MpoxREMAINNCT05522296
Break-through Infection Following Mpox vaccinatIon
An observational study of Mpox, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 6 sites in 4 countries.
Trial summary
The purpose of this study is to assess the protection of smallpox preexposure vaccination against infection with mpox in real-world individuals with risk factors for mpox. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mpox
- What is being tested?
- Mpox Vaccine
- Type of treatment
- Vaccines
- How many people
- 3,125 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 12 Sep 2022to 30 Mar 2024
- How long will I take part?
- 18 Months
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Vaccinated and unvaccinated individuals who have risk factors for mpox infection and do not have a past history of mpox infection.
Who may be able to join
- Individuals aged 18 years or older.
- Individuals with general risk factors for mpox infection, as currently defined by the local guidelines for vaccination. These risk factors include at least one of the following items:
- Individual-reported use of HIV pre-exposure prophylaxis (PrEP).
- Individual-reported chemsex practices
- Individual-reported multiple sexual partners.
- Individuals with a history of a sexually transmitted infection (STI) in the past year.
- Individuals living with HIV infection.
- Signature of informed consent.
Who cannot join
- Unable to provide signature of informed consent.
- Past infection with monkeypox.
- Past smallpox vaccination.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Peru3 sites
Hospital Regional III Honorio Delgado
Arequipa
Hospital Nacional Arzobispo Loayza
Lima, 15082
Hospital Regional Docente de Trujillo
Trujillo, 13011
Chile1 site
Hospital Clínico San Borja Arriarán
Santiago, Santiago Metropolitan, 8360154
Panama1 site
Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES)
Panama City
About this study
Official title: Break-through Infection Following Mpox vaccinatIon: Target Trial Emulation
The purpose of this study is to assess the protection of smallpox preexposure vaccination against infection with mpox in real-world individuals with risk factors for mpox.
Read the detailed description
A Target Trial Emulation study that tries to emulate the sequential specification of a target trial will be conducted measuring and controlling confounders when there is a common cause of vaccination and outcome event.
Participants will be provided with a Quick response (QR) code to access the RedCap study platform, which will guide them to the enrolment process. If the participant accepts and meets all the inclusion and none of the exclusion criteria, they will be directed to a baseline survey to self-collect sociodemographic data and information regarding risk factors, sexual behaviour, vaccination, and exposure to mpox.
Newly vaccinated participants will be matched 1:1 to unvaccinated controls. The matching will be performed based on the site of recruitment, and self-reported baseline sexual health and practices. Vaccinated and unvaccinated participants will be matched on variables associated with the probability of infection.
Follow-up will include regular surveys every month from the index date (i.e., enrolment date in the unvaccinated group, or vaccination date for the vaccinated group), to collect data on change on risk factors, sexual behaviour in the past month, vaccination status, and exposure to mpox. The participant will be asked to self-report if they develop symptoms suggestive of mpox, and the study platform will direct them to a specific mpox infection survey.
For each participant, follow-up will end at the earliest of the following events: mpox infection, voluntary withdraw, or the end of the study period. A health record review will be conducted to corroborate the diagnosis of new cases and to provide validity to the self-report.
- Conditions
- Mpox
- Being tested
- Mpox Vaccine
- Keywords
- Monkeypox, Mpox Vaccine, Intradermal Mpox vaccine, Mpox
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mpox VaccineDrug
Vaccination with smallpox and mpox vaccine (Live Modified Vaccinia Virus Ankara)
| Study group | Role | What they receive |
|---|---|---|
| Unvaccinated | Unvaccinated individuals who have risk factors for mpox infection and do not have a past history of mpox infection | |
| Vaccinated | Vaccinated individuals with smallpox and mpox vaccine (Live Modified Vaccinia Virus Ankara) who have risk factors for monkeypox infection and do not have a past history of mpox infection. Receives: Drug: Mpox Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymerase chain reaction (PCR)-confirmed mpox infection
Mpox PCR positivity in participants with mpox infection symptoms
Measured: From 14 days after the index date to twelve months after the index date
Secondary outcomes (8)
Polymerase chain reaction (PCR)-confirmed mpox infection
Mpox PCR positivity in participants with mpox infection symptoms
Measured: From immediately after the index date to twelve months after the index date
Duration of general symptoms
Time from onset to resolution of general symptoms in participants with PCR-confirmed mpox infection (in days).
