IVT Shigella-04 Vaccine for Dysentery

Overseen By Project Manager

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Inventprise Inc.

Must not be taking: Immunosuppressants, Glucocorticoids

Disqualifiers: Lactating, Shigellosis, Diabetes, HIV, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine, IVT Shigella-04, designed to prevent dysentery, a severe diarrhea caused by Shigella bacteria. Researchers aim to determine if this vaccine is safe and if it stimulates the body to produce antibodies, which fight infections. Participants will receive different doses of the vaccine, with some receiving an adjuvant, an extra ingredient that might enhance the vaccine's effectiveness. The trial seeks healthy young adults who have not experienced shigellosis or related symptoms like bloody diarrhea. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant or immune-modifying drugs, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the IVT Shigella-04 vaccine is in the early testing phase. This vaccine aims to protect against Shigella, a bacterium that can cause stomach issues like diarrhea and fever. Initial studies with healthy young adults tested the vaccine in various doses, sometimes with an added substance to boost the immune response.

Currently, detailed information on vaccine tolerance is unavailable because it is being tested in humans for the first time. As a Phase 1 trial, the primary goal is to assess safety and identify any side effects. The focus is on ensuring it doesn't cause serious problems before advancing to larger tests.

Phase 1 studies like this one are generally small and closely monitored. They are designed to identify any safety issues early, ensuring potential side effects are detected before proceeding to larger trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the IVT Shigella-04 vaccine for dysentery because it offers a potentially innovative approach to preventing Shigella infections, which are a leading cause of dysentery. Unlike traditional antibiotics that treat infections after they occur, this vaccine aims to prevent them in the first place. The Shigella-04 vaccine is unique because it uses a conjugated OPS formulation, which may offer enhanced immune response compared to conventional vaccines. Additionally, some formulations of the vaccine include an adjuvant, a substance that boosts the body's immune response to the vaccine, potentially increasing its efficacy. This proactive strategy could reduce the prevalence of antibiotic-resistant strains and improve public health outcomes.

What evidence suggests that this trial's treatments could be effective for dysentery?

Studies have shown that the IVT Shigella-04 vaccine aims to reduce illness and deaths from shigellosis, a bacterial infection causing severe diarrhea. This trial will evaluate different formulations of the Shigella-04 vaccine, including low, medium, and high doses, with and without an adjuvant, as well as a placebo. Research indicates that vaccines like Shigella-04 can help the immune system fight these infections. Early results suggest that the vaccine can trigger an immune response, potentially offering protection against the disease. Although human studies have provided limited data, the vaccine's goal is to decrease the number and severity of shigellosis cases. ^{1 2 3 6 7}

Who Is on the Research Team?

Chief Medical Officer

Principal Investigator

Inventprise Inc.

Are You a Good Fit for This Trial?

This trial is for healthy young adults who want to help test a new vaccine against Shigella, which causes dysentery and travelers' diarrhea. Participants should not have any history of Shigella infection or previous vaccination against it.

Inclusion Criteria

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

Exclusion Criteria

Currently lactating

History of shigellosis or participation in a Shigella challenge study

History of anaphylaxis or angioedema

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 intramuscular injections of IVT Shigella-04 or placebo at a 28-day interval

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and immunogenicity

6 months

What Are the Treatments Tested in This Trial?

Interventions

• IVT Shigella-04

Trial Overview The study is testing the safety and immune response to IVT's Shigella-04 vaccine compared to a saline placebo. It's an early-stage (Phase 1) trial where doses are gradually increased to find the safest effective amount.

How Is the Trial Designed?

Group I: Shigella-04 Medium Dose without adjuvant (0.5 mL dose) Experimental Treatment 1 Intervention

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

Group II: Shigella-04 Medium Dose with adjuvant (0.5 mL dose) Experimental Treatment 1 Intervention

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

Group III: Shigella-04 Low Dose without adjuvant (0.5 mL dose) Experimental Treatment 1 Intervention

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

Group IV: Shigella-04 Low Dose with adjuvant (0.5 mL dose) Experimental Treatment 1 Intervention

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

Group V: Shigella-04 High Dose without adjuvant (1.0 mL dose) Experimental Treatment 1 Intervention

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

Group VI: Placebo - 0.9% Saline Placebo Group 1 Intervention

0.9% saline

Who Is Running the Clinical Trial?

Inventprise Inc.

Lead Sponsor

Trials

4

Recruited

1,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07205926

NCT07205926 | First in Human Dose Escalation Study ... First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults.

2. inventprise.com inventprise.com/pipeline/

Pipeline Inventprise is developing IVT Shigella-04, a quadrivalent conjugate vaccine, which aims to reduce morbidity and mortality from shigellosis, and might also have ...

3. withpower.com withpower.com/trial/phase-1-dysentery-bacillary-9-2025-ee3c2

IVT Shigella-04 Vaccine for Dysentery Trial Overview The study is testing the safety and immune response to IVT's Shigella-04 vaccine compared to a saline placebo. It's an early-stage (Phase 1) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06615375?cond=Shigellosis%20OR%20%22bacillary%20dysentery%22%20OR%20%22%20Shigella%20gastroenteritis%22&aggFilters=status:not%20rec&viewType=Table&rank=4

NCT06615375 | A Human Challenge Study to Assess ... In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy ...

5. inventprise.com inventprise.com/pipeline-rev-11/

Pipeline-REV-11 IVT Shigella-04: Shigella Vaccine​​ Inventprise is developing a Shigella conjugate vaccine which aims to have the direct potential to reduce morbidity and ...

6. who.int who.int/teams/immunization-vaccines-and-biologicals/diseases/shigella

Shigella (Immunization, Vaccines and Biologicals). Drug resistant Shigella has been identified as a pathogen for which there is a priority to develop antimicrobials(4). WHO is evaluating the role of vaccines ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9504713/

The Shigella Vaccines Pipeline - PMC A Shigella vaccine must be safe, immunogenic and efficacious against moderate-to-severe diarrhea (MSD) due to Shigella infection among the key ...