Actively Recruiting
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
Led by Eveliqure Biotechnologies GmbH · Updated on 2025-07-08
72
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of the oral, live, attenuated ShigETEC vaccine in preventing illness caused by Shigella flexneri 2457T in healthy adults aged 18 to 50 years. This randomized, double-blind, placebo-controlled Phase 2b trial aims to evaluate how well the vaccine works against a controlled infection and to monitor its safety and tolerability. The study has two main parts. In Stage 1, participants receive either the ShigETEC vaccine or a placebo orally four times on Days 1, 4, 7, and 10. Stage 2 begins about three weeks after the last dose and involves an oral dose of the Shigella flexneri 2457T bacteria to assess the vaccine’s ability to prevent disease. Stage 2 is conducted in an inpatient setting with close monitoring for signs of infection. Participants will be closely followed throughout both stages, including assessments of health, laboratory tests, and monitoring of any symptoms or side effects. Researchers will measure vaccine effectiveness up to 60 days after challenge and track safety for up to 12 months. Additional evaluations include stool sample testing for bacterial shedding and disease severity scores. The total study duration includes vaccination, challenge, and follow-up periods to ensure thorough data collection.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Generally healthy non-pregnant, non-nursing adults aged 18 to 50 years.
- Eligible based on medical history, physical exam, lab tests, and clinical judgment.
- Provide written informed consent after study explanation.
- Available for the entire study duration.
- Able to understand and willing to comply with study requirements and instructions.
- Body mass index (BMI) of at least 19 and less than 40 kg/m2.
- Participants of child-bearing potential agree to use effective birth control or abstinence until 29 days after challenge.
- Willing to not smoke during inpatient stay.
- Willing to avoid participation in other investigational studies until study completion.
You will not qualify if you...
- Unavailable or difficult to contact for study visits during the study period.
- Significant medical or psychiatric conditions that prevent study participation.
- Clinically significant lab abnormalities (certain blood and chemistry values).
- Recent blood product receipt or donation restrictions.
- Recent or current use of antibiotics, probiotics, or medications affecting gastric pH near dosing.
- Immunosuppressive conditions, IgA deficiency, or impaired immune function.
- Recent participation in other clinical research or vaccine receipt within specified timeframes.
- Uncontrolled chronic medical conditions.
- Significant gastrointestinal diseases or surgeries.
- Positive for HIV, hepatitis B or C.
- Personal or family history of reactive arthritis or genetic risk.
- Employment in food handling or direct care roles.
- Household members who are immunocompromised or children under 2 years old.
- Prior Shigella or ETEC infection within 5 years.
- High serum IgG titer to Shigella flexneri 2a.
- Irregular stool patterns or regular use of certain gastrointestinal medications.
- Known allergies or intolerances to specific antibiotics, polyethylene glycol, corn starch, or soy.
- Personal or family history of autoimmune disease.
- Use of immune-affecting medications near study start.
- Prior vaccination against related bacteria or toxins.
- Sponsor or study team dependency or conflict.
- Evidence of excessive alcohol or drug use.
- Occupational exposure to Shigella or ETEC.
- Any other factors endangering safety or study integrity as judged by the Investigator.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive either the ShigETEC live oral vaccine or placebo given orally 4 times at 3-day intervals.
4 visits for dosing on Days 1, 4, 7, and 10
Duration - Approximately 21 days after last dose
Participants are followed for safety, tolerability, and assessment of vaccine efficacy until challenge.
Multiple follow-up visits in outpatient setting
Duration - Up to 19 days
Selected participants receive an oral dose of Shigella flexneri and are closely monitored inpatient for signs and symptoms of shigellosis.
Inpatient stay with daily monitoring visits
Duration - Up to 40 days after challenge
Participants are followed to assess disease severity and shedding of challenge strain in stool samples.
Multiple outpatient visits for assessments
Duration - Up to 12 months
Participants are monitored for safety and tolerability of the vaccine for up to 12 months after the last vaccination.
Periodic visits during the long-term monitoring period
Trial Site Locations
Total: 1 location
1
Center for Immunization Research
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
K
Kawsar Talaat, MD
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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