Renal Transplant RecipientsPhase 2TransfluvacNCT01086904
Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients
A Phase 2 study testing inactivated non adjuvanted pandemic H1N1 vaccine in people with Renal Transplant Recipients and Immunosuppression, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
Trial summary
The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Renal Transplant Recipients, Immunosuppression
- What is being tested?
- inactivated non adjuvanted pandemic H1N1 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2009to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- Regular follow-up
- For child bearing aged female:
- Negative urinary HCG
- Contraception during the first three months of the study
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique
Lyon, 69437
Service d'urologie, GH Pitié Salpêtrière
Paris, 75013
Centre hospitalier Lyon Sud, service de néphrologie transplantation
Pierre-Bénite, Lyon, 69495
About this study
Official title: Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A (H1N1) après Transplantation rénale
The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.
Read the detailed description
120 renal transplant recipients under triple immunosuppression will be immunized against influenza H1N1v.
The primary endpoint will be the humoral immunity assessed 21 days after each injection on day 0 and day 21:
- seroprotection rate, defined as the percentage of patients with an antibody title against Hemaglutinin ≥ 1/40e after immunization
- seroconversion rate, defined as the the percentage of patients with an antibody title against Hemaglutinin < 1/10e before immunization and ≥ 1/40e after or with a prevaccine title ≥1/10e increasing at least 4 fold after immunization
- seroconversion factor, defined as the ratio between pre and post vaccine geometrical means of the antibody titles.
Secondary endpoints will be:
- Seroconversion rate, seroprotection rate and seroconversion factor on day 182
- Percentage of patients with an antibody title > 1/40e on day 182 (Immune memory)
- Number and severity of clinical and biological adverse events
- Number of cases of pandemic H1N1v influenza virologically confirmed
- Study of associated parameters influencing the results of H1N1v vaccination in terms of seroprotection, seroconversion and seroconversion factor
- Assessment of the cellular immune response against H1N1v
- Assessment of the H1N1v vaccination on graft function and on humoral anti-HLA response.
- Conditions
- Renal Transplant Recipients, Immunosuppression
- Being tested
- inactivated non adjuvanted pandemic H1N1 vaccine
- Keywords
- renal transplantation, immunosuppression, inflenza A (H1N1), vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inactivated non adjuvanted pandemic H1N1 vaccineBiological
two administrations at D and D21 (15 µg HA)
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant patients | Experimental | Patients included in urology and nephrology departments for : a first deep subcutaneous or intramuscular administration of the H1N1 vaccine on day 0, followed by a second deep subcutaneous or intramuscular administration of the H1N1 vaccine on day 21. Receives: Biological: inactivated non adjuvanted pandemic H1N1 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific humoral response 21 days after each administration Seroprotection and seroconversion rates
Measured: after each vaccination and at 6 months
Secondary outcomes (1)
Seroprotection and seroconversion rates at day 182;Percentage of patients with anti-H1N1v Antibodies >1/40e at day 182; Number of undesired events and of Influenza A cases; Assessment of cellular immune response against Influenza A H1N1; Effect of vacc
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionJan 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- MCM Vaccines B.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086904
- Sponsor's protocol ID
- C09-32
- Other IDs
- 2009-016659-23, 2009
- Acronym
- Transfluvac
- Status last verified
- Jul 2010
- First submitted
- 16 Nov 2009
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Le Corre N, Thibault F, Pouteil Noble C, Meiffredy V, Daoud S, Cahen R, Charreau I, Bottigioli D, Dollinger C, Aboulker JP, Autran B, Morelon E, Barrou B. Effect of two injections of non-adjuvanted influenza A H1N1pdm2009 vaccine in renal transplant recipients: INSERM C09-32 TRANSFLUVAC trial. Vaccine. 2012 Dec 14;30(52):7522-8. doi: 10.1016/j.vaccine.2012.10.047. Epub 2012 Oct 25.
PubMed 23103195
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A (H1N1) après Transplantation rénale
- ClinicalTrials.gov ID
- NCT01086904
- Acronym / sponsor ID
- Transfluvac / C09-32
- Conditions
- Renal Transplant Recipients, Immunosuppression
- Keywords
- renal transplantation, immunosuppression, inflenza A (H1N1), vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- MCM Vaccines B.V.
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.
Detailed description
120 renal transplant recipients under triple immunosuppression will be immunized against influenza H1N1v.
The primary endpoint will be the humoral immunity assessed 21 days after each injection on day 0 and day 21:
- seroprotection rate, defined as the percentage of patients with an antibody title against Hemaglutinin ≥ 1/40e after immunization
- seroconversion rate, defined as the the percentage of patients with an antibody title against Hemaglutinin < 1/10e before immunization and ≥ 1/40e after or with a prevaccine title ≥1/10e increasing at least 4 fold after immunization
- seroconversion factor, defined as the ratio between pre and post vaccine geometrical means of the antibody titles.
Secondary endpoints will be:
- Seroconversion rate, seroprotection rate and seroconversion factor on day 182
- Percentage of patients with an antibody title > 1/40e on day 182 (Immune memory)
- Number and severity of clinical and biological adverse events
- Number of cases of pandemic H1N1v influenza virologically confirmed
- Study of associated parameters influencing the results of H1N1v vaccination in terms of seroprotection, seroconversion and seroconversion factor
- Assessment of the cellular immune response against H1N1v
- Assessment of the H1N1v vaccination on graft function and on humoral anti-HLA response.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant patients | Experimental | Biological: inactivated non adjuvanted pandemic H1N1 vaccinePatients included in urology and nephrology departments for : a first deep subcutaneous or intramuscular administration of the H1N1 vaccine on day 0, followed by a second deep subcutaneous or intramuscular administration of the H1N1 vaccine on day 21. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inactivated non adjuvanted pandemic H1N1 vaccinetwo administrations at D and D21 (15 µg HA) | Biological | Kidney transplant patients |
Primary outcome
Specific humoral response 21 days after each administration Seroprotection and seroconversion rates
Time frame: after each vaccination and at 6 months
1 secondary outcome
Seroprotection and seroconversion rates at day 182;Percentage of patients with anti-H1N1v Antibodies >1/40e at day 182; Number of undesired events and of Influenza A cases; Assessment of cellular immune response against Influenza A H1N1; Effect of vacc
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Results publication: PubMed 23103195Le Corre N, Thibault F, Pouteil Noble C, Meiffredy V, Daoud S, Cahen R, Charreau I, Bottigioli D, Dollinger C, Aboulker JP, Autran B, Morelon E, Barrou B. Effect of two injections of non-adjuvanted influenza A H1N1pdm2009 vaccine in renal transplant recipients: INSERM C09-32 TRANSFLUVAC trial. Vaccine. 2012 Dec 14;30(52):7522-8. doi: 10.1016/j.vaccine.2012.10.047. Epub 2012 Oct 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inactivated non adjuvanted pandemic H1N1 vaccine in people with Renal Transplant Recipients and Immunosuppression, run by Institut National de la Santé Et de la Recherche Médicale, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific humoral response 21 days after each administration Seroprotection and seroconversion rates (time frame: after each vaccination and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01086904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.