Assessment of Immune Memory - Humoral and Cellular - in mPOX-infected Patients : an Ancillary Study of the ANRS0258s MOSAIC Cohort

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • blood sampling

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: study populationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Day 1)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: