Assessment of Immune Memory - Humoral and Cellular - in mPOX-infected Patients : an Ancillary Study of the ANRS0258s MOSAIC Cohort
Starting soon · Not applicable
Conditions studied: Mpox (Monkeypox)
In brief
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 1. 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. 2. Assess the breadth of the B-cell repertoire and its neutralizing capacity in a subset of patients 3. 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 1. The presence of MPXV antigen-specific B-cell memory. Memory B cells will be measured by flow cytometry and other techniques. 2. The breadth and neutralizing capacity of the B-cell repertoire in a subset of patients. 3. The humoral immunity using serological techniques.
Key facts
- Study ID
- NCT07592429
- Run by
- ANRS, Emerging Infectious Diseases
- People needed
- 60
- Starts
- 2026-07-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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