Immunoglobulin Gene Rearrangement and Repair in Healthy Donors (R2IGH)

University of Limoges (UL)

Status: Completed

Conditions: Healthy Volunteers

Treatments: Genetic: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT04889573

87RI20_0074 (R2IGH)

Details and patient eligibility

About

B-cells ensure humoral immune response against antigens (Ag) thanks to their receptor (BCR). V(D)J rearrangement, somatic hypermutation, immunoglobulin (Ig) class switch and locus suicide recombination are mutational/recombinational processes targeting Ig loci influencing BCR expression. Study of these events is essential for B cell function analysis. Our project will provide the normal reference values using high throughput sequencing-based protocols.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers aged between 18 and 70

• volunteers free from lymphoid hemopathy, immune deficiency and autoimmune disease.

  3 categories : volunteers between 18 and 34 years of age, volunteers between 35 and 50 years of age, volunteers between 51 and 69 years of age.

Exclusion criteria

• any recent vaccination (< 4 weeks)

• tumoral pathology

• lymphoïd hemopathy

• immune deficiency

• autoimmune disease

• transplanted patients

• inflammatory / systemic diseases

• hypersensitivity or allergies

• treatments likely to modify the immune response :

  • calcineurin inhibitors: ciclosporin, tacrolimus -antimetabolite: azathioprine, mycophenolate mofetil / mycophenolic acid, 6-mercaptopurine, methotrexate
  • cyclophosphamide
  • antilymphocyte serum (rabbit, horse)
  • mTOR inhibitors: everolimus, sirolimus
  • anti-CD25 (anti IL2-R): basiliximab, dacliximab -belatacept (anti CD80-86)
  • abatacept (CTLA4-Ig)
  • OKT3 (Muronomab-CD3, anti-CD23)
  • glucocorticoids: methylprednisolone, prednisone, prednisolone.
  • entuzumab (anti-CD52)
  • rituximab, ocrelizumab (anti-CD20)
  • eculizumab (anti-C5)
  • anakinra (analogue IL1-RA)
  • leflunomide (dihydroorotate dehydrogenase inhibition)
  • bortezomib (proteasome inhibitor)
  • fingolimod (S1P receptor antagonist)
  • alentuzumab (anti CD52)
  • Ig G -antiTNF (etanercept, infliximab, adalimumab, certolizumab)
  • vedolizumab (Anti-integrin α4β7 Ab)
  • ustekinumab (anti-IL12)
  • natalizumab (anti-integrin a4)
  • mitoxantrone (topoisomerase type II inhibitor)
  • tocilizumab (anti-IL6)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Blood sample

Experimental group

Treatment:

Genetic: Blood sample