Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634513
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2020-11-11
Brief Title:
Shigella CVD 31000 Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Phase 1 Study of the Safety Tolerability and Immunogenicity of Oral Doses of CVD 1208S-122 a Prototype Attenuated Shigella Flexneri 2a Live Vector Expressing Enterotoxigenic Escherichia Coli Antigens
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
The purpose of this study is to determine whether a live oral combined Shigella-ETEC vaccine candidate known as strain CVD 1208S-122 is safe and immunogenic
Detailed Description:
The purpose of this study is to determine whether a live oral combined Shigella-ETEC vaccine candidate known as strain CVD 1208S-122 is safe and immunogenic This will be a phase 1 double-blind placebo-controlled dose-escalating single-center study involving three vaccine dosage escalation cohorts 108 109 and 1010 cfu vaccine organisms Each of the three dose-escalation cohorts will consist of 8 study participants who will be randomly allocated to receive either vaccine n6 or placebo n2 as a single oral dose An independent Safety Monitoring Committee SMC will review the available safety data for Cohorts 1 - 3 through 7 days post-vaccination before proceeding to the enrollment of the next cohort The fourth cohort will be an adaptive design cohort consisting of 30 study participants to be randomly allocated to receive either two doses of vaccine n12 one dose of vaccine n12 or two doses of placebo n6 with the dosage selection based on the highest well-tolerated dose in the dose-escalation cohorts 1 - 3 as determined by the SMC
Each of the dose-escalation cohorts 1 - 3 will receive the oral dose of blinded study product while in the inpatient setting During the following subsequent 96 hours 4 days participants will remain on the inpatient research isolation ward to be closely monitored and each stool will be collected by study staff The evaluation and monitoring of participants enrolled in the fourth cohort will be conducted entirely in the outpatient setting
Each of the dose-escalation cohorts 1 - 3 will receive the oral dose of blinded study product while in the inpatient setting During the following subsequent 96 hours 4 days participants will remain on the inpatient research isolation ward to be closely monitored and each stool will be collected by study staff The evaluation and monitoring of participants enrolled in the fourth cohort will be conducted entirely in the outpatient setting
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