ImmunosenescenceREFIPANCT07239830
Interferon Reference for Older People - REFIPA Study
A study testing Uninfected older adults in people with Immunosenescence and Uninfected Older, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The diagnosis of respiratory viral infections is mainly based on PCR tests targeting the DNA or RNA of suspected viruses, including SARS-CoV-2, RSV and influenza viruses. However, this method is limited because it only tests for a small number of viruses, while many other pathogens can cause similar symptoms. Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunosenescence, Uninfected Older
- What is being tested?
- Uninfected older adults
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2025to 3 Dec 2026
- 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 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subject aged 80 or over
- Patient admitted to the Charpennes hospital day unit or outpatient clinic for follow-up OR accompanying patient who receive care at the Charpennes geriatric hospital OR subject recruited through the local press
- Weight greater than or equal to 45 kg
- Subject living in the Lyon metropolitan area
Who cannot join
- Subjects with symptoms of active infection (symptom questionnaire or temperature > 37.5°C).
- Subjects with an autoimmune disease linked to a dysregulated interferon response.
- Subjects participating in another interventional study involving an exclusion period that is still ongoing or that may interfere with the present protocol.
- Subjects deprived of their liberty by judicial or administrative decision
- Subjects receiving psychiatric care
- Adults subject to legal protection measures (guardianship, curatorship)
- Subjects not affiliated with a social security scheme or beneficiaries of a similar scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sophie TROUILLET-ASSANT contact
France1 site, 1 recruiting
- Recruiting
Hôpital des Charpennes (Hospices Civils de Lyon)
Villeurbanne, 69100
About this study
Official title: Reference Values Determination of Nasal and Blood Interferon Scores in Uninfected Older Subjects REFérence Interféron Older Subjects (Older People Interferon Reference) - REFIPA Study
The diagnosis of respiratory viral infections is mainly based on PCR tests targeting the DNA or RNA of suspected viruses, including SARS-CoV-2, RSV and influenza viruses. However, this method is limited because it only tests for a small number of viruses, while many other pathogens can cause similar symptoms. As a result, respiratory viral infections are often underdiagnosed because not all possible viruses are systematically tested for.
Another limitation of PCR tests is that they can detect residual viral genetic material long after the infection has ended, making it difficult to distinguish between an active infection and a past one. Viral load can help interpret the result, but it is not always reliable. It is therefore essential to have complementary markers that can indicate whether the detected virus is still in the active replication phase.
Read more
An innovative approach is to measure the host's immune response, in particular the production of type I interferons (IFN-I), which are markers of active viral infection. Studies have shown that joint analysis of the IFN-I/III response and PCR tests improves the detection of viral respiratory infections by better discriminating between active infections. This method shows promise for refining diagnosis, particularly in cases where the viral load is low or ambiguous.
These advances are particularly important for older patients, in whom viral infections have a severe impact. Ageing leads to a decline in immune function (immunosenescence), including a reduction in IFN-I production. This alteration could further complicate the interpretation of immune biomarkers in older people, highlighting the need to establish reference values specific to this population.
In this context, the RESPIGERIA study (compliance with MR004 No. 24-5127) was launched to evaluate the IFN response in geriatric hospitalised patients with respiratory viral infections. However, there is still a lack of reference data on the IFN response in uninfected older individuals. Establishing a baseline IFN score in this population is essential in order to adapt diagnostic tools to age-related specificities.
- Conditions
- Immunosenescence, Uninfected Older
- Being tested
- Uninfected older adults
- Keywords
- respiratory viral infection, Type I Interferon response, Older People, host-based response diagnostic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uninfected older adultsOther
The procedures specifically carried out for the study during a single visit are as follows:
- 1 nasopharyngeal swab for baseline measurement of nasal IFN score and testing for infection
- Venous blood sampling on:
- 1 x 2 mL Paxgene tube for baseline measurement of blood IFN score
- 3 x 10 mL EDTA tubes for collection of PBMCs and plasma to quantify anti-IFN antibody levels and lymphocyte subtype concentrations.
A total of 32 mL of venous blood will be collected for the study during a single visit.
A biological collection will be created with the participant's specific consent, using leftover blood and nasopharyngeal swabs after testing.
| Study group | Role | What they receive |
|---|---|---|
| Uninfected older adults | Other | Uninfected adult subjects aged 80 years and older Receives: Other: Uninfected older adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal IFN-I scores measurement in a non-infected geriatric population.
IFN-I score will be measured by assessing the expression of a selection of IFN-I-stimulated genes.
Measured: The primary outcome will be measured at inclusion visit only
Blodd IFN-I scores measurement in a non-infected geriatric population.
IFN-I score will be measured by assessing the expression of a selection of IFN-I-stimulated genes.
Measured: The primary outcome will be measured at inclusion visit only
Secondary outcomes (3)
Correlation between clinical parameters assessed by the Charlson score (comorbidities) and the Fried phenotype (frailty), and the basal blood and nasal interferon score
We hypothesize that frailty (assessed by Frailty phenotype) and comorbidities (assessed by Charlson comorbidity index) could be associated with immunosenescence and IFN-I score.
Measured: The secondary outcome will be measured at inclusion visit only
Correlation between immune parameters assessed by anti-IFN antibody concentration, concentration of lymphocyte subtypes expressing or not expressing exhaustion markers (Tim-3, PD-1, etc.) and basal blood and nasal interferon score.
Spearman correlation will be done between IFN-I score and each immune parameters.
Measured: The secondary outcome will be measured at inclusion visit only
Measurement of nasal IFN-I scores in a population of uninfected vs. infected older individuals (RESPIGERIA study, compliance with MR004 No. 24-5127).
Comparison of the score IFN-I, measured by assessing the expression of a selection of IFN-I-stimulated genes, between the two groups of interest (uninfected vs. infected older individuals).
