Assessment of Immune Memory - Humoral and Cellular - in mPOX-infected Patients : an Ancillary Stu… (NCT07592429) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessment of Immune Memory - Humoral and Cellular - in mPOX-infected Patients : an Ancillary Study of the ANRS0258s MOSAIC Cohort
60 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The main outcomes are: the presence of neutralizing antibodies in the serum and the presence of detectable mpox virus-specific memory B cells.