Long-term monitoring of adults with type I interferon autoantibodies or genetic interferon defects
Impaired Type I IFN Immunity Due to Autoantibodies or a Genetic Defect: a Prospective National Cohort
We will follow adults who have autoantibodies to type I interferons or genetic defects that impair interferon responses to see if they develop more infections or autoimmune problems and how antibody levels change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 9 sites (Lille and 8 other locations) |
| Trial ID | NCT06762002 on ClinicalTrials.gov |
What this trial studies
This prospective national cohort will enroll adults known to carry neutralizing autoantibodies against type I interferons or to have inherited defects affecting type I IFN production or signaling. Participants will provide serial blood samples and undergo clinical follow-up to record infectious and autoimmune events and to measure the kinetics and neutralizing activity of the autoantibodies. The study is observational and non-interventional, conducted at specialist centers in Lille, Lyon and Montpellier, France. Data will be used to improve understanding of risk patterns and to inform prevention and management strategies for affected individuals.
Who should consider this trial
Good fit: Adults over 18 with documented type I interferon–neutralizing autoantibodies or a genetic defect impairing type I IFN production or response, who can give informed consent and are covered by French social security, are ideal candidates.
Not a fit: People without such autoantibodies or genetic defects, those with a life expectancy under one year, or those enrolled in an interventional pharmacological trial are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the project could help identify who is at higher risk for severe infections or autoimmunity and guide prevention and personalized care.
How similar studies have performed: Previous observational work identified type I IFN–neutralizing autoantibodies in about 15% of severe COVID-19 cases and inborn errors affecting IFN responses in about 4%, but prospective longitudinal follow-up of these patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * History of carrying 1) auto-Abs against type I IFNs or 2) IEI impairing the response to, or the production of, type I IFNs (IFN-I-IEI) * Affiliated to social security * Written informed consent Exclusion Criteria: * Participation to an interventional clinical trial on a pharmacological treatment * Clinical condition leading to life expectancy less than 1 year * Subject to a legal protection measure (safeguard of justice, curatorship, tutorship) * Individuals deprived of freedom
Where this trial is running
Lille and 8 other locations
- Cic Lille — Lille, France (Recruiting)
- Lyon Hcl — Lyon, France (Recruiting)
- Cic Montpellier — Montpellier, France (Recruiting)
- Cic Bichat — Paris, France (Recruiting)
- Cic Creteil — Paris, France (Recruiting)
- Cic La Salpetriere — Paris, France (Recruiting)
- Cic Necker — Paris, France (Recruiting)
- Cic St Louis — Paris, France (Recruiting)
- Cic Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Xavier-Marie DUVAL, PU-PH
- Email: xavier.duval@aphp.fr
- Phone: 01 40 25 71 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.