Coronary Artery DiseasePhase 4IVAMINCT06508437
Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease
A Phase 4 study testing Influenza Vaccination in people with Coronary Artery Disease and Inflammatory Response, run by University Hospital, Tours at 1 site in France.
Trial summary
Observational and randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. Beyond classical view of indirect effect, linked to the neutralisation of the virus, it is currently considered whether the vaccination may have a direct effect on… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Coronary Artery Disease, Inflammatory Response, Atherosclerosis
- What is being tested?
- Influenza Vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2024to 25 Nov 2024
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged ≥ 60 years.
- With documented stable coronary artery disease.
- Subjects who, in the opinion of the investigator, can comply with the protocol requirements (i.e., show up for the follow-up visit and be able to converse with study staff).
- Signature of free, written and informed consent by the patient.
- Affiliation to a French social security system.
Who cannot join
- History of serious reaction to influenza vaccine or refusal of vaccination or contraindication to vaccination.
- Participant has received the influenza vaccine within <6 months or another vaccine.
- Acute infection within <3 months or acute worsening of chronic diseases.
- Severe neurocognitive disorders (inability to give informed consent).
- Pre-existing medical conditions or medications involving the immune system (rheumatoid arthritis or other inflammatory conditions or active cancer, recent use (within the past year) of immunosuppressive or modulating agents, including oral steroids, chemotherapy, or radiation therapy) .
- Cardiovascular surgery or other interventions within 6 months preceding the study or planned during the follow-up period.
- Patient's wish or clinical situation requiring co-administration with other vaccines or any factor hindering monitoring.
- Patient under guardianship, curatorship or safeguard of justice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease - Randomized Delayed-Start Pilot Trial
Observational and randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. Beyond classical view of indirect effect, linked to the neutralisation of the virus, it is currently considered whether the vaccination may have a direct effect on inflammatory process.Atherosclerosis is known to be driven both by lipid stress and inflammation both at local and systemic level. The investigators suggest that influenza vaccination could have a positive effect on atherosclerosis by regulating plasma inflammation. The aim of this pilot study is therefore to assess the impact of influenza vaccination in patients with stable coronary artery disease on the circulating inflammatory response, in order to validate its potential immunomodulatory effect. If it is found to be beneficial, it could also constitute a future adjuvant therapeutic tool to traditional pharmacotherapy in the prevention of cardiovascular events.
Read the detailed description
A multi-center, open-label, randomized delayed-start pilot study in 2 parallel groups will be conducted: participants will be randomized as to when the influenza vaccine will be administered, according to a 1:1 ratio between influenza vaccination immediately after inclusion or at 1-month follow-up. Blood tests for plasmatic inflammation analyses will be collected at baseline and at 1 month after study inclusion.
- Being tested
- Influenza Vaccination
- Keywords
- influenza vaccination, inflammation, atherosclerosis,, coronary disease
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Influenza, Human, Inflammation, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccinationBiological
Standard Dose QIV (15µg Hemagglutinin) - VaxigripTetra Suspension for injection, 0,5ml prefilled syringe
| Study group | Role | What they receive |
|---|---|---|
| "Immediate" Vaccination Group | Active comparator | At the inclusion visit (D0), a dose of influenza vaccine will be administered. Receives: Biological: Influenza Vaccination |
| "Follow-up" vaccination group | No intervention | At the inclusion visit (D0), no immediate influenza vaccination (which will be administered one month later at the follow-up visit). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of high-sensitivity C-reactive protein (hsCRP)
Change from baseline in peripheral blood hsCRP concentrations (mg/L) between study group
Measured: Between baseline and 1-month follow up
Secondary outcomes (7)
Other Plasma inflammatory markers : Tumor necrosis factor alpha (TNF-α), Interleukin 1 beta (IL-1β), Interleukin-6 (IL-6 )
Change from baseline in peripheral blood markers: Tumor necrosis factor alpha (TNF-α), Interleukin 1 beta (IL-1β), Interleukin-6 (IL-6 ) concentrations (pg/mL) parbetween study group
Measured: Between baseline and 1-month follow up
Other Plasma inflammatory markers : N-terminal pro-B-type natriuretic peptide
Change from baseline in peripheral blood markers N-terminal pro-B-type natriuretic peptide concentrations (ng/L) between study group
Measured: Between baseline and 1-month follow up
Other Plasma inflammatory markers : fibrinogen
Change from baseline in peripheral blood markers: fibrinogen concentrations (g/L) between study group
Measured: Between baseline and 1-month follow up
Plasma arterial vulnerability markers
Change from baseline in peripheral blood markers (g/l) : Apolipoprotein B, lipoprotein(a) and low density lipoproteins cholesterol (LDLc) between study group
Measured: Between baseline and 1-month follow up
Immunoinflammatory markers in circulating immune cells : T cell response
Differences in the expression level of peripheral blood immune cells by reverse transcription and real-time PCR (RT-qPCR) of genes involved in the T-cell response (CD3, CD4, CD8) between study group.
