Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS (MPX-Assess)

September 28, 2023 updated by: Institute of Tropical Medicine, Belgium
Monkeypox (MPX) is a viral zoonosis, caused by the Monkeypox virus (MPXV), a DNA virus that belongs to the Orthopoxvirus genus and is closely related to the variola virus, the causative agent of smallpox. Until recently the spread of MPX was mainly confined to the Central African rainforest and to parts of West Africa. However, in May 2022, several cases of MPX were detected throughout Europe and Northern America, albeit with a different presentation than previously seen. Many questions remain on this new presentation of the disease: what the exact mode of transmission is, how contagious the virus really is and whether asymptomatic carriers exist. With this study the researchers aim to perform a close follow-up study of close contacts of MPX confirmed cases. Participants are recruited among high and very high risk contacts of confirmed monkeypox patients that presented to the ITM for diagnosis (index). Contacts that are asymptomatic (for symptoms compatible with MPXV infection according to national case definitions) at the time of recruitment will be enrolled. Contacts of the index case that are symptomatic at recruitment or become symptomatic during follow-up will be invited for sample collection at different timepoints until 21 days after contact as suspect cases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2000
        • Institute of Tropical Medicine Antwerp

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants are recruited among high and very high risk contacts of confirmed monkeypox patients that presented to the ITM for diagnosis (index). Contacts that are asymptomatic (for symptoms compatible with MPXV infection according to national case definitions) at the time of recruitment will be enrolled.

Description

Inclusion Criteria:

  1. Be a high risk or very high-risk contact of a laboratory confirmed monkeypox case, with:

    • Very high-risk contact:

      • Sexual partner(s)
      • Prolonged skin-to-skin contact while the patient had skin lesions

    • High risk contact

      • living in the same household or similar environment (e.g. camping, spending the night, etc.);
      • shared clothing, bedding, utensils, etc., while the patient had skin lesions
      • healthcare workers with unprotected contact (inadequate or no PPE)
  2. Last exposure to the monkeypox index case of less than 21 days ago
  3. Adult participants (≥ 18 years old) of any gender
  4. Written informed consent is obtained from the participant

Exclusion Criteria:

  1. Presenting with symptoms compatible with MPX:

    • an unexplained rash on any part of the body AND
    • one or more of the following symptoms: fever, headache, back pain, fatigue, lymphadenopathy (localised or generalised)
  2. Inability or unwillingness to comply with the proposed follow-up schedule

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
MPX-Assess
Contacts of MPX index cases

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample
Time Frame: Until 21 days after contact with index case
Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample
Until 21 days after contact with index case

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of seroconversion in contacts, defined as a positive IgG (immunoglobulineG) for monkeypox
Time Frame: Until 21 days after contact with index case
To evaluate the rate of seroconversion in contacts (positive IgG for MPX) within 21 days after contact with index case
Until 21 days after contact with index case
Proportion of seroconversion in PCR positive contacts vs PCR negative contacts, defined as negative MPXV PCR in all samples until the end of the follow-up period
Time Frame: Until 21 days after contact with index case
Proportion of seroconversion in PCR positive contacts vs PCR negative contacts, defined as negative MPXV PCR in all samples until the end of the follow-up period
Until 21 days after contact with index case
Time to seroconversion overall, in symptomatic and asymptomatic contacts, and in PCR positive and negative cases
Time Frame: Until 21 days after contact with index case
Time to seroconversion overall, in symptomatic and asymptomatic contacts, and in PCR positive and negative cases
Until 21 days after contact with index case
Proportion of PCR positive participants with asymptomatic infection at time of first positive PCR
Time Frame: Until 21 days after contact with index case
Proportion of PCR positive participants with asymptomatic infection at time of first positive PCR
Until 21 days after contact with index case
Proportion of PCR positive participants developing symptoms within the follow-up period
Time Frame: Until 21 days after contact with index case
Proportion of PCR positive participants developing symptoms within the follow-up period
Until 21 days after contact with index case
Proportion of asymptomatic infections on number of contacts in follow-up. Asymptomatic infections are defined as contacts with positive MPXV PCR on any clinical sample, without development of any symptoms.
Time Frame: within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer
Proportion of asymptomatic infections on number of contacts in follow-up. Asymptomatic infections are defined as contacts with positive MPXV PCR on any clinical sample, without development of any symptoms within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer
within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer
Time from MPXV PCR positivity in any sample to appearance of any symptom overall and per mode of transmission (close personal contact; anal, vaginal or oral receptive sexual contact; and insertive sexual contact)
Time Frame: at the end of the 3-week follow-up period
Time from MPXV PCR positivity in any sample to appearance of any symptom overall and per mode of transmission (close personal contact; anal, vaginal or oral receptive sexual contact; and insertive sexual contact)
at the end of the 3-week follow-up period
Time from MPXV PCR positivity in any sample to appearance of skin lesions
Time Frame: at the end of the 3-week follow-up period
Time from MPXV PCR positivity in any sample to appearance of skin lesions
at the end of the 3-week follow-up period
Time from confirmed exposure to first PCR positivity
Time Frame: at the end of the 3-week follow-up period
Time from confirmed exposure to first PCR positivity
at the end of the 3-week follow-up period
Time from confirmed exposure to appearance of any symptom
Time Frame: at the end of the 3-week follow-up period
Time from confirmed exposure to appearance of any symptom
at the end of the 3-week follow-up period
Time from confirmed exposure to appearance of skin lesions
Time Frame: at the end of the 3-week follow-up period
Time from confirmed exposure to appearance of skin lesions
at the end of the 3-week follow-up period
Description of the type of symptoms observed in monkeypox contacts
Time Frame: within 3 weeks after last exposure
Description of the type of symptoms observed in monkeypox contacts within 3 weeks after last exposure
within 3 weeks after last exposure
Frequency of symptoms observed in monkeypox contacts
Time Frame: within 3 weeks after last exposure
Frequency of symptoms observed in monkeypox contacts within 3 weeks after last exposure
within 3 weeks after last exposure
Timing of symptoms observed in monkeypox contacts
Time Frame: within 3 weeks after last exposure
Timing of symptoms observed in monkeypox contacts within 3 weeks after last exposure
within 3 weeks after last exposure
Distribution of skin lesions for sexual contacts versus close personal contacts. (per body surface and per category: local vs generalized skin lesions)
Time Frame: at the end of the 3-week follow-up period
Distribution of skin lesions for sexual contacts versus close personal contacts. (per body surface and per category: local vs generalized skin lesions)
at the end of the 3-week follow-up period
Proportion of contacts presenting with systemic symptoms after sexual exposure versus those with close personal contacts exposure
Time Frame: at the end of the 3-week follow-up period
Proportion of contacts presenting with systemic symptoms after sexual exposure versus those with close personal contacts exposure
at the end of the 3-week follow-up period
Number of contacts with the defined risk and protective factors
Time Frame: At baseline
Number of contacts with the defined risk and protective factors
At baseline
Proportion of presence of defined factors in PCR positive contacts.
Time Frame: Until the end of the 3-week follow-up period
Proportion of presence of defined factors in PCR positive contacts.
Until the end of the 3-week follow-up period
Proportion of presence of defined factors in symptomatic PCR positive contacts
Time Frame: Until the end of the 3-week follow-up period
Proportion of presence of defined factors in symptomatic PCR positive contacts
Until the end of the 3-week follow-up period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Presence of culturable virus in PCR positive samples from pre- or asymptomatic period
Time Frame: Until the end of the 3-week follow-up period
Presence of culturable virus in PCR positive samples from pre- or asymptomatic period
Until the end of the 3-week follow-up period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Tropical Medicine, Belgium

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurens Liesenborghs, MD, Instituut van Tropische Geneeskunde Antwerpen

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MPX-Assess

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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