Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539351
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
A Pilot Study to Finetune Skin Processing Procedures in Recent Vaccinees Prior to GeKoSkimm Study Initiation GeKoSkimm-pilot
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study to Finetune Skin Processing Procedures in Recent Vaccinees Prior to GeKoSkimm Study Initiation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study aims to optimize the sample processing techniques for collecting and analyzing skin biopsies obtained from individuals routinely vaccinated against yellow fever By addressing logistical challenges early risks will be mitigated and the main studys efficiency will be enhanced
In order to do so 15 participants will be identified at the ITM polyclinic after receiving a yellow fever vaccination Participants will be invited to one study visit at the ITM Clinical Trial Site CTS 28 days after vaccination to collect blood samples skin punch biopsies and a minimally-invasive microbiopsy at the site of vaccination To investigate the ideal location for the skin punch biopsies participants will be divided in 3 groups in the first 5 participants the biopsies will be taken directly on the vaccination site for the next 5 participants the biopsies will be taken at - 3 cm distance from the vaccination site and for the last five participants the biopsies will be taken at - 10 cm distance from the vaccination site
In order to do so 15 participants will be identified at the ITM polyclinic after receiving a yellow fever vaccination Participants will be invited to one study visit at the ITM Clinical Trial Site CTS 28 days after vaccination to collect blood samples skin punch biopsies and a minimally-invasive microbiopsy at the site of vaccination To investigate the ideal location for the skin punch biopsies participants will be divided in 3 groups in the first 5 participants the biopsies will be taken directly on the vaccination site for the next 5 participants the biopsies will be taken at - 3 cm distance from the vaccination site and for the last five participants the biopsies will be taken at - 10 cm distance from the vaccination site
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None