ShigellaPhase 1NCT07205926
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
A Phase 1 study testing IVT Shigella-04 in people with Shigella and Diarrhea, run by Inventprise Inc. at 1 site in United States.
Trial summary
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- What is being tested?
- IVT Shigella-04
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2025to 21 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
Medpace Clinical Pharmacology Unit, 513-366-3222, studyrecruitment@medpace.com
About this study
Official title: First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Safety and Immunogenicity of IVT Shigella-04 in Healthy Young Adults
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
Read the 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 of IVT Shigella-04 vaccine with and without adjuvant among 60 healthy individuals aged 18 to 49 years. Approximately 12 eligible participants will be enrolled in the specified 5 sequential dose cohorts and randomized in a 5:1 ratio to receive 2 IM injections of IVT Shigella-04 or placebo (normal saline) at a 28-day interval.
- Being tested
- IVT Shigella-04, Placebo (0.9% saline)
- Medical subject headings
- Dysentery, Bacillary, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVT Shigella-04Biological
Preventative vaccine for Shigella protection against 4 unique serotypes
Placebo (0.9% saline)Biological
Also called Placebo
Subjects dosed with 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Shigella-04 Low Dose without adjuvant (0.5 mL dose) | Experimental | Subjects will receive a 0.5 mL dose of the Shigella-04 low-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29 Receives: Biological: IVT Shigella-04 |
| Shigella-04 Low Dose with adjuvant (0.5 mL dose) | Experimental | Subjects will receive a 0.5 mL dose of the Shigella-04 low-dose formulation of each conjugated OPS, with adjuvant, administered via intramuscular injection on Day 1 and 29 Receives: Biological: IVT Shigella-04 |
| Shigella-04 Medium Dose without adjuvant (0.5 mL dose) | Experimental | Subjects will receive a 0.5 mL dose of the Shigella-04 medium-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29 Receives: Biological: IVT Shigella-04 |
| Shigella-04 Medium Dose with adjuvant (0.5 mL dose) | Experimental | Subjects will receive a 0.5 mL dose of the Shigella-04 medium-dose formulation of each conjugated OPS, with adjuvant, administered via intramuscular injection on Day 1 and 29 Receives: Biological: IVT Shigella-04 |
| Shigella-04 High Dose without adjuvant (1.0 mL dose) | Experimental | Subjects will receive a 1.0 mL dose of the Shigella-04 high-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29 Receives: Biological: IVT Shigella-04 |
| Placebo - 0.9% Saline | Placebo comparator | 0.9% saline Receives: Biological: Placebo (0.9% saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with reactogenicity events for 7 days after each dose
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: 7 days after Doses 1 and 2
Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: 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
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: 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
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: 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
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: 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
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: After Dose 1 to 6 months after Dose 2
Secondary outcomes (6)
Percentage of participants achieving 4-fold increase in anti-IpaB and serotype-specific anti-OPS immunoglobulin G (IgG) concentration at 28 days after each dose and 6 months after Dose 2
To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: At 28 days after each dose and 6 months after Dose 2
Geometric mean concentration (GMCs) of anti-IpaB and serotype-specific anti-OPS IgG at 28 days after each dose and 6 months after Dose 2
To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: At 28 days after each dose and 6 months after Dose 2
Geometric mean fold rises (GMFRs) in anti-IpaB and serotype-specific anti-OPS IgG concentration at 28 days after each dose and 6 months after Dose 2
To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: At 28 days after each dose and 6 months after Dose 2
Percentage of participants achieving 4-fold increase in serotype-specific anti-OPS functional antibody titer measured by serum bactericidal assay (SBA) at 28 days after each dose
To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: At 28 days after each dose
Geometric mean titers (GMTs) of serotype-specific anti-OPS functional antibody as measured by SBA at 28 days after each dose
To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: At 28 days after each dose
GMFRs in serotype-specific anti-OPS functional antibody titer as measured by SBA at 28 days after each dose
To assess the humoral immunogenicity of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Measured: At 28 days after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start9 Oct 2025
- Primary completion26 Jan 2026 (estimated)
- Study completion21 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShigellaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are randomized in five groups in a 5:1, each receiving 2-doses of IVT Shigella-04 or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inventprise Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Inventprise Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205926
- Sponsor's protocol ID
- IVT 514
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Safety and Immunogenicity of IVT Shigella-04 in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT07205926
- Acronym / sponsor ID
- IVT 514
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inventprise Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 26 Jan 2026 (estimated)
- Study completion
- 21 Aug 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of IVT Shigella-04 vaccine with and without adjuvant among 60 healthy individuals aged 18 to 49 years. Approximately 12 eligible participants will be enrolled in the specified 5 sequential dose cohorts and randomized in a 5:1 ratio to receive 2 IM injections of IVT Shigella-04 or placebo (normal saline) at a 28-day interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Subjects are randomized in five groups in a 5:1, each receiving 2-doses of IVT Shigella-04 or placebo.
| Arm | Type | Receives |
|---|---|---|
| Shigella-04 Low Dose without adjuvant (0.5 mL dose) | Experimental | Biological: IVT Shigella-04Subjects will receive a 0.5 mL dose of the Shigella-04 low-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29 |
| Shigella-04 Low Dose with adjuvant (0.5 mL dose) | Experimental | Biological: IVT Shigella-04Subjects will receive a 0.5 mL dose of the Shigella-04 low-dose formulation of each conjugated OPS, with adjuvant, administered via intramuscular injection on Day 1 and 29 |
| Shigella-04 Medium Dose without adjuvant (0.5 mL dose) | Experimental | Biological: IVT Shigella-04Subjects will receive a 0.5 mL dose of the Shigella-04 medium-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29 |
| Shigella-04 Medium Dose with adjuvant (0.5 mL dose) | Experimental | Biological: IVT Shigella-04Subjects will receive a 0.5 mL dose of the Shigella-04 medium-dose formulation of each conjugated OPS, with adjuvant, administered via intramuscular injection on Day 1 and 29 |
| Shigella-04 High Dose without adjuvant (1.0 mL dose) | Experimental | Biological: IVT Shigella-04Subjects will receive a 1.0 mL dose of the Shigella-04 high-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29 |
| Placebo - 0.9% Saline | Placebo comparator | Biological: Placebo (0.9% saline)0.9% saline |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVT Shigella-04Preventative vaccine for Shigella protection against 4 unique serotypes | Biological | Shigella-04 High Dose without adjuvant (1.0 mL dose), Shigella-04 Low Dose with adjuvant (0.5 mL dose), Shigella-04 Low Dose without adjuvant (0.5 mL dose), Shigella-04 Medium Dose with adjuvant (0.5 mL dose), Shigella-04 Medium Dose without adjuvant (0.5 mL dose) |
| Placebo (0.9% saline)Also: PlaceboSubjects dosed with 0.9% saline | Biological | Placebo - 0.9% Saline |
Primary outcome
Percentage of participants with reactogenicity events for 7 days after each dose
Time frame: 7 days after Doses 1 and 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 2
Time frame: After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with medically attended AE's (MAAEs) from Dose 1 to 6 months after Dose 2
Time frame: After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from Dose 1 to 6 months after Dose 2
Time frame: After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with AEs of special interest (AESIs) from Dose 1 to 6 months after Dose 2
Time frame: After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with serious AEs (SAEs) from Dose 1 to 6 months after Dose 2
Time frame: After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
6 secondary outcomes
Percentage of participants achieving 4-fold increase in anti-IpaB and serotype-specific anti-OPS immunoglobulin G (IgG) concentration at 28 days after each dose and 6 months after Dose 2
Time frame: At 28 days after each dose and 6 months after Dose 2
Geometric mean concentration (GMCs) of anti-IpaB and serotype-specific anti-OPS IgG at 28 days after each dose and 6 months after Dose 2
Time frame: At 28 days after each dose and 6 months after Dose 2
Geometric mean fold rises (GMFRs) in anti-IpaB and serotype-specific anti-OPS IgG concentration at 28 days after each dose and 6 months after Dose 2
Time frame: At 28 days after each dose and 6 months after Dose 2
Percentage of participants achieving 4-fold increase in serotype-specific anti-OPS functional antibody titer measured by serum bactericidal assay (SBA) at 28 days after each dose
Time frame: At 28 days after each dose
Geometric mean titers (GMTs) of serotype-specific anti-OPS functional antibody as measured by SBA at 28 days after each dose
Time frame: At 28 days after each dose
GMFRs in serotype-specific anti-OPS functional antibody titer as measured by SBA at 28 days after each dose
Time frame: At 28 days after each dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chief Medical Officer study director
Inventprise Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IVT Shigella-04 in people with Shigella and Diarrhea, run by Inventprise Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (866-290-2501, IVT514@inventprise.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with reactogenicity events for 7 days after each dose (time frame: 7 days after Doses 1 and 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.