Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615375
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 2b Double-blind Placebo-controlled Efficacy Challenge Study with the Shigella Tetravalent Bioconjugate Vaccine Shigella4V2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
S4V03
Brief Summary:
In this challenge study the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain compared to participants receiving placebo
Detailed Description:
The tetravalent Shigella4V2 bioconjugate vaccine candidate will be tested for safety and preliminary efficacy in a Phase 2b controlled human infection model CHIM study at three sites in the United States This trial will be conducted as a parallel-group randomized double-blind multicenter placebo-controlled study to evaluate the safety immunogenicity and efficacy of one dose of Shigella4V2 in healthy Shigella naïve participants 18-50 years of age administered one month before challenge with S sonnei 53G strain It will have two steps
1 Step 1 a dose selection step in which participants will receive either one of two doses of Shigella4V2 high dose or low dose adjuvanted with Alhydrogel or placebo phosphate-buffered saline at a ratio of 221 to find the optimal immunogenic dose for Step 2 and
2 Step 2 in which participants will be randomized to either the Shigella4V2 dose selected in Step 1 or to placebo at a ratio of 11 One month after injection they will be challenged with 1500 CFU of the virulent Shigella sonnei strain 53G In order to assess the ability of Shigella4V2 to protect against infection with this strain the attack rate of shigellosis in the group vaccinated with Shigella4V2 will be compared to the group of the participants who received placebo injections
1 Step 1 a dose selection step in which participants will receive either one of two doses of Shigella4V2 high dose or low dose adjuvanted with Alhydrogel or placebo phosphate-buffered saline at a ratio of 221 to find the optimal immunogenic dose for Step 2 and
2 Step 2 in which participants will be randomized to either the Shigella4V2 dose selected in Step 1 or to placebo at a ratio of 11 One month after injection they will be challenged with 1500 CFU of the virulent Shigella sonnei strain 53G In order to assess the ability of Shigella4V2 to protect against infection with this strain the attack rate of shigellosis in the group vaccinated with Shigella4V2 will be compared to the group of the participants who received placebo injections
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