Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03705585
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2018-10-04
Brief Title:
CVD 38000 Study of Responses to Vaccination With Typhoid andor Cholera
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
CVD 38000 Immunity Microbiome Epigenetics and a Systems Biology Approach to the Study of Responses to Vaccination With Typhoid andor Cholera
Status:
RECRUITING
Status Verified Date:
2024-01
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 and cholera affect the normal immune system and bacteria in the intestine Patients having standard-of-care endoscopies colonoscopy andor esophagogastroduodenoscopy EGD will be divided into 3 groups
Group 1 Vivotif typhoid vaccination andor Vaxchora cholera vaccination then endoscopy Group 2 Endoscopy then Vivotif typhoid vaccination andor Vaxchora cholera vaccination then follow-up endoscopy Group 3 Endoscopy without vaccination
Both vaccines used in this study are 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 andor cholera vaccine
Group 1 Vivotif typhoid vaccination andor Vaxchora cholera vaccination then endoscopy Group 2 Endoscopy then Vivotif typhoid vaccination andor Vaxchora cholera vaccination then follow-up endoscopy Group 3 Endoscopy without vaccination
Both vaccines used in this study are 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 andor cholera 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?:
True
Is an FDA AA801 Violation?:
None