Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts (MOVIE-TRACE)

MOVIE-TRACE Study: Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts

The MOVIE-TRACE project includes two complementary observational studies designed to improve the understanding of Mpox virus infection and its transmission within affected communities. The MOVIE study aims to describe the dynamics of viral clearance in patients with confirmed Mpox. It measures how the viral load changes over time in different biological samples to inform decisions about patient management and isolation guidelines. The TRACE study focuses on understanding how mpox spreads from confirmed cases to their contacts. It will estimate the Secondary Attack Rate (SAR) and identify factors associated with transmission risk. The results will help guide public health strategies for contact tracing, vaccination, and outbreak control.

Study Overview

• Status: Completed
• Conditions: Mpox (Monkeypox)

Detailed Description

Starting in late 2023, an increasing number of confirmed cases of Mpox caused by clade I Mpox virus (MPXV) were reported across several provinces of the Democratic Republic of the Congo (DRC). In August 2024, the World Health Organization (WHO) declared the ongoing outbreak a Public Health Emergency of International Concern due to its expanding geographic spread and significant public health impact.

Mpox is transmitted through direct contact with skin or mucosal lesions of infected individuals, contaminated materials. MPXV can be detected in multiple biological samples, including skin lesion swabs, blood, throat swabs, and occasionally urine. However, there is still limited information on how long and in which compartments the virus can persist, as well as on how efficiently it spreads between individuals during community outbreaks caused by clade I virus.

The MOVIE-TRACE project includes two complementary observational studies designed to address these critical gaps in knowledge and to strengthen the understanding of clade I MPXV infection in the DRC.

The MOVIE study aims to describe how MPXV is cleared from the body over time among patients with PCR-confirmed Mpox infection. Despite the importance of isolation and infection control in outbreak management, there is limited evidence on how long individuals remain infectious. MOVIE addresses this critical gap by conducting longitudinal follow-up of Mpox-positive patients for up to two months, with several scheduled visits during which multiple biological specimens are collected. These samples will be analyzed to assess viral persistence in different body compartments and to characterize the kinetics of viral clearance. The findings will help refine isolation duration, improve clinical management, and guide infection prevention policies.

The TRACE study seeks to understand how Mpox spreads from confirmed cases to their contacts. By systematically collecting exposure data and testing contacts for infection, TRACE will estimate the Secondary Attack Rate (SAR) and identify factors that increase the likelihood of transmission. This information will support public health measures such as contact tracing, quarantine strategies, and targeted vaccination in endemic regions.

Together, MOVIE and TRACE will generate essential evidence on both viral clearance and transmission of clade I MPXV, providing a comprehensive understanding of the infection and informing data-driven outbreak response strategies in the Democratic Republic of the Congo.

• Study Type: Observational
• Enrollment (Actual): 550

Contacts and Locations

Study Locations

• Democratic Republic of the Congo
  • Kinshasa, Democratic Republic of the Congo
    • Univeristy of Kinshasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All individuals with confirmed Mpox infection, regardless of age or sex.

Description

Inclusion Criteria:

• MOVIE Study:

  • Individuals of any sex and age presenting with lesions clinically suggestive of Mpox, as assessed by a trained health worker.
  • 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 years or older.
  • For participants who cannot read or write, witnessed consent will be obtained.

• TRACE Study:

  • Individuals who have had close physical contact with a polymerase chain reaction (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.

Exclusion Criteria:

• MOVIE Study:

  • Cases of severe Mpox requiring hospitalization.
  • Individuals with a confirmed alternative diagnosis explaining their illness.
  • Prior vaccination against Mpox.
  • Individuals over 40 years of age who report having received smallpox vaccination during infancy.

• TRACE Study:

  • Prior vaccination against Mpox.
  • Individuals over 40 years of age who report having received smallpox vaccination during infancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
MOVIE; Mpox confirmed case
TRACE; Contact of a MOVIE case

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to undetectable MPXV DNA in skin lesion swabs measured by quantitative PCR	Time from enrollment to the first skin lesion swab with undetectable MPXV DNA, defined as cycle threshold (Ct) >35 by quantitative polymerase chain reaction (qPCR).	From day 1 to day 56
Time to undetectable MPXV DNA in oropharyngeal swabs measured by quantitative PCR	Time from enrollment to the first oropharyngeal swab with undetectable MPXV DNA, defined as Ct >35 by qPCR.	From day 1 to day 56
Time to undetectable MPXV DNA in blood measured by quantitative PCR	Time from enrollment to the first blood sample with undetectable MPXV DNA, defined as Ct >35 by qPCR.	From day 1 to day 56
Secondary attack rate of mpox among contacts of index cases	Secondary attack rate (SAR), defined as the proportion of contacts of laboratory-confirmed mpox cases who develop laboratory-confirmed mpox during follow-up, assessed through clinical evaluation and MPXV qPCR testing.	From day 1 to day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidemiological, clinical, and exposure-related factors associated with mpox transmission	Transmission-related factors will be assessed using standardized epidemiological questionnaires and clinical case report forms administered to index cases and contacts at baseline and follow-up. Variables assessed will include type and frequency of contact, exposure to skin lesions or bodily fluids, sleeping arrangements, sexual contact, household characteristics, symptoms, lesion burden, and MPXV DNA results by qPCR. Associations with transmission will be evaluated by comparing characteristics of transmitting versus non-transmitting index cases and infected versus non-infected contacts.	From day 1 to day 14

Collaborators and Investigators

• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Collaborators: London School of Hygiene and Tropical Medicine; University of Kinshasa
• Investigators: Principal Investigator: Oriol Mitjà, Professor, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2025
• Primary Completion (Actual): February 27, 2026
• Study Completion (Actual): February 27, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: DRC; viral clearance; secondary attack rate
• Additional Relevant MeSH Terms: Infections; Virus Diseases; Poxviridae Infections; DNA Virus Infections; Animal Diseases; Primate Diseases; Rodent Diseases; Mpox, Monkeypox
• Other Study ID Numbers: MOVIE-TRACE

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