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

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

Overview

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.

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.

Primary outcome measures

• Viral clearance in oropharyngeal swabs [Time frame: From day 1 to day 56]
• Secondary attack rate of infection [Time frame: From day 1 to day 14]
• Secondary attack rate of disease [Time frame: From day 1 to day 28]

Secondary outcome measures (4)

• Viral clearance in skin lesions [Time frame: From day 1 to day 56]
• Viral clearance in urine [Time frame: From day 1 to day 56]
• Risk factors of transmission [Time frame: From day 1 to day 14]
• Immunological assessments [Time frame: From day 1 to day 56]

Eligibility criteria

Inclusion criteria

• 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.
• 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Guinea · 1 center

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

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, Garc PMID 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, P PMID 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. PMID 36403582

Identifiers

NCT: NCT07534267 · MOVIE-TRACE-West Africa · UKRI2532

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