Measured: From 14 days after the index date to twelve months after the index date
Severity of rash
Number of mpox lesions (lesions count)
Measured: From 14 days after the index date to twelve months after the index date
Duration of skin rash
Time from onset to resolution of skin rash in participants with PCR-confirmed
Measured: From 14 days after the index date to twelve months after the index date
Medical treatment
Requirement of medical treatment (yes/no)
Measured: From 14 days after the index date to twelve months after the index date
Hospitalization
Requirement of hospital admission (yes/no)
Measured: From 14 days after the index date to twelve months after the index date
Scarring
Residual scarring after mpox (yes/no)
Measured: From 14 days after the index date to twelve months after the index date
Safety and tolerability
Description of systemic and skin reactions
Measured: One month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start12 Sep 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MpoxStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,125 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya, Hospital Vall d'Hebron, Hospital Clinic of Barcelona, Hospital Universitario 12 de Octubre, Public Health Service of Madrid, Madrid Salud, Harvard School of Public Health (HSPH), London School of Hygiene and Tropical Medicine, Germans Trias i Pujol Hospital, BCN Checkpoint, Centro de Saluld Sandoval, Centro de Salud Montesa, Hospital Nacional Arzobispo Loayza, Hospital Regional III Honorio Delgado, Hospital Regional Docente de Trujillo, Instituto Conmemorativo Gorgas de Estudios de la Salud, Ministerio de Salud de Panamá, Fundación Arriaran
- Responsible party
- Principal investigator, Oriol Mitja, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522296
- Sponsor's protocol ID
- REMAIN
- Acronym
- REMAIN
- Status last verified
- Jun 2024
- First submitted
- 27 Aug 2022
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request after publication
Publications
Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, Hernan MA, Lipsitch M, Kohane I, Netzer D, Reis BY, Balicer RD. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2021 Sep 16;385(12):1078-1090. doi: 10.1056/NEJMoa2110475. Epub 2021 Aug 25.
PubMed 34432976
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Break-through Infection Following Mpox vaccinatIon: Target Trial Emulation
- ClinicalTrials.gov ID
- NCT05522296
- Acronym / sponsor ID
- REMAIN / REMAIN
- Conditions
- Mpox
- Keywords
- Monkeypox, Mpox Vaccine, Intradermal Mpox vaccine, Mpox
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,125 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya, Hospital Vall d'Hebron, Hospital Clinic of Barcelona, Hospital Universitario 12 de Octubre, Public Health Service of Madrid, Madrid Salud, Harvard School of Public Health (HSPH), London School of Hygiene and Tropical Medicine, Germans Trias i Pujol Hospital, BCN Checkpoint, Centro de Saluld Sandoval, Centro de Salud Montesa, Hospital Nacional Arzobispo Loayza, Hospital Regional III Honorio Delgado, Hospital Regional Docente de Trujillo, Instituto Conmemorativo Gorgas de Estudios de la Salud, Ministerio de Salud de Panamá, Fundación Arriaran
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 31 Aug 2022 (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.
The purpose of this study is to assess the protection of smallpox preexposure vaccination against infection with mpox in real-world individuals with risk factors for mpox.
Detailed description
A Target Trial Emulation study that tries to emulate the sequential specification of a target trial will be conducted measuring and controlling confounders when there is a common cause of vaccination and outcome event.
