Understanding MPXV Viral Clearance, Transmission Dynamics, and Mpox Vaccine Effectiveness in West Africa : Guinea (MOVIE-TRACE-WA)

April 10, 2026 updated by: Edward Choi, London School of Hygiene and Tropical Medicine

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

992

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Guinea
      • Conakry, Guinea
        • Centre National de Formation et de Recherche en Sante Rurale de Maferinyah
        • Contact:
        • Principal Investigator:
          • Abdoul H Beavogui, MD, PhD
        • Principal Investigator:
          • Sory Conde, MD, MPH
        • Principal Investigator:
          • Mahamoud Sama Cherif, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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 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.

  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:

(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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MOVIE
Confirmed Mpox cases
TRACE
Contacts of a MOVIE case
VE
Confirmed Mpox cases and their contacts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral clearance in oropharyngeal swabs
Time Frame: From day 1 to day 56
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
Time Frame: From day 1 to day 14
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
Time Frame: From day 1 to day 28
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral clearance in skin lesions
Time Frame: From day 1 to day 56
Time to viral clearance in skin lesions (number of days from onset of symptoms to first negative PCR result).
From day 1 to day 56
Viral clearance in urine
Time Frame: From day 1 to day 56
Time to viral clearance in urine (number of days from onset of symptoms to first negative PCR result).
From day 1 to day 56
Risk factors of transmission
Time Frame: From day 1 to day 14
Identification of factors that influence the risk of transmission
From day 1 to day 14
Immunological assessments
Time Frame: From day 1 to day 56
Measurement of MPXV-specific antibodies by immunoassays
From day 1 to day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
University of Glasgow
Centre National de Formation et de Recherche en Sante Rurale
Agence Nationale de Sécurité Sanitaire de Guinée (ANSS)
Institut National de la Santé Publique de Guinée (INSP)

Investigators

  • Principal Investigator: Deborah Watson-Jones, PhD, London School of Hygiene and Tropical Medicine
  • Principal Investigator: Edward M Choi, PhD, London School of Hygiene and Tropical Medicine
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 16, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOVIE-TRACE-West Africa
  • UKRI2532 (Other Grant/Funding Number: Medical Research Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) will be shared under reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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