Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-31 @ 6:50 PM
Study NCT ID:
NCT06887556
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks
Sponsor:
University of Birmingham
Organization:
Study Overview
Official Title:
Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks
Status:
RECRUITING
Status Verified Date:
2024-11
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:
MPOX CARE
Brief Summary:
The MPXV CARE study principally aims to use clinical and epidemiology data to target specific individuals willing and able to provide appropriate and proportionate biological samples to develop novel immune diagnostics that support models of disease burden and future vaccine utilisation.
Detailed Description:
Cases of Mpox in Central and East Africa have been climbing since December 2022 when Democratic Republic of Congo (DRC) declared a national outbreak of the disease. There are two strains of circulating virus, clade Ia (previously known as clade I) in northwestern DRC primarily affecting children, and a new strain clade Ib in northeastern DRC which has since spread to bordering countries. The clade Ib strain, sub-lineage A was first identified in South Kivu. This strain has been found to have a APOBEC3-type mutations allowing increased circulation between humans. This novel clade is mainly characterized by the gene insertions and deletions including the deletion on C3L gene that effect the CDC recommended Clade I-specific real-time PCR detection. The WHO Director General declared the outbreak a public health emergency on 14th August 202433 as a result of escalating case numbers of both clade I strains. As of 28July 2024, this year there have been a total of 14,250 cases in 10 African countries, with a case fatality of 3.2%. This is likely to be an underestimate given the limited testing and healthcare capacity in some of the regions affected. The clade 1b Mpox outbreak is an urgent public health emergency in need of scientific countermeasures to control the spread of disease and protect African communities.
The primary clinical aim of this study to develop novel immune diagnostics to estimate Mpox's sero-prevalence and determine exposure to Mpox virus and/or previous vaccination as a tool for vaccine prioritization among at risk populations.
Participants will be recruited from the following groups:
* Group 1 (suspected exposure cohort): asymptomatic volunteers at risk of Mpox including:
* Those who live within or adjacent to, or spend prolonged amounts of time in an epidemiologically identified region of Mpox transmission
* Close contacts of those with microbiologically confirmed Mpox
* Group 2 (post-exposure/vaccinated cohort):
* asymptomatic volunteers who have had clinically or microbiologically confirmed Mpox infection within the last one-month (group 2a) or more than one-month ago (group 2b)
* Those who have received a smallpox/MVA vaccine within the last one-month (group 2c) or more than one-month ago (group 2d)
* Group 3 (control cohort): asymptomatic volunteers with no known exposure to Mpox
The primary clinical aim of this study to develop novel immune diagnostics to estimate Mpox's sero-prevalence and determine exposure to Mpox virus and/or previous vaccination as a tool for vaccine prioritization among at risk populations.
Participants will be recruited from the following groups:
* Group 1 (suspected exposure cohort): asymptomatic volunteers at risk of Mpox including:
* Those who live within or adjacent to, or spend prolonged amounts of time in an epidemiologically identified region of Mpox transmission
* Close contacts of those with microbiologically confirmed Mpox
* Group 2 (post-exposure/vaccinated cohort):
* asymptomatic volunteers who have had clinically or microbiologically confirmed Mpox infection within the last one-month (group 2a) or more than one-month ago (group 2b)
* Those who have received a smallpox/MVA vaccine within the last one-month (group 2c) or more than one-month ago (group 2d)
* Group 3 (control cohort): asymptomatic volunteers with no known exposure to Mpox
Study Oversight
Has Oversight DMC:
False
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?: