ClinicalTrials.gg
RecruitingNCT07255157TAPDIUpdated Aug 5, 2026

Peripheral Helper T-cells in Common Variable ImmunoDeficiency

An interventional study of blood sample in Common Variable Immunodeficiency, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim is to determine whether whether Tph could support non-infectious complications through providing help to pathological B-cells.

Read the detailed description

Common variable immunodeficiency (CVID), the most common symptomatic primary immunodeficiency in adults, can associate recurrent infections with severe non-infectious complications. Unfortunately, there is still no absolute biomarker predicting which CVID patient will develop non-infectious complications. Thus, novel biomarkers which could help refining CVID patient prognosis require further investigations. Moreover, the immune mechanisms driving non-infectious complications remain elusive. Therefore, further insight into CVID pathophysiology is needed to discover new treatments for CVID patients with non-infectious complications (CVIDc). The preliminary results show that CVIDc patients have an increase of circulating peripheral helper T-cells (Tph) , in comparison with patients with infectious manifestations only (CVIDi) and healthy individuals (HI). Recently described, Tph express CXCR3, help memory B-cells and are found in inflamed tissues in auto-immune diseases. They represent a major reservoir of auto-reactive T-cells, suggesting that Tph are key to drive auto-immune processes. Some authors hypothesized that Tph can help atypical memory B-cells (ABCs), a B-cell subset which is involved in auto-immune disease pathophysiology and which is also expanded in CVIDc patients. The investigators observed that CXCR3+ cells were increased in the spleen of CVIDc patients in comparison with non-CVID controls. These CXCR3+ cells could correspond to Tph supporting extra-follicular reaction and then B-cell tolerance loss. The hypothesis is that alterations in T-B cell collaboration leads to the amplification of Tph in CVID patients. Tph could support non-infectious complications in target tissues through providing help to pathological B-cells such as ABCs. Using peripheral blood from CVIDc/CVIDi patients and HI, the investigators will determine whether Tph support pathological B cell activation in CVIDc patients using T-B co-cultures. Patients will be included during their routine follow-up, for one day.

02

Conditions studied

  • Common Variable Immunodeficiency

Keywords

  • common variable immunodeficiency
  • peripheral helper T cells
  • B cells
03

In context

Common Variable Immunodeficiency

54 studies on the registry are indexed under Common Variable Immunodeficiency; 13 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 39 interventional studies indexed under Common Variable Immunodeficiency.

Browse Common Variable Immunodeficiency studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Patients on and/or ;
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Common variable immunodeficiency

    Other: blood sample

  • Active comparator
    Controls

    Healthy controls

    Other: blood sample

Interventions

  • Otherblood sample

    48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation

06

What researchers measure

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)

07

Study locations

1 of 1 sites recruiting
  • CHU de Bordeaux - service de médecine interne
    Pessac, France
    Recruiting
    • Jean-François VIALLARD, Prof · Contactjean-françois.viallard@chu-bordeaux.fr · (0)5.57.65.64.83
    • Carine LOPEZ · Contactcarine.lopez@chu-bordeaux.fr · (0)5.24.54.91.32
    • Jean-François VIALLARD, Prof · Principal investigator
    • Estibaliz LAZARO, Prof · Sub investigator
    • Carine GREIB, MD · Sub investigator
    • Camille PROT-LEURENT, MD · Sub investigator
    • Pierre DUFFAU, Prof · Sub investigator
    • Emmanuel RIBEIRO, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Jan 2028, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2025
First posted
Nov 28, 2025
StartActual
Jul 9, 2026
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Aug 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07255157
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Jul 9, 2026
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Aug 5, 2026

Study contacts

Jean-François VIALLARD, Prof
Contact
jean-françois.viallard@chu-bordeaux.fr
(0)5.57.65.64.83 ext. +33
Carine LOPEZ
Contact
carine.lopez@chu-bordeaux.fr
(0)5.24.54.91.32 ext. +33
Jean-François VIALLARD, Prof
principal investigator · University Hospital, Bordeaux
Jonathan VISENTIN, Prof
study director · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion