Actively Recruiting
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
Led by Inventprise Inc. · Updated on 2025-11-19
60
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
CONDITIONS
Official Title
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 49 years at the time of Dose 1
- Good general health based on medical history, physical exam, lab tests, ECG, vital signs, and clinical judgment
- Body mass index between 18.0 and 32.0 kg/m2
- Negative alcohol breath test and urine drug screen at Screening and Day 1
- For all women, negative serum pregnancy test at Screening and negative urine pregnancy test on Day 1
- Women of childbearing potential must agree to use highly effective contraception through 28 days after last dose
- Willingness to attend all study visits and complete all required procedures
- Provide written informed consent
You will not qualify if you...
- Currently breastfeeding
- History of shigellosis or participation in a Shigella challenge study
- History of bloody diarrhea without alternative diagnosis
- History of inflammatory bowel disease
- History of anaphylaxis or angioedema
- History of malignancy except certain cured cancers
- History of diabetes mellitus except diet-controlled or gestational diabetes with normal glucose and no recent medication
- Known allergy to any ingredient in IVT Shigella-04
- Inadequate venous access for blood draws
- Abnormal lab test results outside normal range and grade 2 or higher toxicity
- Positive HIV-1 or HIV-2 antibody, hepatitis B surface antigen, or hepatitis C antibody tests
- Immunodeficiency or recent use of immunosuppressant drugs
- Previous Shigella vaccine receipt
- Planned receipt of other vaccines or investigational products during study
- Recent blood transfusion
- Planned elective hospitalization or surgery during study
- Occupational exposure to Shigella
- Living 6 months or more in low or lower-middle-income countries
- Employment by Inventprise, vendors, or study sites
- Any medical, psychiatric, substance use, or social condition that could interfere with study participation or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
6
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