ClinicalTrials.gg
Not yet recruitingNCT07592429POXAIMUpdated May 18, 2026

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

An interventional study of blood sampling in Mpox (Monkeypox), sponsored by ANRS, Emerging Infectious Diseases. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by ANRS, Emerging Infectious Diseases · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed description

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).

02

Conditions studied

  • Mpox (Monkeypox)

Keywords

  • mpox virus
  • Immune protection
  • Immune response
  • Immunity duration
  • Infection
03

In context

Mpox, Monkeypox

72 studies on the registry are indexed under Mpox, Monkeypox; 30 are open to participants now.

This study's planned enrollment of 60 is below the median of 305 across 36 interventional studies indexed under Mpox, Monkeypox.

Browse Mpox, Monkeypox studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written , 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: blood sampling

Interventions

  • Procedureblood sampling

    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.

06

What researchers measure

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)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2026
First posted
May 18, 2026
StartEst.
Jul 1, 2026
Primary completionEst.
Jul 1, 2027
CompletionEst.
Jul 1, 2028
Last update
May 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07592429
Responsible party
Sponsor
First posted
May 18, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
May 18, 2026

Study contacts

Aida TAIEB
Contact
aida.taieb@inserm.fr
+33 (0)1 82 53 35 66

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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