Participants will be provided with a Quick response (QR) code to access the RedCap study platform, which will guide them to the enrolment process. If the participant accepts and meets all the inclusion and none of the exclusion criteria, they will be directed to a baseline survey to self-collect sociodemographic data and information regarding risk factors, sexual behaviour, vaccination, and exposure to mpox.
Newly vaccinated participants will be matched 1:1 to unvaccinated controls. The matching will be performed based on the site of recruitment, and self-reported baseline sexual health and practices. Vaccinated and unvaccinated participants will be matched on variables associated with the probability of infection.
Follow-up will include regular surveys every month from the index date (i.e., enrolment date in the unvaccinated group, or vaccination date for the vaccinated group), to collect data on change on risk factors, sexual behaviour in the past month, vaccination status, and exposure to mpox. The participant will be asked to self-report if they develop symptoms suggestive of mpox, and the study platform will direct them to a specific mpox infection survey.
For each participant, follow-up will end at the earliest of the following events: mpox infection, voluntary withdraw, or the end of the study period. A health record review will be conducted to corroborate the diagnosis of new cases and to provide validity to the self-report.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unvaccinated | – | –Unvaccinated individuals who have risk factors for mpox infection and do not have a past history of mpox infection |
| Vaccinated | – | Drug: Mpox VaccineVaccinated individuals with smallpox and mpox vaccine (Live Modified Vaccinia Virus Ankara) who have risk factors for monkeypox infection and do not have a past history of mpox infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vaccinated and unvaccinated individuals who have risk factors for mpox infection and do not have a past history of mpox infection.
Key inclusion criteria (8 listed)
- Individuals aged 18 years or older.
- Individuals with general risk factors for mpox infection, as currently defined by the local guidelines for vaccination. These risk factors include at least one of the following items:
- Signature of informed consent.
Key exclusion criteria (3 listed)
- Unable to provide signature of informed consent.
- Past infection with monkeypox.
- Past smallpox vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mpox VaccineVaccination with smallpox and mpox vaccine (Live Modified Vaccinia Virus Ankara) | Drug | Vaccinated |
Primary outcome
Polymerase chain reaction (PCR)-confirmed mpox infection
Time frame: From 14 days after the index date to twelve months after the index date
Mpox PCR positivity in participants with mpox infection symptoms
8 secondary outcomes
Polymerase chain reaction (PCR)-confirmed mpox infection
Time frame: From immediately after the index date to twelve months after the index date
Duration of general symptoms
Time frame: From 14 days after the index date to twelve months after the index date
Severity of rash
Time frame: From 14 days after the index date to twelve months after the index date
Duration of skin rash
Time frame: From 14 days after the index date to twelve months after the index date
Medical treatment
Time frame: From 14 days after the index date to twelve months after the index date
Hospitalization
Time frame: From 14 days after the index date to twelve months after the index date
Scarring
Time frame: From 14 days after the index date to twelve months after the index date
Safety and tolerability
Time frame: One month after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Background: PubMed 34432976Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, Hernan MA, Lipsitch M, Kohane I, Netzer D, Reis BY, Balicer RD. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2021 Sep 16;385(12):1078-1090. doi: 10.1056/NEJMoa2110475. Epub 2021 Aug 25.
- Recommendations of experts in trial design to World Health OrganizationLink provided by the sponsor.
- Spanish incidence estimation document for the calculation of the number of participantsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon request after publication
Related trials for Mpox
RecruitingObservational study
Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)
Mpox (Monkeypox), Mpox
Enrolling by invitationObservational study
New York City Observational Study of Mpox Immunity
Monkeypox, Mpox
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Active, not recruitingPhase 4
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Monkeypox
RecruitingPhase 2
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
Mpox (Monkeypox), Smallpox
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mpox, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 6 sites in 4 countries.
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Peru, Chile, Panama, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polymerase chain reaction (PCR)-confirmed mpox infection (time frame: From 14 days after the index date to twelve months after the index date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05522296, which also lists 1 linked publication.
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 6 Jun 2024.