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
Eveliqure Biotechnologies GmbH
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.
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 Infe…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria for stage 1: 1. Generally healthy non-pregnant, non-nursing adults aged 18 to 50 years. 2. Who are determined by medical history, physical examination, laboratory testing, and clinical judgment to be eligible for this study. 3. Who provide written informed consent after the nature of the study had been explained. 4. Who are available for the duration of the trial (from enrollment to study completion). 5. Who are able to understand and are willing to comply with all study requirements, and willing to follow the instructions of the study staff and complete a comprehension tes…
Interventions
- BiologicalShigETEC vaccine
The ShigETEC vaccine will be administered orally 4 times at 3-day intervals as a bacterial suspension in a volume of 30 mL per dose (target to contain 5x10\^10 CFU)
- OtherPlacebo
Eligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10\^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10.
- BiologicalChallenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU
In the challenge stage all participants will receive 1 oral dose of Shigella flexneri 2457T at a dose of 1.5x10\^3 CFU.
Location
- Center for Immunization ResearchBaltimore, Maryland