Mpox (Monkeypox)LAMPNCT06353737
Looking for Asymptomatic Mpox in a Population at High Risk
An observational study of Mpox (Monkeypox), run by Unity Health Toronto at 1 site in Canada.
Trial summary
Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Mpox (Monkeypox)
- How many people
- 450 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants need to have been enrolled in an existing randomized clinical trial (NCT04762134)
Who may be able to join
- Participants need to have been enrolled in an existing randomized clinical trial (NCT04762134)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Unity Health Toronto
Toronto, Ontario, M5B 1T8
Reva Persaud, 416-360-4000 ext. 77105, reva.persaud@unityhealth.to
Darrell HS Tan
About this study
Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature.
- Conditions
- Mpox (Monkeypox)
- Medical subject headings
- Mpox, Monkeypox
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymptomatic prevalence
To determine the prevalence of asymptomatic, pre-symptomatic and paucisymptomatic mpox infection (pooled and individually), in a population of GBMSM with anticipated high mpox risk and high prevalence of vaccination.
Measured: 2 weeks
Secondary outcomes (4)
Symptomatic prevalence
To determine the prevalence of symptomatic mpox infection in the study sample
Measured: 2 weeks
Mpox seropositivity
To determine the prevalence of mpox seropositivity (both for total antibody and for neutralizing antibody) in the study sample
Measured: 2 weeks
Characteristics
To identify clinical and demographic characteristics associated with asymptomatic and/or paucisymptomatic infection in the study sample
Measured: 2 weeks
Characteristics of seropositivity
To identify clinical and demographic characteristics associated with mpox seropositivity in the study sample
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Apr 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mpox (Monkeypox)Studies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353737
- Sponsor's protocol ID
- CTO 4489
- Acronym
- LAMP
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Group level data will be made available upon request
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Looking for Asymptomatic Mpox in a Population at High Risk
- ClinicalTrials.gov ID
- NCT06353737
- Acronym / sponsor ID
- LAMP / CTO 4489
- Conditions
- Mpox (Monkeypox)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants need to have been enrolled in an existing randomized clinical trial (NCT04762134)
Key inclusion criteria (1 listed)
- Participants need to have been enrolled in an existing randomized clinical trial (NCT04762134)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asymptomatic prevalence
Time frame: 2 weeks
To determine the prevalence of asymptomatic, pre-symptomatic and paucisymptomatic mpox infection (pooled and individually), in a population of GBMSM with anticipated high mpox risk and high prevalence of vaccination.
4 secondary outcomes
Symptomatic prevalence
Time frame: 2 weeks
Mpox seropositivity
Time frame: 2 weeks
Characteristics
Time frame: 2 weeks
Characteristics of seropositivity
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No. Group level data will be made available upon request
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New York City Observational Study of Mpox Immunity
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Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
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A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mpox (Monkeypox), run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abby Li, MSc (416-360-4000 ext. 77426, abby.li@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymptomatic prevalence (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.