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Tests treatment safety and results for Shigella
Official title First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
ClinicalTrials.gov ID: NCT07205926
What this study is testing
What is IVT Shigella-04?
IVT Shigella-04 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for shigella.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.