NCT04889573CompletedNot Applicable
Immunoglobulin Gene Rearrangement and Repair in Healthy Donors
University Hospital, Limoges2 sites in 1 country120 target enrollmentStarted: July 7, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Frequency of use of the V, D and J genes in VDJ rearrangements
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Frequency of use of the V, D and J genes in VDJ rearrangements
Time Frame: through study completion, an average of 18 months
Secondary Outcomes
- 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)
- Frequency of g class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions(through study completion, an average of 18 months)
- Nature of HyperMutation Somatic (SHM)(through study completion, an average of 18 months)
Investigators
Study Sites (2)
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