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临床试验/NCT06853886
NCT06853886招募中不适用

Gene Discovery in CHB Patients to Identify Unknown Pathways That Lead to B and NK Cell Deregulation

University Hospital, Limoges6 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年8月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
140
试验地点
6
主要终点
RNA sequencing of B cells from CHB patients at different stages, description of their molecular signature

研究概览

简要总结

Natural Killer (NK) and B cell immune responses occur during the early stages of infection and are essential to eradicate it. Yet, chronic hepatitis B (CHB) infection occurs because the antiviral immune response is insufficient. In both NK and B cell studies we will explore the genetic alterations that occur during the varied chronic stages of the disease. We believe that our findings will allow us to understand the molecular signature of NK and B cells in the context of HBV infection.

详细描述

Thanks to past ANRS funding we showed that both B and NK cells are dysfunctional in Hepatitis B virus (HBV) in in vitro human models and validated in patients with chronic infection. We observed that B cells responses by Toll Like Receptor 9 (TLR9) were inhibited by the HBV viral protein HBsAg. We noted the loss of TLR9 expression on all B cell subsets by HBV was mediated by loss of its promoter activity by blocking the phosphorylation of the transcription factor CREB (pCREB). Furthermore, B cell-TLR9 mediated responses such as proliferation and cytokine production were abrogated in CHB patients. For NK cells we demonstrated several significant changes in their receptor expression, loss of cytokines IFN γ, MIP1a and cytotoxicity compared to healthy donors. However, for both NK and B cell dysfunction the molecular basis and signaling pathway of this phenomenon are poorly characterized and whether this state can be reversed, a question of therapeutic importance, is unknown. We hypothesize that several molecular changes occur in NK cells from CHB patients that depend on altering the mTOR pathway by HBV and more specifically by HBsAg. Together our results from this proposal should define the genetic signatures that lead to B and NK cell function and will contribute to our understanding on immune dysfunction by HBV. In both NK and B cell studies we will explore the genetic alterations that occur during the varied chronic stages of the disease. This can only be investigated in patients including all clinical stages of CHB.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or female, age ≥18 years old
  • •HBV infection or chronic HBV infection untreated or treated with a nucleoside or nucleotide analog
  • •Willing and able to provide written informed consent
  • •Affiliated with a social securityregimen
  • •Healthy volunteer must meet all of the following inclusion criteria to be eligible for participation in this study:
  • •Male or female, age between 18 and 80 years
  • •Willing and able to provide written informed consent

排除标准

  • •Co-infection with HCV, HIV or HDV (or HBV for healthy volunteer)
  • •Acute hepatitis in the year preceding recruitment
  • •Other liver diseases : alcohol, obesity (BMI>30), diabetes, metabolic syndrome (dyslipidemia and/or known hypertension) - Underlying immunological or cancerous diseases
  • •Patient with a disability that prevents him/her from fully understanding the requirements of the trial - Patient under court protection, guardianship or curatorship
  • •Pregnant or breast-feeding women.
  • •Secondary exclusion criteria:
  • •A healthy volunteer whose vaccination status does not match that expected on the basis of serological results
  • •Positive blood pregnancy test on inclusion
  • •Positive HCV, HIV or HDV test in a patient
  • •Positive HBV, HCV, HIV or HDV test in a healthy volunteer

研究组 & 干预措施

HBV patient

Other

a blood sample is done during a follow-up visit

干预措施: blood sample HBV patient (Other)

healthy volunteers

Other

a blood sample

干预措施: blood sample healthy volunteers (Other)

结局指标

主要结局

RNA sequencing of B cells from CHB patients at different stages, description of their molecular signature

时间窗: At inclusion, day 0

次要结局

  • RNA sequencing of NK cells from CHB patients at different stages, description of their molecular signature (protein expression measured by flow cytometry)(At inclusion, day 0)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (6)

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