Measured: The secondary outcome will be measured at inclusion visit only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start2 Dec 2025
- Primary completion3 Dec 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosenescenceStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-comparative and monocentric study, corresponding to researches involving human subjects (RIPH) category 2.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239830
- Sponsor's protocol ID
- 69HCL25_0689
- Acronym
- REFIPA
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2025
- Last updated
- 8 Apr 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values Determination of Nasal and Blood Interferon Scores in Uninfected Older Subjects REFérence Interféron Older Subjects (Older People Interferon Reference) - REFIPA Study
- ClinicalTrials.gov ID
- NCT07239830
- Acronym / sponsor ID
- REFIPA / 69HCL25_0689
- Conditions
- Immunosenescence, Uninfected Older
- Keywords
- respiratory viral infection, Type I Interferon response, Older People, host-based response diagnostic test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 20 Nov 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.
The diagnosis of respiratory viral infections is mainly based on PCR tests targeting the DNA or RNA of suspected viruses, including SARS-CoV-2, RSV and influenza viruses. However, this method is limited because it only tests for a small number of viruses, while many other pathogens can cause similar symptoms. As a result, respiratory viral infections are often underdiagnosed because not all possible viruses are systematically tested for.
Another limitation of PCR tests is that they can detect residual viral genetic material long after the infection has ended, making it difficult to distinguish between an active infection and a past one. Viral load can help interpret the result, but it is not always reliable. It is therefore essential to have complementary markers that can indicate whether the detected virus is still in the active replication phase.
An innovative approach is to measure the host's immune response, in particular the production of type I interferons (IFN-I), which are markers of active viral infection. Studies have shown that joint analysis of the IFN-I/III response and PCR tests improves the detection of viral respiratory infections by better discriminating between active infections. This method shows promise for refining diagnosis, particularly in cases where the viral load is low or ambiguous.
These advances are particularly important for older patients, in whom viral infections have a severe impact. Ageing leads to a decline in immune function (immunosenescence), including a reduction in IFN-I production. This alteration could further complicate the interpretation of immune biomarkers in older people, highlighting the need to establish reference values specific to this population.
In this context, the RESPIGERIA study (compliance with MR004 No. 24-5127) was launched to evaluate the IFN response in geriatric hospitalised patients with respiratory viral infections. However, there is still a lack of reference data on the IFN response in uninfected older individuals. Establishing a baseline IFN score in this population is essential in order to adapt diagnostic tools to age-related specificities.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-comparative and monocentric study, corresponding to researches involving human subjects (RIPH) category 2.
| Arm | Type | Receives |
|---|---|---|
| Uninfected older adults | Other | Other: Uninfected older adultsUninfected adult subjects aged 80 years and older |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Subject aged 80 or over
- Patient admitted to the Charpennes hospital day unit or outpatient clinic for follow-up OR accompanying patient who receive care at the Charpennes geriatric hospital OR subject recruited through the local press
- Weight greater than or equal to 45 kg
- Subject living in the Lyon metropolitan area
Key exclusion criteria (7 listed)
- Subjects with symptoms of active infection (symptom questionnaire or temperature > 37.5°C).
- Subjects with an autoimmune disease linked to a dysregulated interferon response.
- Subjects participating in another interventional study involving an exclusion period that is still ongoing or that may interfere with the present protocol.
- Subjects deprived of their liberty by judicial or administrative decision
- Subjects receiving psychiatric care
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 |
|---|---|---|
| Uninfected older adultsThe procedures specifically carried out for the study during a single visit are as follows: * 1 nasopharyngeal swab for baseline measurement of nasal IFN score and testing for infection * Venous blood sampling on: * 1 x 2 mL Paxgene tube for baseline measurement of blood IFN score * 3 x 10 mL EDTA tubes for collection of PBMCs and plasma to quantify anti-IFN antibody levels and lymphocyte subtype concentrations. A total of 32 mL of venous blood will be collected for the study during a single visit. A biological collection will be created with the participant's specific consent, using leftover blood and nasopharyngeal swabs after testing. | Other | Uninfected older adults |
Primary outcome
Nasal IFN-I scores measurement in a non-infected geriatric population.
Time frame: The primary outcome will be measured at inclusion visit only
IFN-I score will be measured by assessing the expression of a selection of IFN-I-stimulated genes.
Blodd IFN-I scores measurement in a non-infected geriatric population.
Time frame: The primary outcome will be measured at inclusion visit only
IFN-I score will be measured by assessing the expression of a selection of IFN-I-stimulated genes.
3 secondary outcomes
Correlation between clinical parameters assessed by the Charlson score (comorbidities) and the Fried phenotype (frailty), and the basal blood and nasal interferon score
Time frame: The secondary outcome will be measured at inclusion visit only
Correlation between immune parameters assessed by anti-IFN antibody concentration, concentration of lymphocyte subtypes expressing or not expressing exhaustion markers (Tim-3, PD-1, etc.) and basal blood and nasal interferon score.
Time frame: The secondary outcome will be measured at inclusion visit only
Measurement of nasal IFN-I scores in a population of uninfected vs. infected older individuals (RESPIGERIA study, compliance with MR004 No. 24-5127).
Time frame: The secondary outcome will be measured at inclusion visit only
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 8 Apr 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.
Sophie TROUILLET-ASSANT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uninfected older adults in people with Immunosenescence and Uninfected Older, run by Hospices Civils de Lyon 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 7 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 8 Apr 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 Antoine GARNIER-CRUSSARD (+33 4 72 43 20 50, antoine.garnier-crussard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal IFN-I scores measurement in a non-infected geriatric population. (time frame: The primary outcome will be measured at inclusion visit only). The study lists 2 primary outcomes in all. 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 8 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.