Actively Recruiting
First-in-human Randomized Double-blind Placebo-controlled Dose-escalation Study Evaluating Safety and Immunogenicity of IVT Shigella-04 Vaccine in Healthy Young Adults
Led by Inventprise Inc. · Updated on 2025-11-19
60
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase 1 clinical trial to study the safety and immune response of a new vaccine called IVT Shigella-04 in healthy young adults aged 18 to 49 years. This study compares five different dose levels of the vaccine, given with or without an adjuvant, to a placebo. The goal is to evaluate how well the vaccine stimulates the immune system and to monitor any side effects. Participants will be randomly assigned to one of six groups to receive two intramuscular injections of either the IVT Shigella-04 vaccine at varying doses or a placebo (saline) 28 days apart. The vaccine formulations include low, medium, and high doses, some combined with an adjuvant to potentially enhance the immune response. The study is double-blind, meaning neither participants nor researchers know who receives the vaccine or placebo. During the trial, participants will attend scheduled visits for health assessments, blood tests, and monitoring of any reactions for up to six months after the second dose. Researchers will track immediate vaccine reactions, adverse events, and immune responses by measuring specific antibodies against Shigella. The total study duration for each participant includes screening, vaccination, and follow-up to ensure safety and gather detailed immune data.
CONDITIONS
Brief 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 first vaccine dose
- Good general health confirmed by medical history, physical exam, lab tests, ECG, and vital signs
- Body mass index between 18.0 and 32.0 kg/m2
- Negative alcohol breath test and urine drug screen at screening and on Day 1
- Women must have a negative pregnancy test at screening and on Day 1
- Women of childbearing potential must agree to use highly effective contraception through 28 days after the last vaccine dose
- Willingness to attend all study visits and complete required procedures
- Provide written informed consent
You will not qualify if you...
- Currently breastfeeding
- Prior shigellosis infection or participation in a Shigella challenge study
- History of bloody diarrhea without another diagnosis
- History of inflammatory bowel disease
- History of severe allergic reactions such as anaphylaxis or angioedema
- History of cancer except certain cured types more than 5 years ago
- History of diabetes mellitus unless diet-controlled with normal blood glucose and no recent medication
- Known allergy to ingredients in the IVT Shigella-04 vaccine
- Poor vein access for blood draws
- Abnormal lab tests graded 2 or higher per vaccine trial standards
- Positive tests for HIV, hepatitis B, or hepatitis C
- Immune system problems or recent use of immune-suppressing drugs
- Previous receipt of Shigella vaccine
- Planned other vaccinations through Day 57
- Recent or planned blood transfusions through Day 57
- Planned elective surgery or hospitalization during the study
- Occupational exposure to Shigella
- Living 6 months or more in low- or lower-middle-income countries
- Employment with Inventprise or study vendors
- Any medical, psychiatric, substance use, or social condition that may interfere with study participation or consent
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 - 28 days
Participants receive two intramuscular injections of the IVT Shigella-04 vaccine or placebo, 28 days apart, to evaluate safety and immune response.
2 visits (in-person) on Day 1 and Day 29
Duration - 6 months
Participants are monitored for safety and immune response for 6 months after the second dose.
Periodic visits up to 6 months after Dose 2
Trial Site Locations
Total: 1 location
1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Actively Recruiting
Research Team
P
Project Manager
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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