Status:
RECRUITING
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
Lead Sponsor:
Inventprise Inc.
Conditions:
Shigella
Diarrhea
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
Detailed Description
A phase 1 single-site, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of a 2-dose regimen of IM injection of 5 dose formulations...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participants who meet all the following criteria may be included in the study:
- 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
- Participants who meet any of the following criteria will be excluded from the study:
- 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
- Inadequate venous access for repeated phlebotomy
- Any screening laboratory test result outside the normal range and grade ≥ 2 according to the FDA's toxicity grading scale for vaccine trials in healthy adults and adolescents; (Elevated creatine kinase and isolated elevations of bilirubin may be Grade 2 if hepatic transaminases are normal and the Investigator attributes the abnormality to exercise or Gilbert's syndrome. Potential cases of benign ethnic neutropenia should be discussed with the Medical Monitor)
- Positive serologic test for human HIV-1 or HIV-2 antibody, hepatitis B surface antigen, or hepatitis C antibody
- Immunodeficiency or chronic administration (\> 14 consecutive days) of immunosuppressant or other immune-modifying drugs (see details in Section 6.6.2), including systemic glucocorticoids, within 6 months before Day 1 (topical, intra-articular, or inhaled glucocorticoids permitted)
- Previous receipt of a licensed or investigational Shigella vaccine
- Planned receipt of any other vaccine through Day 57
- Receipt of blood transfusion or blood product within 6 months before Day 1 or planned receipt through Day 57
- Receipt of any other IP within 90 days before Day 1 or planned receipt through the end of the study
- Planned elective hospitalization or surgical procedure through the end of the study
- Occupational exposure to Shigella (eg, laboratory work)
- Residence ≥ 6 months in a low-income or lower-middle-income country as defined by the World Bank (https://datatopics.worldbank.org/world-development-indicators/the-world-by-income-and-region.html)
- Employee of Inventprise, vendors, or research sites associated with the study
- Any medical, psychiatric, substance use, or social condition that, in the judgment of the Investigator, may pose a risk to the participant or interfere with protocol adherence, assessment of study objectives, or ability to provide informed consent
- Temporary Delay Criteria
- Administration of IVT Shigella-04/placebo will be delayed for any participant who meets any of the following criteria:
- Receipt of any vaccine in the past 7 days
- Febrile illness (eg, oral temperature ≥ 38.0°C), diarrhea, or other acute illness in the past 48 hours
- Presence of any other sign, symptom, or medication use that could inhibit the proper vaccine administration of IVT Shigella-04/placebo or interpretation of diary data
- These criteria are temporary or self-limiting, and IVT Shigella-04/placebo may be administered once the time frame has elapsed/the condition has resolved.
Exclusion
Key Trial Info
Start Date :
October 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 21 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07205926
Start Date
October 9 2025
End Date
August 21 2026
Last Update
November 19 2025
Active Locations (1)
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1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227