Interferon Reference for Older People - REFIPA 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

Overview

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.

Interventions

• Other Uninfected older adults
  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 sin

Primary outcome measures

• Nasal IFN-I scores measurement in a non-infected geriatric population. [Time frame: The primary outcome will be measured at inclusion visit only]
• Blodd IFN-I scores measurement in a non-infected geriatric population. [Time frame: The primary outcome will be measured at inclusion visit only]

Secondary outcome measures (3)

• 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Hôpital des Charpennes (Hospices Civils de Lyon) — Villeurbanne

Identifiers

NCT: NCT07239830 · 69HCL25_0689

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