Assessment of Immune Memory - Humoral and Cellular - in mPOX-infected Patients : an Ancillary Study of the ANRS0258s MOSAIC Cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
Primary objective The overall objective is to assess the long-term amplitude and durability of the immune responses after mpox virus (MPXV) infection.
Primary endpoint The main outcomes are: the presence of neutralizing antibodies in the serum and the presence of detectable mpox virus-specific memory B cells. Neutralizing antibodies titers will be measured with a semi-automated cell-based assay using live mpox virus. Memory B cells will be measured by flow cytometry and other techniques.
Secondary objectives
- Assess the amplitude and the stability of the MPXV antigen-specific B-cell memory response after infection, against the immunodominant antigens A27, A33, B5, L1, D8, and H3.
- Assess the breadth of the B-cell repertoire and its neutralizing capacity in a subset of patients
- Assess the humoral immunity using different serological techniques, for the detection and quantification of anti-MPXV antibodies, and assess the seroneutralization capacities of each antibody.
Secondary endpoints
- The presence of MPXV antigen-specific B-cell memory. Memory B cells will be measured by flow cytometry and other techniques.
- The breadth and neutralizing capacity of the B-cell repertoire in a subset of patients.
- The humoral immunity using serological techniques.
详细描述
Single inclusion visit with data collection and blood sample. No further follow-up of participants.
A total of 60 participants previously enrolled in the main cohort ANRS 0758s MOSAIC are planned to be included, distributed among France (n = 35), Italy (n = 20), and Switzerland (n = 5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Written informed consent, signed by the participant and the investigator prior to any study-related procedure
- •Person previously enrolled in the ANR0258s-MOSAIC cohort (see Appendix 19.2 for MOSAIC inclusion criteria) between July 2022 and July 2023
- •Person with a blood sample taken within 8 months following mpox infection
- •≥ 18 years old
排除标准
- •Individuals who, in the investigator's opinion, are unlikely to comply with study procedures or whose medical condition is incompatible with study participation
- •For France only: person not affiliated to or not benefiting from a social security scheme in accordance with article L1121-11 of the French Public Health Code (Aide Médicale d'Etat [AME] does not constitute a social security scheme)
- •Pregnant or breastfeeding women
- •Individuals under guardianship or curatorship, or deprived of liberty by judicial or administrative decision