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 range18 Years – 49 Years

SexALL

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
✕. 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

What they're measuring

Percentage of participants with reactogenicity events for 7 days after each dose

Timeframe: 7 days after Doses 1 and 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

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

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

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

Percentage of participants with serious AEs (SAEs) from Dose 1 to 6 months after Dose 2

Timeframe: After Dose 1 to 6 months after Dose 2

Trial details

NCT IDNCT07205926

SponsorInventprise Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-26

Contact for this trial

Project Manager

866-290-2501 IVT514@inventprise.com

View on ClinicalTrials.gov More Shigella trials

Who can participate

Age range18 Years – 49 Years

SexALL

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
✕. 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

What they're measuring

Percentage of participants with reactogenicity events for 7 days after each dose

Timeframe: 7 days after Doses 1 and 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

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

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

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

Percentage of participants with serious AEs (SAEs) from Dose 1 to 6 months after Dose 2

Timeframe: After Dose 1 to 6 months after Dose 2