First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-0… (NCT07205926) | Clinical Trial Compass
RecruitingPhase 1
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
United States60 participantsStarted 2025-10-09
Plain-language summary
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 to 49 years at the time of Dose 1
. Good general health status, as determined by medical history, physical examination, safety laboratory tests, ECG, vital signs, and clinical judgment
. BMI ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2
. Negative alcohol breath test and urine drug screen results at Screening and on Day 1
. All women: negative serum pregnancy test at Screening and negative urine pregnancy on Day 1
. Women of childbearing potential (see definition in Section 6.6.1): willingness to use a highly effective form of contraception (see list in Section 6.6.1) through 28 days after the last IP dose
. Willingness to attend all protocol visits and to have all protocol-required procedures
. Provision of written informed consent
Exclusion criteria
. Currently lactating
. History of shigellosis or participation in a Shigella challenge study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with reactogenicity events for 7 days after each dose
Timeframe: 7 days after Doses 1 and 2
2
Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 2
Timeframe: After Dose 1 to 6 months after Dose 2
3
Percentage of participants with medically attended AE's (MAAEs) from Dose 1 to 6 months after Dose 2
Timeframe: After Dose 1 to 6 months after Dose 2
4
Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from Dose 1 to 6 months after Dose 2
Timeframe: After Dose 1 to 6 months after Dose 2
5
Percentage of participants with AEs of special interest (AESIs) from Dose 1 to 6 months after Dose 2
Timeframe: After Dose 1 to 6 months after Dose 2
6
Percentage of participants with serious AEs (SAEs) from Dose 1 to 6 months after Dose 2
. History of bloody diarrhea without alternative diagnosis
. History of inflammatory bowel disease
. History of anaphylaxis or angioedema
. History of malignancy, excluding nonmelanoma skin cancer, cervical carcinoma in situ, and malignancies considered cured \> 5 years prior to Day 1
. History of diabetes mellitus (Individuals with diet-controlled diabetes or history of gestational diabetes are eligible if screening blood glucose is normal and there has been no requirement for antidiabetic medication in the last year.)
. Known hypersensitivity to any of the ingredients in IVT Shigella-04