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Mpox (Monkeypox)MOVIE-TRACE-WANCT07534267

Understanding MPXV Viral Clearance, Transmission Dynamics, and Mpox Vaccine Effectiveness in West Africa : Guinea

An observational study of Mpox (Monkeypox) and Monkeypox, run by London School of Hygiene and Tropical Medicine at 1 site in Guinea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Mpox (Monkeypox), Monkeypox
How many people
992 participants
Where
1 siteGuinea
Study dates
16 Apr 2026to Aug 2027
How long will I take part?
56 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.
Show all 26Show fewer
  • 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.
  • For individuals who cannot read or write, witnessed consent will be obtained.
  • VE-West Africa
  • The inclusion criteria for Mpox cases in VE-West Africa are same as those in MOVIE-West Africa.
  • The inclusion criteria for contacts of Mpox cases in VE-West Africa are as follows.
  • 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).
  • Individuals living, working or studying in a community where mpox vaccination is being offered.
  • 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.
  • For individuals who cannot read or write, witnessed consent will be obtained.

Who cannot join

  • MOVIE-West Africa
  • Cases of severe Mpox requiring hospitalization.
  • Individuals with a confirmed alternative diagnosis explaining their illness.
  • VE-West Africa
  • The exclusion criteria for Mpox cases in VE-West Africa are as follows.
  • Cases of severe Mpox requiring hospitalization.
  • Individuals with a confirmed alternative diagnosis explaining their illness.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Edward M Choi, PhD contact

+44 20 7636 8636

edward.choi@lshtm.ac.uk

Deborah Watson-Jones, PhD contact

+44 20 7636 8636

deborah.watson-jones@lshtm.ac.uk

Guinea1 site

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

    Conakry

    Abdoul H Beavogui, PhD, +224 628 04 53 52, bea@maferinyah.org

    Abdoul H Beavogui, MD, PhD

Other trials in Guinea

About this study

Official title: Understanding MPXV Viral Clearance in Mpox Patients and Evaluating Transmission Dynamics of MPXV and Mpox Vaccine Effectiveness in West Africa : The Republic of Guinea

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.

Read the detailed description

A new outbreak of clade 2b Monkeypox virus (MPXV) was first documented in Guinea in September 2024. This outbreak has a great potential to spread through intimate contact and sexual activity. The public health response to date has focused on reporting and isolation of confirmed cases, contact tracing and testing. In 2025, a donation of the JYNNEOS (modified vaccinia Ankara-Bavaria Nordic; MVA-BN) vaccine was provided to Guinea. It is a live attenuated vaccine licensed as a two-dose vaccine for prevention of Mpox infection. Due to limited vaccine supplies, many governments in West Africa have focused on giving out one dose of the vaccine to individuals at risk.

There is a dearth of information regarding transmission dynamics for clade 2b and vaccine effectiveness in endemic settings in West Africa, in populations with a high prevalence of other comorbidities and infections such as malaria. Given the current mpox outbreak's public health significance for Guinea, there is a need for comprehensive research in this endemic setting to better understand disease pathogenesis, transmission dynamics and effective control and prevention measures for clade 2b outbreaks. We have an opportunity to conduct this key research now to inform the public health measures for the current Guinea Mpox outbreak.

This study has three linked objectives to address the public health challenge of Mpox in Guinea. Objective 1 (MOVIE-West Africa) focuses on understanding the kinetics of viral elimination, shedding light on how MPXV interacts with host tissues and immune defense, and informing endpoint selection for therapeutic trials. This is important because currently there are significant data gaps in MPXV viral dynamics and transmission patterns to inform control measures for clade 1a and clade 2b in endemic settings. There are no data regarding the dynamics of viral clearance in clade 2b cases from endemic countries in West Africa. Understanding the kinetics of viral clearance is crucial for advising the Guinea government and other countries on clinical management practice and the duration of isolation protocols.

Objective 2 (TRACE-West Africa) aims to determine the secondary attack rate (SAR), assessing host susceptibility and offering vital data to target interventions towards vulnerable groups and informing vaccine efforts by contributing to the assessment of vaccine efficacy endpoints. Understanding the SAR has important implications for controlling the outbreak. By quantifying the risk of secondary transmission, SAR data can guide decisions on the prioritization of contact tracing efforts, deployment of healthcare personnel, distribution of medical supplies to mitigate further infections and inform development and adjustment of isolation and quarantine policies. High SAR values suggest a greater likelihood of secondary transmission, prompting stricter isolation measures and longer quarantine periods for contacts of mpox cases. Conversely, low SAR values may indicate that existing control measures are effective, allowing for more targeted interventions.

Objective 3 (VE-West Africa) examines the vaccine effectiveness of the MVA-BN vaccine in protection against MPXV infection and Mpox disease. The JYNNEOS vaccine is recommended as a prophylactic two-dose regimen for maximum protection against MPXV infection. Given the limited global vaccine supply, the country has taken a decision to proceed with an alternative one-dose schedule for at-risk individuals. This study will use the opportunity to measure MVA-BN vaccine effectiveness against clade 2b, the first time that this is being conducted in a clade 2b Mpox endemic country in sub-Saharan Africa. Importantly, our SAR data will be instrumental for this third objective and for future vaccine efficacy trials and vaccination campaigns and will help guide decisions on the deployment and prioritization of vaccines in Mpox outbreaks.

The MOVIE-TRACE-West Africa study will generate comprehensive evidence on clade 2b MPXV viral clearance, transmission pattern and vaccine effectiveness to guide rapid response and control policies in Guinea and other Mpox affected countries.

Keywords
Mpox, Monkeypox, MPXV, transmission dynamics, vaccine effectiveness, secondary attack rate, MVA-BN, Guinea, sub-Saharan Africa, West Africa, MOVIE-TRACE, viral clearance
Medical subject headings
Mpox, Monkeypox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07534267
Study groupRoleWhat they receive
MOVIEConfirmed Mpox cases
TRACEContacts of a MOVIE case
VEConfirmed Mpox cases and their contacts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Viral clearance in oropharyngeal swabs

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

    Measured: From day 1 to day 56

  2. 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.

    Measured: From day 1 to day 14

  3. 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.

    Measured: From day 1 to day 28

Secondary outcomes (4)

  1. Viral clearance in skin lesions

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

    Measured: From day 1 to day 56

  2. Viral clearance in urine

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

    Measured: From day 1 to day 56

  3. Risk factors of transmission

    Identification of factors that influence the risk of transmission

    Measured: From day 1 to day 14

  4. Immunological assessments

    Measurement of MPXV-specific antibodies by immunoassays

    Measured: From day 1 to day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study start16 Apr 2026 (estimated)
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
992 participants (estimated)
Target duration
56 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07534267
Sponsor's protocol ID
MOVIE-TRACE-West Africa
Other IDs
UKRI2532
Acronym
MOVIE-TRACE-WA
Status last verified
Apr 2026
First submitted
10 Apr 2026
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data (IPD) will be shared under reasonable request

Publications

  • 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.

    PubMed 36521505

  • 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.

    PubMed 35952705

  • 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.

    PubMed 36403582

Questions about this trial

What is this clinical trial studying?

An observational study of Mpox (Monkeypox) and Monkeypox, run by London School of Hygiene and Tropical Medicine at 1 site in Guinea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edward M Choi, PhD (+44 20 7636 8636, edward.choi@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Viral clearance in oropharyngeal swabs (time frame: From day 1 to day 56). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07534267, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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