NCT07239830

Interferon Reference for Older People - REFIPA Study

Reference Values Determination of Nasal and Blood Interferon Scores in Uninfected Older Subjects REFérence Interféron Older Subjects (Older People Interferon Reference) - REFIPA Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Immunosenescence
• Uninfected Older

Interventions

Type	Name	Description
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 single visit. A biological collection will be created with the participant's specific consent, using leftover blood and nasopharyngeal swabs after testing.

Timeline

• Start date: 2025-12-02
• Primary completion: 2026-12-03
• Completion: 2026-12-03
• First posted: 2025-11-20
• Last updated: 2026-04-08

Locations

1 site across 1 country: France