Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Genetic: Blood sample

• Registration Number: NCT04889573
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-14
• Study First Posted: 2021-05-17
• Study Start: 2021-07-07
• Status Verified: 2021-10
• Primary Completion: 2021-10-14
• Study Completion: 2021-10-14
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sample	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Frequency of use of the V, D and J genes in VDJ rearrangements	through study completion, an average of 18 months

Secondary Outcome Measures

Name	Time	Method
Percentage of HyperMutation Somatic (SHM) in VDJ regions	through study completion, an average of 18 months
Ig class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions	through study completion, an average of 18 months	number of CSR and LSR junctions
Frequency of g class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions	through study completion, an average of 18 months	frequency of CSR and LSR junctions according to their structure
Nature of HyperMutation Somatic (SHM)	through study completion, an average of 18 months	transitions and transversions

Trial Locations

Locations (1)

Limoges University Hospital; 🇫🇷 Limoges, France