Measured: Between baseline and 1-month follow up
Immunoinflammatory markers in circulating immune cells : T cell population
Differences in the expression level of peripheral blood immune cells by reverse transcription and real-time PCR (RT-qPCR) of genes involved in the T-cell orientation : Th1 (Tbet), Th2 (GATA3), Th17 (RORγ), Treg (FOXP3) between study group.
Measured: Between baseline and 1-month follow up
Circulating immune cells profile : percentage of peripheral immune cells
Differences in peripheral blood immune cells determined by flow cytometry from blood mononuclear cells (PBMC): Percentage of B lymphocytes (CD45+CD19+), T lymphocytes (CD45+CD3+) and monocytes (CD45+CD14+CD11c+) between study group.
Measured: Between baseline and 1-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start21 Oct 2024
- Primary completion31 Oct 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508437
- Sponsor's protocol ID
- DR240124
- Acronym
- IVAMI
- Status last verified
- Nov 2025
- First submitted
- 12 Jul 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease - Randomized Delayed-Start Pilot Trial
- ClinicalTrials.gov ID
- NCT06508437
- Acronym / sponsor ID
- IVAMI / DR240124
- Keywords
- influenza vaccination, inflammation, atherosclerosis,, coronary disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 18 Jul 2024 (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.
Observational and randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. Beyond classical view of indirect effect, linked to the neutralisation of the virus, it is currently considered whether the vaccination may have a direct effect on inflammatory process.Atherosclerosis is known to be driven both by lipid stress and inflammation both at local and systemic level. The investigators suggest that influenza vaccination could have a positive effect on atherosclerosis by regulating plasma inflammation. The aim of this pilot study is therefore to assess the impact of influenza vaccination in patients with stable coronary artery disease on the circulating inflammatory response, in order to validate its potential immunomodulatory effect. If it is found to be beneficial, it could also constitute a future adjuvant therapeutic tool to traditional pharmacotherapy in the prevention of cardiovascular events.
Detailed description
A multi-center, open-label, randomized delayed-start pilot study in 2 parallel groups will be conducted: participants will be randomized as to when the influenza vaccine will be administered, according to a 1:1 ratio between influenza vaccination immediately after inclusion or at 1-month follow-up. Blood tests for plasmatic inflammation analyses will be collected at baseline and at 1 month after study inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| "Immediate" Vaccination Group | Active comparator | Biological: Influenza VaccinationAt the inclusion visit (D0), a dose of influenza vaccine will be administered. |
| "Follow-up" vaccination group | No intervention | –At the inclusion visit (D0), no immediate influenza vaccination (which will be administered one month later at the follow-up visit). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects aged ≥ 60 years.
- With documented stable coronary artery disease.
- Subjects who, in the opinion of the investigator, can comply with the protocol requirements (i.e., show up for the follow-up visit and be able to converse with study staff).
- Signature of free, written and informed consent by the patient.
- Affiliation to a French social security system.
Key exclusion criteria (8 listed)
- History of serious reaction to influenza vaccine or refusal of vaccination or contraindication to vaccination.
- Participant has received the influenza vaccine within <6 months or another vaccine.
- Acute infection within <3 months or acute worsening of chronic diseases.
- Severe neurocognitive disorders (inability to give informed consent).
- Pre-existing medical conditions or medications involving the immune system (rheumatoid arthritis or other inflammatory conditions or active cancer, recent use (within the past year) of immunosuppressive or modulating agents, including oral steroids, chemotherapy, or radiation therapy) .
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 |
|---|---|---|
| Influenza VaccinationStandard Dose QIV (15µg Hemagglutinin) - VaxigripTetra Suspension for injection, 0,5ml prefilled syringe | Biological | "Immediate" Vaccination Group |
Primary outcome
Plasma concentration of high-sensitivity C-reactive protein (hsCRP)
Time frame: Between baseline and 1-month follow up
Change from baseline in peripheral blood hsCRP concentrations (mg/L) between study group
7 secondary outcomes
Other Plasma inflammatory markers : Tumor necrosis factor alpha (TNF-α), Interleukin 1 beta (IL-1β), Interleukin-6 (IL-6 )
Time frame: Between baseline and 1-month follow up
Other Plasma inflammatory markers : N-terminal pro-B-type natriuretic peptide
Time frame: Between baseline and 1-month follow up
Other Plasma inflammatory markers : fibrinogen
Time frame: Between baseline and 1-month follow up
Plasma arterial vulnerability markers
Time frame: Between baseline and 1-month follow up
Immunoinflammatory markers in circulating immune cells : T cell response
Time frame: Between baseline and 1-month follow up
Immunoinflammatory markers in circulating immune cells : T cell population
Time frame: Between baseline and 1-month follow up
Circulating immune cells profile : percentage of peripheral immune cells
Time frame: Between baseline and 1-month follow up
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 21 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza Vaccination in people with Coronary Artery Disease and Inflammatory Response, run by University Hospital, Tours 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 5 inclusion and 8 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 21 Nov 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Plasma concentration of high-sensitivity C-reactive protein (hsCRP) (time frame: Between baseline and 1-month follow up). 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 21 Nov 2025.