Vaccination; InfectionCHRONOVAX2NCT06907667
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure
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 patients with chronic renal insufficiency. 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
- 735 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Chronic renal failure patient at stage 4 or 5 (i.e. estimated GFR < 30mL/min/1.73m2); or Dialysis patient; or renal transplant patient regardless of GFR;
- Age ≥ 18 years;
- Indication for influenza vaccination;
- Express free and informed consent.
Who cannot join
- Known hypersensitivity to influenza vaccine or egg proteins;
- Previous influenza vaccination for the current season;
- Current infection;
- Current acute illness;
- Treatments with a major impact on vaccine response:
- Treatment of rejection within the previous 3 months;
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- Renal transplantation with induction performed within the previous 6 months;
- Immunosuppressive treatment including CTLA4 agonist, complement inhibitor, anti-CD20;
- Treatments that may distort the serological response: Polyvalent immunoglobulin infusion within the preceding 3 months;
- Vulnerable persons (minors, adults under guardianship or trusteeship, persons deprived of their liberty, persons unable to speak French);
- Subjects not affiliated to Social Security.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nice - Hôpital Pasteur 2
Nice, Alpes-Maritimes, 06000
Clément GOSSET, MD, 492037918 ext. +33, gosset.c@chu-nice.fr
About this study
Official title: Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2
Immune response to influenza vaccine in patients with chronic renal insufficiency.
Read the detailed description
Seasonal influenza vaccination is recommended for patients with chronic renal insufficiency, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. However, the immune response to this vaccination is limited in this population.
There are currently no recommendations concerning the timing of influenza vaccine in the general population or in immunocompromised patients.
In this context, recent studies have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza and COVID vaccinations.
On this basis, our main hypothesis is that the administration of influenza vaccine to patients with chronic kidney failure is more effective in the morning than in the evening.
- Conditions
- Vaccination; Infection
- Being tested
- Vaccine injection
- Keywords
- Influenza, chronic renal insufficiency, Vaccination
- Medical subject headings
- Infections, Influenza, Human, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine injectionOther
Also called VAXIGRIPTETRA - quadrivalent inactivated influenza vaccine.
Injection of the vaccine in chronic renal insufficiency patients.
| Study group | Role | What they receive |
|---|---|---|
| Morning injection | Active comparator | VAXIGRIPTETRA influenza vaccine injection between 07:00 am and 11:00 am. Receives: Other: Vaccine injection |
| Evening injection | Active comparator | VAXIGRIPTETRA influenza vaccine injection between 05:00 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.
Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine 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 at 4 weeks
Comparing the number of seasonal influenza virus infections in each arm between a group of patients vaccinated in the morning and a group vaccinated in the evening at 4 weeks.
The occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.
Measured: 7 months
Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months
Comparing the number of seasonal influenza virus infections in patients with chronic renal failure between a group of patients vaccinated in the morning and a group vaccinated in the evening in the 6 months following vaccination.
The occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.
Measured: 12 months
Antibody titers reacting in each arm
In patients with chronic renal failure, 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
Number of anti-vaccine antibodies inhibiting hemmagglutination
4 weeks after influenza vaccine injection, compare hemmagglutination-inhibiting anti-vaccine antibody titer in CKD patients vaccinated in the morning and evening.
The titer of hemagglutination-inhibiting anti-vaccine antibodies will be determined by hemagglutination inhibition test
Measured: 7 months
Number of neutralizing anti-vaccine antibodies
To compare, 4 weeks after influenza vaccine injection, the titer of neutralizing antivaccine antibodies in CKD patients vaccinated in the morning and evening.
The titer of neutralizing anti-vaccine antibodies will be determined by a pseudo-neutralization test.
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 posted2 Apr 2025
- Study start3 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
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.
- 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
- 735 participants (estimated)
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
- NCT06907667
- Sponsor's protocol ID
- 23-API-01
- Acronym
- CHRONOVAX2
- Status last verified
- May 2026
- First submitted
- 26 Mar 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. 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 Patients With Chronic Renal Failure - CHRONOVAX 2
- ClinicalTrials.gov ID
- NCT06907667
- Acronym / sponsor ID
- CHRONOVAX2 / 23-API-01
- Conditions
- Vaccination; Infection
- Keywords
- Influenza, chronic renal insufficiency, Vaccination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 735 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Apr 2025 (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 patients with chronic renal insufficiency.
Detailed description
Seasonal influenza vaccination is recommended for patients with chronic renal insufficiency, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. However, the immune response to this vaccination is limited in this population.
There are currently no recommendations concerning the timing of influenza vaccine in the general population or in immunocompromised patients.
In this context, recent studies have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza and COVID vaccinations.
On this basis, our main hypothesis is that the administration of influenza vaccine to patients with chronic kidney failure is more effective 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 injectionVAXIGRIPTETRA influenza vaccine injection between 07:00 am and 11:00 am. |
| Evening injection | Active comparator | Other: Vaccine injectionVAXIGRIPTETRA influenza vaccine injection between 05:00 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 (4 listed)
- Chronic renal failure patient at stage 4 or 5 (i.e. estimated GFR < 30mL/min/1.73m2); or Dialysis patient; or renal transplant patient regardless of GFR;
- Age ≥ 18 years;
- Indication for influenza vaccination;
- Express free and informed consent.
Key exclusion criteria (11 listed)
- Known hypersensitivity to influenza vaccine or egg proteins;
- Previous influenza vaccination for the current season;
- Current infection;
- Current acute illness;
- Treatments with a major impact on vaccine response:
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: VAXIGRIPTETRA - quadrivalent inactivated influenza vaccine.Injection of the vaccine in chronic renal insufficiency patients. | Other | Evening injection, Morning injection |
Primary outcome
Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine 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 at 4 weeks
Time frame: 7 months
Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months
Time frame: 12 months
Antibody titers reacting in each arm
Time frame: 7 months
Number of anti-vaccine antibodies inhibiting hemmagglutination
Time frame: 7 months
Number of neutralizing anti-vaccine antibodies
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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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.
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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 15 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GOSSET Clément, MD (492038632 ext. +33, gosset.c@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine 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 May 2026.