierre-Bénite, Lyon, 69495, France

  • Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique

    Lyon, 69437, France

  • Service d'urologie, GH Pitié Salpêtrière

    Paris, 75013, France

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