Ignite Creation Date:
2024-05-06 @ 1:14 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03970304
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-07
First Post:
2019-05-29
Brief Title:
CVD 37000 Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
None
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
This is an open-label non-randomized study The purpose of this study is to better understand how vaccines against typhoid fever affect the normal immune system and bacteria in the intestine Patients having standard-of-care colonoscopies will be divided into 3 groups
Group 1 Vivotif typhoid vaccination then colonoscopy Group 2 Colonoscopy then Vivotif typhoid vaccination then follow-up colonoscopy Group 3 Colonoscopy without vaccination
The Vivotif typhoid vaccine used in this study is licensed by the Food and Drug Administration FDA for travelers to developing countries Volunteers will be asked to donate tissue blood saliva and stool samples for studying how the body responds to the typhoid vaccine
Group 1 Vivotif typhoid vaccination then colonoscopy Group 2 Colonoscopy then Vivotif typhoid vaccination then follow-up colonoscopy Group 3 Colonoscopy without vaccination
The Vivotif typhoid vaccine used in this study is licensed by the Food and Drug Administration FDA for travelers to developing countries Volunteers will be asked to donate tissue blood saliva and stool samples for studying how the body responds to the typhoid vaccine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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