Ignite Creation Date:
2024-05-06 @ 1:36 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04078022
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2019-07-03
Brief Title:
Shigella CVD 30000 Study of Responses to Vaccination With Shigella Vaccine
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Phase 2b Study of the Safety Immunogenicity and Efficacy of a Monovalent Synthetic Carbohydrate-based Conjugate Vaccine SF2a-TT15 for Protection Against Shigella Flexneri 2a Experimental Infection
Status:
COMPLETED
Status Verified Date:
2024-05
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 SF2a-TT15 a monovalent synthetic carbohydrate-based conjugate Shigella vaccine is safe and effective in the prevention of Shigella infection
Detailed Description:
The purpose of this study is to determine whether SF2a-TT15 a monovalent synthetic carbohydrate-based conjugate Shigella vaccine is safe and effective in the prevention of Shigella infection This will be a phase 2b double-blind placebo-controlled single-center study involving a vaccination phase and a challenge phase The vaccination phase will consist of study participants that will be 11 randomized to receive either the vaccine or placebo Two doses of blinded study product will be given by intramuscular route of administration separated by approximately 4 weeks The challenge phase will consist of an inpatient stay of approximately 12 days during which eligible study participants will ingest an oral inoculum of wild-type S flexneri 2a strain 2457T and then be monitored for illness and treated with antibiotics when the primary endpoint is reached or upon 5 days post-challenge whichever comes first or when deemed necessary Upon satisfying discharge criteria study participants will complete outpatient clinic follow-up visits through 7 months after last dose of blinded study product Day 237 The efficacy study will be enrolled through three cohorts of participants each cohort consisting of approximately 30 subjects that will be involved in the vaccination phase and 22 subjects that will proceed with the challenge phase There will be a fourth cohort of participants consisting of 12 subjects that will receive the vaccine in an open-label design-this cohort will provide serum samples which are intended to be used for generating serum standards for laboratory assays as a part of ongoing and future clinical development of Shigella vaccines
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