About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
blood sampling
Procedure/SurgeryProcedure: 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Locations
Sponsors and contacts
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ANRS, Emerging Infectious Diseases
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborator
This trial is not recruiting at the moment. You can still explore other options: