Assessment of Immune Memory - Humoral and Cellular - in mPOX-infected Patients : an Ancillary Study of the ANRS0258s MOSAIC Cohort (POXAIM)
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.
연구 개요
상세 설명
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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Aida TAIEB
- 전화번호: +33 (0)1 82 53 35 66
- 이메일: aida.taieb@inserm.fr
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: study population
Procedure: Patients included in the ANRS0758s MOSAIC cohort will be recalled >3 years after their infection to come to hospital to have a review of medical history since mpox infection, a clinical examination in case of symptoms suggestive of a mpox infection and samples taken for the study.
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Procedure: Patients included in the ANRS0758s MOSAIC cohort will be recalled >3 years after their infection to come to hospital to have a review of medical history since mpox infection, a clinical examination in case of symptoms suggestive of a mpox infection and samples taken for the study.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The main outcomes are: the presence of neutralizing antibodies in the serum and the presence of detectable mpox virus-specific memory B cells.
기간: Baseline (Day 1)
|
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.
|
Baseline (Day 1)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ANRS0791s POXAIM
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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