Peripheral helper T-cells in CVID

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Common variable immunodeficiency (CVID) is a primary immune disorder with recurrent infections and sometimes non-infectious complications. The study will analyze blood samples to explore the role of peripheral helper T-cells (Tph) in CVID, particularly in patients with non-infectious complications. The goal is to identify how Tph cells interact with B cells and whether they could serve as biomarkers or therapeutic targets. No experimental treatment is being given to participants beyond blood collection, and eligibility focuses on adults diagnosed with CVID. Results could improve understanding of CVID pathophysiology and inform future interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female;
* Age ≥ 18 years;
* Standard criteria will be applied to diagnose CVID, specifically requiring: 1) low serum IgG level \<5 g/L, combined with low IgM- and/or IgA-isotype concentrations \<0.4 g/L or \<0.7 g/L, respectively; 2) poor antibody responses to immunization or infection; and 3) exclusion of other defined forms of secondary hypogammaglobulinemias. Patients meeting the definitional criteria for CVID will be included, regardless of the duration of the disease or the treatment received (gammaglobulins substitution or not);
* Being affiliated to health insurance;
* Willing to participate and to sign informed consent.

Exclusion Criteria:

* Patients on corticosteroids and/or immunosuppressants;
* Patients with a primary immunodeficiency genetically characterized, such as Bruton disease our HyperIgM syndrome;
* Patients with an active chronic infection;
* Pregnant or breastfeeding women;
* Persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent.

Where it's running

• CHU de Bordeaux - service de médecine interne
  Pessac, France Recruiting

Study contacts

• Principal investigator: Jean-François VIALLARD, Prof — University Hospital, Bordeaux
• Study coordinator: Jean-François VIALLARD, Prof
• Email: jean-françois.viallard@chu-bordeaux.fr
• Phone: (0)5.57.65.64.83

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.