Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts

NCT07267390 | Completed

• 1 other identifier: MOVIE-TRACE
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mpox (Monkeypox)

Keywords

viral clearance; secondary attack rate; DRC

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Epidemiological, clinical, and exposure-related factors associated with mpox transmission

  From day 1 to day 14

Study Arms (2)

MOVIE

Mpox confirmed case

TRACE

Contact of a MOVIE case

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead
• University of Kinshasa: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Univeristy of Kinshasa

Kinshasa, Democratic Republic of the Congo

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, lesion swap, oropharyngeal swab

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Oriol Mitjà, Professor

  Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Infectious Diseases and Global Health

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 5, 2025
• Study Start: October 31, 2025
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-02

Locations

DE (1)