Status:

COMPLETED

Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

Lead Sponsor:

University Hospital, Limoges

Conditions:

Healthy Volunteers

Eligibility:

All Genders

18-70 years

Phase:

NA

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 recombinatio...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

July 7 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 14 2021

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT04889573

Start Date

July 7 2021

End Date

October 14 2021

Last Update

July 30 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Limoges University Hospital

Limoges, France, 87200

Immunoglobulin Gene Rearrangement and Repair in Healthy Donors | DecenTrialz