Vaccination; InfectionCHRONOVAXNCT06088563
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX
A study testing Vaccine injection in people with Vaccination; Infection, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Immune response to influenza vaccine in kidney transplant patients Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Vaccination; Infection
- What is being tested?
- Vaccine injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2023to 19 Jun 2024
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal transplant patient;
- Follow-up at Nice University Hospital;
- Age > 18 years;
- Indication for influenza vaccination
- Free and informed consent;
- Immunosuppressive treatment including anti-calcineurin and/or Mycophenolate Mofetil (with or without corticoids).
Who cannot join
- Known hypersensitivity to influenza vaccine or egg proteins;
- Influenza vaccination for the 2023-2024 season already performed;
- Current infection;
- Current acute medical condition;
- Treatment of rejection within the previous 3 months;
- Immunosuppressive therapy including CTLA4 agonist, mTOR inhibitor, complement inhibitor, anti-CD19;
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- Polyvalent immunoglobulin infusion within the preceding 3 months;
- Vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French);
- Subjects not affiliated to the Social Security system.
Trial locations and contacts
1 site in 1 country.
About this study
Immune response to influenza vaccine in kidney transplant patients
Read the detailed description
Seasonal influenza vaccination is recommended for kidney transplant patients, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. Nevertheless, injection of influenza vaccine induces a protective immune response in only 20% to 40% of patients. Today, there are no recommendations regarding the injection time of influenza vaccine in the general population or in immunocompromised patients. In this context, recent studies conducted in healthy subjects have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza, COVID-19. On this basis, we formulate the main hypothesis that the administration of influenza vaccine to kidney transplant patients would be more effective when carried out in the morning than in the evening.
- Conditions
- Vaccination; Infection
- Being tested
- Vaccine injection
- Keywords
- Influenza, Kidney transplant, Vaccination
- Medical subject headings
- Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine injectionOther
Also called EFLUELDA - Fluzone High-Dose Quadrivalent
Injection of the vaccine in renal transplant patients.
| Study group | Role | What they receive |
|---|---|---|
| Morning injection | Active comparator | EFLUELDA influenza vaccine injection between 07:00 am and 09:00 am. Receives: Other: Vaccine injection |
| Evening injection | Active comparator | EFLUELDA influenza vaccine injection between 07:00 pm and 09:00 pm. Receives: Other: Vaccine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection in each arm.
Seroconversion will be defined as an increase in antibody titer of at least 4-fold (≥4) over pre-vaccination titer AND an antibody titer ≥ 1:40 (seroprotection) four weeks post-vaccination, for at least one of the three vaccine antigens.
Measured: 7 months
Secondary outcomes (5)
Number of seasonal influenza virus infections in each arm.
Comparing the number of seasonal influenza virus infections in kidney transplant patients between a group of patients vaccinated in the morning and a group vaccinated in the evening.
The occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.
Measured: 8 months
Comparison the evolution of antibody titres reacting in each arm.
In kidney transplant patients, compare the evolution of antibody titres reacting with vaccine antigens 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.
The titer of antibodies reacting with vaccine antigens is measured by ELISA ;
Measured: 7 months
Evolution of the number of memory B cells in each arm.
To compare in kidney transplant patients the evolution of the number of memory B cells reacting with vaccine antigens 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.
The number of memory B cells reacting with vaccine antigens will be measured by ELISPOT ;
Measured: 7 months
Evolution of the number of CD4+ T cells in each arm.
Comparing the evolution of CD4+ T cells reacting with vaccine antigens in kidney transplant patients 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.
The number of CD4+ T cells reacting with vaccine antigens will be measured by in vitro proliferation assay;
Measured: 7 months
Evolution of the number of CD8+ T cells in each arm.
Comparing the evolution of CD8+ T cells reacting with vaccine antigens in kidney transplant patients 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening.
The number of CD8+ T cells reacting with vaccine antigens will be measured by in vitro proliferation assay;
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start26 Oct 2023
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination; InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GOSSET Clément, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088563
- Sponsor's protocol ID
- 23-PP-09
- Acronym
- CHRONOVAX
- Status last verified
- Nov 2024
- First submitted
- 6 Oct 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX
- ClinicalTrials.gov ID
- NCT06088563
- Acronym / sponsor ID
- CHRONOVAX / 23-PP-09
- Conditions
- Vaccination; Infection
- Keywords
- Influenza, Kidney transplant, Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- 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.
Immune response to influenza vaccine in kidney transplant patients
Detailed description
Seasonal influenza vaccination is recommended for kidney transplant patients, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. Nevertheless, injection of influenza vaccine induces a protective immune response in only 20% to 40% of patients. Today, there are no recommendations regarding the injection time of influenza vaccine in the general population or in immunocompromised patients. In this context, recent studies conducted in healthy subjects have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza, COVID-19. On this basis, we formulate the main hypothesis that the administration of influenza vaccine to kidney transplant patients would be more effective when carried out in the morning than in the evening.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning injection | Active comparator | Other: Vaccine injectionEFLUELDA influenza vaccine injection between 07:00 am and 09:00 am. |
| Evening injection | Active comparator | Other: Vaccine injectionEFLUELDA influenza vaccine injection between 07:00 pm and 09:00 pm. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Renal transplant patient;
- Follow-up at Nice University Hospital;
- Age > 18 years;
- Indication for influenza vaccination
- Free and informed consent;
Key exclusion criteria (9 listed)
- Known hypersensitivity to influenza vaccine or egg proteins;
- Influenza vaccination for the 2023-2024 season already performed;
- Current infection;
- Current acute medical condition;
- Treatment of rejection within the previous 3 months;
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 |
|---|---|---|
| Vaccine injectionAlso: EFLUELDA - Fluzone High-Dose QuadrivalentInjection of the vaccine in renal transplant patients. | Other | Evening injection, Morning injection |
Primary outcome
Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection in each arm.
Time frame: 7 months
Seroconversion will be defined as an increase in antibody titer of at least 4-fold (≥4) over pre-vaccination titer AND an antibody titer ≥ 1:40 (seroprotection) four weeks post-vaccination, for at least one of the three vaccine antigens.
5 secondary outcomes
Number of seasonal influenza virus infections in each arm.
Time frame: 8 months
Comparison the evolution of antibody titres reacting in each arm.
Time frame: 7 months
Evolution of the number of memory B cells in each arm.
Time frame: 7 months
Evolution of the number of CD4+ T cells in each arm.
Time frame: 7 months
Evolution of the number of CD8+ T cells in each arm.
Time frame: 7 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 15 Nov 2024.
- Individual participant dataSharing planned: No
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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.
GOSSET Clément, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccine injection in people with Vaccination; Infection, run by Centre Hospitalier Universitaire de Nice at 1 site 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 6 inclusion and 9 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 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Comparison of antibody titer (seroconversion) 4 weeks after inactivated influenza vaccine injection in each arm. (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.