Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-28 @ 9:30 AM
Study NCT ID:
NCT07049159
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old
Sponsor:
Eveliqure Biotechnologies GmbH
Organization:
Study Overview
Official Title:
A Two-stage, Phase 2b, Randomized, Double-blind, Placebo-controlled Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old
Status:
RECRUITING
Status Verified Date:
2025-06
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 evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T.
In Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10\^10 CFU. This dose was tested in a Phase 1 trial and found to be safe when given 4 times with an interval of 3 days between each dose.
The efficacy of ShigETEC vaccination will be evaluated in Stage 2 of this study, when participants will be challenged with S. flexneri 2457T.
The study population will be healthy adult participants in the age of 18-50 years (inclusive), which are clearly defined in the study protocol.
In Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10\^10 CFU. This dose was tested in a Phase 1 trial and found to be safe when given 4 times with an interval of 3 days between each dose.
The efficacy of ShigETEC vaccination will be evaluated in Stage 2 of this study, when participants will be challenged with S. flexneri 2457T.
The study population will be healthy adult participants in the age of 18-50 years (inclusive), which are clearly defined in the study protocol.
Detailed Description:
This is a two-stage, randomized, double blind, placebo-controlled Phase 2b study in healthy participants conducted at a single site.
The study will be conducted in two Stages (Stage 1 and Stage 2) and two arms in Stage 1 (Arm 1 and Arm 2).
Stage 1 Stage 1 will be conducted in an outpatient setting and includes the vaccination with the investigational product, ShigETEC, a live, attenuated, oral vaccine (Arm 1) and placebo (Arm 2) and subsequent follow-up.
Stage 2 Stage 2 will include an infectious challenge of selected Stage 1 participants in an inpatient setting (CHIM: Controlled Human Infection Model) in which participants will receive 1 oral dose of Shigella flexneri 2a 2457T and be followed closely for the signs and symptoms of shigellosis.
Stage 2 will start 21 (+5) days after the last dose of vaccine or placebo.
The study will be conducted in two Stages (Stage 1 and Stage 2) and two arms in Stage 1 (Arm 1 and Arm 2).
Stage 1 Stage 1 will be conducted in an outpatient setting and includes the vaccination with the investigational product, ShigETEC, a live, attenuated, oral vaccine (Arm 1) and placebo (Arm 2) and subsequent follow-up.
Stage 2 Stage 2 will include an infectious challenge of selected Stage 1 participants in an inpatient setting (CHIM: Controlled Human Infection Model) in which participants will receive 1 oral dose of Shigella flexneri 2a 2457T and be followed closely for the signs and symptoms of shigellosis.
Stage 2 will start 21 (+5) days after the last dose of vaccine or placebo.
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?: