RecruitingShigellaDiarrhea

First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults

Eligible age

18–49 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults

Sponsor: Inventprise Inc.

✓ Participants who meet all the following criteria may be included in the study:
✓ 1. Age 18 to 49 years at the time of Dose 1
✓ 2. Good general health status, as determined by medical history, physical examination, safety laboratory tests, ECG, vital signs, and clinical judgment
✓ 3. BMI ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2
✓ 4. Negative alcohol breath test and urine drug screen results at Screening and on Day 1
✓ 5. All women: negative serum pregnancy test at Screening and negative urine pregnancy on Day 1
✓ 6. 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
✓ 7. Willingness to attend all protocol visits and to have all protocol-required procedures

✕ Participants who meet any of the following criteria will be excluded from the study:
✕ 1. Currently lactating
✕ 2. History of shigellosis or participation in a Shigella challenge study
✕ 3. History of bloody diarrhea without alternative diagnosis
✕ 4. History of inflammatory bowel disease
✕ 5. History of anaphylaxis or angioedema
✕ 6. History of malignancy, excluding nonmelanoma skin cancer, cervical carcinoma in situ, and malignancies considered cured \> 5 years prior to Day 1
✕ 7. 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.)

Cincinnati

Source: ClinicalTrials.gov · NCT07205926 · last updated 2025-11-19