NCT06885853

Brief Summary

This study is to evaluate the long-term immunogenicity of a boost dose of MVA-BN vaccine

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
May 2025Nov 2027

First Submitted

Initial submission to the registry

March 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 7, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

March 13, 2025

Last Update Submit

May 14, 2025

Conditions

Monkeypox

Keywords

MonkeypoxMVA-BN booster vaccineHIV pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity a of a booster dose of MVA-BN vaccine

    To evaluate the immunogenicity at 12 months of a booster dose of MVA-BN vaccine administered subcutaneously in HIV PrEP users.

    12 months

Secondary Outcomes (3)

  • Persistence of humoral immunogenicity

    24 months

  • Kinetics of the humoral response

    24 months

  • Description of cases of Mpox infection

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of Men who have Sex with Men (MSM), taking HIV pre-exposure prophylaxis (HIV PrEP), eligible for MVA-BN vaccination.

You may qualify if:

  • Men aged over 18 years
  • Have received two doses of MVA-BN vaccine as an initial schedule
  • Eligible for a booster dose of MVA-BN (according to the HAS recommendation)
  • Be eligible and wish to initiate PrEP-HIV treatment or be followed for PrEP-HIV treatment
  • Covered by social security (excluding AME)

You may not qualify if:

  • History of mpox (virologically confirmed)
  • Be under guardianship or curatorship
  • Be subject to a judicial protection measure
  • Have a contraindication to vaccination against mpox

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC 1417Cochin-Pasteur

Paris, Paris, 75679, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsPrimate DiseasesAnimal DiseasesRodent Diseases

Study Officials

  • Liem Binh Luong Nguyen, Degree medical doctor

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liem Binh Luong Nguyen, Degree medical doctor

CONTACT

0033 1 58 41 28 58liem.luong@aphp.fr

Odile LAUNAY, PUPH

CONTACT

0033 1 58 41 28 58odile.launay@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 20, 2025

Study Start

May 7, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)