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

NCT07205926 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IVT 514
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shigella; Diarrhea

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  At 28 days after each dose

Study Arms (6)

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

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

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

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

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

Biological: IVT Shigella-04

Placebo - 0.9% Saline

PLACEBO COMPARATOR

0.9% saline

Biological: Placebo (0.9% saline)

Interventions

IVT Shigella-04 BIOLOGICAL

Preventative vaccine for Shigella protection against 4 unique serotypes

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) BIOLOGICAL

Subjects dosed with 0.9% saline

Also known as: Placebo

Placebo - 0.9% Saline

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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
• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Inventprise Inc.: lead

Study Sites (1)

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

RECRUITING

MeSH Terms

Conditions

Dysentery, Bacillary; Diarrhea

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Chief Medical Officer

  Inventprise Inc.

  STUDY DIRECTOR

Central Study Contacts

Project Manager

CONTACT

866-290-2501; IVT514@inventprise.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects and investigators will be blinded to treatment assignment. The vaccine and placebo will be prepared and administered by dedicated unblinded staff not involved in other aspects of the study and will be concealed from the participant at the time of dosing. Unblinding will occur only after database lock or in the event of a medical emergency requiring knowledge of treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects are randomized in five groups in a 5:1, each receiving 2-doses of IVT Shigella-04 or placebo.

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: October 9, 2025
• Primary Completion: January 26, 2026
• Study Completion (Estimated): August 21, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)