Actively Recruiting
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
Led by Eveliqure Biotechnologies GmbH · Updated on 2025-07-08
72
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 50 years who are generally healthy, non-pregnant, and not nursing
- Eligible based on medical history, physical exam, laboratory tests, and clinical judgment
- Provide written informed consent after study explanation
- Available for the entire duration of the trial from enrollment to completion
- Able to understand and comply with all study requirements and instructions
- Body mass index (BMI) of 19 to less than 40 kg/m2
- Participants of child-bearing potential must agree to use effective contraception or abstain during the study until 29 days after challenge
- Willing to not smoke during any inpatient stay
- Willing to avoid participation in other investigational studies until this study ends
You will not qualify if you...
- Unavailability or difficulty in contacting during the study period
- Significant medical or psychiatric conditions that prevent study participation
- Abnormal blood tests exceeding grade 1 for potassium, ALT, creatinine, hemoglobin, white blood cells, or neutrophils
- Recent or anticipated blood product use or recent blood donation
- Use of systemic antibiotics, probiotics, prebiotics, synbiotics within 7 days before vaccination or proton pump inhibitors, H2 blockers, antacids within 48 hours before vaccination
- Immunosuppressive conditions, IgA deficiency, or impaired immune function
- Participation in another clinical trial within 30 days or incomplete clearance of experimental products
- Recent live or inactivated vaccine within 30 or 14 days before vaccination respectively
- Uncontrolled chronic non-gastrointestinal medical conditions
- Significant gastrointestinal diseases or surgery (excluding some specific surgeries)
- Positive tests for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody
- Personal or family history of reactive arthritis or HLA B-27 positive
- Occupations involving food handling, patient care, child or elder care
- Immunocompromised household members or children under 2 years in the household
- Recent Shigella or ETEC infection in last 5 years
- High serum IgG titer to Shigella flexneri 2a
- Irregular stool patterns or regular use of antidiarrheals, laxatives, or gastric pH modulators
- Allergies to specific antibiotics, polyethylene glycol, corn starch, or soy
- Autoimmune diseases in self or first-degree relatives
- Use of immune-affecting medications within 30 days before vaccination or planned use during study
- Previous vaccine against Shigella, cholera, ETEC, or LT toxin
- Dependence or close relation to study sponsor or team
- Excessive alcohol use or drug dependence
- Work involving handling Shigella or ETEC bacteria
- Any other conditions deemed by investigator to affect safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center for Immunization Research
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
K
Kawsar Talaat, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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