NCT07534267

Brief Summary

This study has three primary objectives to address the public health challenges of the Mpox outbreak in Guinea, West Africa. Objective 1 (MOVIE-West Africa) focuses on understanding the kinetics of Monkeypox virus (MPXV) elimination from the human body in Mpox cases. Objective 2 (TRACE-West Africa) aims to determine the MPXV transmission dynamics between Mpox cases and their contacts. Objective 3 (VE-West Africa) examines the vaccine effectiveness of the MVA-BN vaccine in protection against MPXV infection and Mpox disease.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
992

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

April 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 16, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

MpoxMonkeypoxMPXVtransmission dynamicsvaccine effectivenesssecondary attack rateMVA-BNGuineasub-Saharan AfricaWest AfricaMOVIE-TRACEviral clearance

Outcome Measures

Primary Outcomes (3)

  • Viral clearance in oropharyngeal swabs

    Time to viral clearance in oropharyngeal swabs (number of days from onset of symptoms to first negative PCR result).

    From day 1 to day 56

  • Secondary attack rate of infection

    Estimation of Secondary Attack Rate of infection (SAR-i), the proportion of contacts who become infected (PCR positive), regardless of exhibiting symptoms.

    From day 1 to day 14

  • Secondary attack rate of disease

    Estimation of Secondary attack rate of disease (SAR-d), the proportion of contacts who become infected (PCR positive) and develop symptoms.

    From day 1 to day 28

Secondary Outcomes (4)

  • Viral clearance in skin lesions

    From day 1 to day 56

  • Viral clearance in urine

    From day 1 to day 56

  • Risk factors of transmission

    From day 1 to day 14

  • Immunological assessments

    From day 1 to day 56

Study Arms (3)

MOVIE

Confirmed Mpox cases

TRACE

Contacts of a MOVIE case

VE

Confirmed Mpox cases and their contacts

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All individuals regardless of age or sex, who either have confirmed MPXV infection or have close contacts with a confirmed Mpox case.

You may qualify if:

  • MOVIE-West Africa
  • Individuals of any sex and age.
  • Confirmed Mpox cases who tested positive for MPXV by PCR.
  • Symptom onset within the 10 days prior to the baseline assessment.
  • Willingness and ability to comply with study procedures and attend scheduled follow-up visits for up to two months.
  • Availability for follow-up throughout the study period.
  • Provision of written informed consent by the participant, or consent by a legally authorized representative for minors or individuals unable to provide it themselves.
  • Assent obtained from children aged 12 to 17 years.
  • For individuals who cannot read or write, witnessed consent will be obtained.
  • TRACE-West Africa
  • Individuals who have had close physical contact with a PCR-confirmed Mpox case within 14 days from the onset of symptoms in the index case.
  • Close physical contact is defined as being within 2 meters of an infected person-particularly in enclosed spaces-for at least 5 minutes (based on CDC's 2-meter rule for droplet transmission).
  • Willingness and ability to comply with the study protocol and attend scheduled follow-up assessments.
  • Provision of written informed consent by the participant, or consent by a legally authorized representative for individuals unable to provide it themselves.
  • Assent obtained from children aged 12 to 17 years.
  • +9 more criteria

You may not qualify if:

  • (1) MOVIE-West Africa
  • Cases of severe Mpox requiring hospitalization.
  • Individuals with a confirmed alternative diagnosis explaining their illness.
  • (3) VE-West Africa
  • Cases of severe Mpox requiring hospitalization.
  • Individuals with a confirmed alternative diagnosis explaining their illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre National de Formation et de Recherche en Sante Rurale de Maferinyah

Conakry, Guinea

Location

Related Publications (3)

  • Suner C, Ubals M, Tarin-Vicente EJ, Mendoza A, Alemany A, Hernandez-Rodriguez A, Casan C, Descalzo V, Ouchi D, Marc A, Rivero A, Coll P, Oller X, Miguel Cabrera J, Vall-Mayans M, Dolores Folgueira M, Angeles Melendez M, Agud-Dios M, Gil-Cruz E, Paris de Leon A, Ramirez Marinero A, Buhiichyk V, Galvan-Casas C, Paredes R, Prat N, Sala Farre MR, Bonet-Simo JM, Farre M, Ortiz-Romero PL, Clotet B, Garcia-Patos V, Casabona J, Guedj J, Cardona PJ, Blanco I; Movie Group; Marks M, Mitja O. Viral dynamics in patients with monkeypox infection: a prospective cohort study in Spain. Lancet Infect Dis. 2023 Apr;23(4):445-453. doi: 10.1016/S1473-3099(22)00794-0. Epub 2022 Dec 12.

    PMID: 36521505BACKGROUND
  • Tarin-Vicente EJ, Alemany A, Agud-Dios M, Ubals M, Suner C, Anton A, Arando M, Arroyo-Andres J, Calderon-Lozano L, Casan C, Cabrera JM, Coll P, Descalzo V, Folgueira MD, Garcia-Perez JN, Gil-Cruz E, Gonzalez-Rodriguez B, Gutierrez-Collar C, Hernandez-Rodriguez A, Lopez-Roa P, de Los Angeles Melendez M, Montero-Menarguez J, Munoz-Gallego I, Palencia-Perez SI, Paredes R, Perez-Rivilla A, Pinana M, Prat N, Ramirez A, Rivero A, Rubio-Muniz CA, Vall M, Acosta-Velasquez KS, Wang A, Galvan-Casas C, Marks M, Ortiz-Romero PL, Mitja O. Clinical presentation and virological assessment of confirmed human monkeypox virus cases in Spain: a prospective observational cohort study. Lancet. 2022 Aug 27;400(10353):661-669. doi: 10.1016/S0140-6736(22)01436-2. Epub 2022 Aug 8.

    PMID: 35952705BACKGROUND
  • Mitja O, Ogoina D, Titanji BK, Galvan C, Muyembe JJ, Marks M, Orkin CM. Monkeypox. Lancet. 2023 Jan 7;401(10370):60-74. doi: 10.1016/S0140-6736(22)02075-X. Epub 2022 Nov 17.

    PMID: 36403582BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood, lesion swab, oropharyngeal swab, urine, vaginal swab, rectal swab

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsPrimate DiseasesAnimal DiseasesRodent Diseases

Study Officials

  • Edward M Choi, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR
  • Michael E Marks, PhD

    London School of Hygiene and Tropical Medicine

    STUDY CHAIR
  • Oriol Mitjà, PhD

    Fundación FLS de lucha contra el sida las enfermedades infecciosas y la promoción de la salud y la ciencia, Spain

    STUDY CHAIR
  • Deborah Watson-Jones, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
56 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 16, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations