ClinicalTrials.gg
Not yet recruitingNCT07534267MOVIE-TRACE-WAUpdated Apr 16, 2026

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

An observational study in Mpox (Monkeypox) and Monkeypox, sponsored by London School of Hygiene and Tropical Medicine. Not yet recruiting at 1 site in Guinea. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by London School of Hygiene and Tropical Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
992
Sex
All
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Study 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.

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.

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Conditions studied

  • Mpox (Monkeypox)
  • Monkeypox

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Keywords

  • Mpox
  • Monkeypox
  • MPXV
  • transmission dynamics
  • vaccine effectiveness
  • secondary attack rate
  • MVA-BN
  • Guinea
  • sub-Saharan Africa
  • West Africa
  • MOVIE-TRACE
  • viral clearance
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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 992 is above the median of 224 across 34 observational studies indexed under Mpox, Monkeypox.

Browse Mpox, Monkeypox studies →

Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

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

  1. 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 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.
  2. 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.
  3. 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.

Exclusion criteria

Exclusion Criteria:

(1) MOVIE-West Africa

  • Cases of severe Mpox requiring hospitalization.
  • Individuals with a confirmed alternative diagnosis explaining their illness.

    (3) 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.
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

Observational model
Cohort
Time perspective
Prospective
Enrollment
992 participants (estimated)
Target follow-up
56 Days
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • MOVIE

    Confirmed Mpox cases

  • TRACE

    Contacts of a MOVIE case

  • VE

    Confirmed Mpox cases and their contacts

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What researchers measure

Primary outcomes

  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).

    Time frame: 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.

    Time frame: 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.

    Time frame: From day 1 to day 28

Secondary outcomes

  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).

    Time frame: 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).

    Time frame: From day 1 to day 56

  3. Risk factors of transmission

    Identification of factors that influence the risk of transmission

    Time frame: From day 1 to day 14

  4. Immunological assessments

    Measurement of MPXV-specific antibodies by immunoassays

    Time frame: From day 1 to day 56

07

Study locations

1 site
  • Centre National de Formation et de Recherche en Sante Rurale de Maferinyah
    Conakry, Guinea
    • Abdoul H Beavogui, PhD · Contactbea@maferinyah.org · +224 628 04 53 52
    • Abdoul H Beavogui, MD, PhD · Principal investigator
    • Sory Conde, MD, MPH · Principal investigator
    • Mahamoud Sama Cherif, MD, PhD · Principal investigator
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided — Individual participant data (IPD) will be shared under reasonable request

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Feb 2027, 10 months later.

Of 23 observational studies under Mpox, Monkeypox, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 10 months is below that.

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

Registered
Apr 10, 2026
First posted
Apr 16, 2026
StartEst.
Apr 16, 2026
Primary completionEst.
Feb 28, 2027
CompletionEst.
Aug 2027
Last update
Apr 16, 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 Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07534267
Collaborators
University of Glasgow, Centre National de Formation et de Recherche en Sante Rurale, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia, Agence Nationale de Sécurité Sanitaire de Guinée (ANSS), Institut National de la Santé Publique de Guinée (INSP)
Responsible party
Edward Choi (Assistant Professor, London School of Hygiene and Tropical Medicine) — Principal investigator
First posted
Apr 16, 2026
Start date
Apr 16, 2026 (estimated)
Primary completion
Feb 28, 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Apr 16, 2026

Study contacts

Edward M Choi, PhD
Contact
edward.choi@lshtm.ac.uk
+44 20 7636 8636
Deborah Watson-Jones, PhD
Contact
deborah.watson-jones@lshtm.ac.uk
+44 20 7636 8636
Edward M Choi, PhD
principal investigator · London School of Hygiene and Tropical Medicine
Michael E Marks, PhD
study chair · London School of Hygiene and Tropical Medicine
Oriol Mitjà, PhD
study chair · Fundación FLS de lucha contra el sida las enfermedades infecciosas y la promoción de la salud y la ciencia, Spain
Deborah Watson-Jones, PhD
principal investigator · London School of Hygiene and Tropical Medicine

Oversight

Data monitoring committee
No
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 Apr 2026. You cannot join it, but the record below documents what was studied.

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