Peripheral Helper T-cells in Common Variable ImmunoDeficiency
ConditionCommon Variable Immunodeficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
The aim is to determine whether whether Tph could support non-infectious complications through providing help to pathological B-cells.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
blood sample
Other intervention48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Common variable immunodeficiencyExperimental treatment 1 intervention
Group B: ControlsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ability of Tph to promote differentiation and antibody production by memory B cells (B-T co-culture)
Time frame
At baseline (Day 0)Sponsors and contacts
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Source ClinicalTrials.gov