Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

Healthy Volunteers Clinical Trial

— R2IGH  

Official title:

Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889573
• Other study ID #: 87RI20_0074 (R2IGH)
• Status: Completed
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: October 14, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 a4ß7 Ab)

• ustekinumab (anti-IL12)

• natalizumab (anti-integrin a4)

• mitoxantrone (topoisomerase type II inhibitor)

• tocilizumab (anti-IL6)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Genetic:
• Blood sample
The blood samples will be collected from healthy volunteers : 7 tubes of 7 ml with anti-coagulant Héparine Lithium and 1 tube of 7ml with anti-coagulant EDTA

Locations

Country	Name	City	State
France	Limoges University Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of use of the V, D and J genes in VDJ rearrangements		through study completion, an average of 18 months
Secondary	Percentage of HyperMutation Somatic (SHM) in VDJ regions		through study completion, an average of 18 months
Secondary	Nature of HyperMutation Somatic (SHM)	transitions and transversions	through study completion, an average of 18 months
Secondary	Ig class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions	number of CSR and LSR junctions	through study completion, an average of 18 months
Secondary	Frequency of g class switching (CSR) and recombination suicide of the IgH locus (LSR) junctions	frequency of CSR and LSR junctions according to their structure	through study completion, an average of 18 months