Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05879965
Status:
RECRUITING
Last Update Posted:
2023-05-30
First Post:
2023-05-19
Brief Title:
Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk
Sponsor:
Institute of Tropical Medicine Belgium
Organization:
Institute of Tropical Medicine Belgium
Study Overview
Official Title:
Prospective On-site and Questionnaire Study for the FOLLOW-UP of Mpox Cohort at ITM PLUS Evaluation of the Longevity of B- and T-cell Immune Responses in Former Mpox Patients and Vaccine Recipients
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POQS-FU PLUS
Brief Summary:
The goal of this observational study is to describe possible physical and psychological sequelae after an mpox infection and to evaluate the longevity of B- and T-cell immune responses in former mpox patients and vaccine recipients
The main questions it aims to answer are
Are there any physical or pschological sequelae after mpox infection
Is the humoral andor cellular immune response to MPOX or vaccinia virus durable
Do the patients develop strong local immunity in comparison to systemic immunity
How long is the virus still detectable in semen saliva or the ano-rectal region
Participants will answer a questionnaire samples with blood saliva and semen as well as anal swabs will be collected Follow-up visits 8 16 and 24 months after infection or vaccination are planned
A healthy control group will be recruited in our HIV-PrEP clinic
The main questions it aims to answer are
Are there any physical or pschological sequelae after mpox infection
Is the humoral andor cellular immune response to MPOX or vaccinia virus durable
Do the patients develop strong local immunity in comparison to systemic immunity
How long is the virus still detectable in semen saliva or the ano-rectal region
Participants will answer a questionnaire samples with blood saliva and semen as well as anal swabs will be collected Follow-up visits 8 16 and 24 months after infection or vaccination are planned
A healthy control group will be recruited in our HIV-PrEP clinic
Detailed Description:
Long-term problems or sequelae after an acute viral infection are described The study aim is to investigate if long-term symptoms and sequelae can be found in the ITM human mpox infection cohort previously diagnosed and confirmed by PCR at the Institute of Tropical Medicine in Antwerp during the mpox outbreak 2022 in Belgium The immune response after a natural mpox infection and after a smallpox vaccination will additionally analysed over time
Consented participants Mpox patients acute infection n169 21 assumed smallpox vaccination in childhood Mpox patients for follow-up n95 20 assumed smallpox vaccination in childhood Smallpox vaccinees two intradermal doses n100 Smallpox vaccinees two subcutaneous doses n100 Healthy unvaccinated controls n50
Design This prospective longitudinal study has the main objectives to describe possible physical and psychological sequelae after an mpox infection and to evaluate the longevity of B- and T-cell immune responses in former mpox patients and vaccine recipients Participants are being followed up 8 16 and 24 months after infection or vaccination
Sample collection Anal eSwabs from patients controls and vaccinees Saliva Omnigene-oral and dry swabs from patients controls and vaccinees Serum from patients controls and vaccinees Optional semen samples from patients PBMC samples from a sub-group of patients controls and vaccinees
Laboratory analysis MPXV-PCR on saliva anorectal and optional semen samples of former mpox patients vaccinated individuals and healthy controls Mpox-specific antibody profiling from serum Mucosal immunity IgA IgG mpox-specificreactive from anal swabs andor saliva Enumeration of MPXV-specific effector-memory T cells via flow cytometry-based AIM or ICS assays peptide pool stimulation or HLA-restricted multimer-based capture assays Enumeration of MPXV-specific memory B cells or plasma cells via flow cytometry-ased AIM or ICS assays recombinant antigen stimulation or HLA-restricted multimer-based capture assays
Consented participants Mpox patients acute infection n169 21 assumed smallpox vaccination in childhood Mpox patients for follow-up n95 20 assumed smallpox vaccination in childhood Smallpox vaccinees two intradermal doses n100 Smallpox vaccinees two subcutaneous doses n100 Healthy unvaccinated controls n50
Design This prospective longitudinal study has the main objectives to describe possible physical and psychological sequelae after an mpox infection and to evaluate the longevity of B- and T-cell immune responses in former mpox patients and vaccine recipients Participants are being followed up 8 16 and 24 months after infection or vaccination
Sample collection Anal eSwabs from patients controls and vaccinees Saliva Omnigene-oral and dry swabs from patients controls and vaccinees Serum from patients controls and vaccinees Optional semen samples from patients PBMC samples from a sub-group of patients controls and vaccinees
Laboratory analysis MPXV-PCR on saliva anorectal and optional semen samples of former mpox patients vaccinated individuals and healthy controls Mpox-specific antibody profiling from serum Mucosal immunity IgA IgG mpox-specificreactive from anal swabs andor saliva Enumeration of MPXV-specific effector-memory T cells via flow cytometry-based AIM or ICS assays peptide pool stimulation or HLA-restricted multimer-based capture assays Enumeration of MPXV-specific memory B cells or plasma cells via flow cytometry-ased AIM or ICS assays recombinant antigen stimulation or HLA-restricted multimer-based capture assays
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None