ShigETEC Vaccine for Dysentery

Overseen By Kawsar Talaat, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Eveliqure Biotechnologies GmbH

Must not be taking: Antibiotics, Probiotics, Antacids, Steroids

Disqualifiers: Immunosuppressive condition, Gastrointestinal diseases, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral vaccine called ShigETEC to determine its effectiveness in preventing dysentery caused by the bacteria Shigella flexneri. Participants will receive either the vaccine or a placebo (a harmless substance resembling the vaccine) for comparison. The study targets healthy adults who are not pregnant or nursing and do not have chronic illnesses affecting daily life. Researchers seek individuals who have not recently had a Shigella infection and do not work closely with food or vulnerable populations. This trial may suit those who can commit to full participation. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as antibiotics, probiotics, prebiotics, synbiotics, and medications affecting stomach acid, for a specific period before receiving the vaccine and before the challenge. If you are on any medication that affects the immune system, you must stop it 30 days before the first vaccination.

Is there any evidence suggesting that the ShigETEC vaccine is likely to be safe for humans?

A previous study tested the ShigETEC vaccine in healthy adults. The results showed it was safe when administered four times at a dose of 5x10^10 CFU. Participants tolerated it well, and no major side effects occurred compared to those who received a placebo. These findings suggest the vaccine is generally safe for humans, making it a promising option for preventing dysentery caused by Shigella bacteria. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for dysentery, like antibiotics, work by directly killing bacteria, but ShigETEC is different because it's a live, attenuated oral vaccine designed to boost the body's immune response against the bacteria causing the illness. Unlike traditional methods that focus on treatment after infection, ShigETEC aims to prevent infection in the first place. This proactive approach could reduce reliance on antibiotics, which is crucial in combating antibiotic resistance. Researchers are excited because this vaccine could offer a new way to protect against dysentery outbreaks, especially in areas with limited access to medical care.

What evidence suggests that the ShigETEC vaccine might be an effective treatment for dysentery?

Research has shown that the ShigETEC vaccine, which participants in this trial may receive, may help protect against infections from Shigella and ETEC, a type of bacteria that can cause diarrhea. Studies in mice have demonstrated that the vaccine can protect against various types of Shigella. In tests with American travelers, the vaccine provided strong protection against severe ETEC illness, showing a 77% effectiveness rate. The vaccine has also proven to be safe and well-tolerated in people, even when administered multiple times at the tested dose. These results suggest that the ShigETEC vaccine could help prevent dysentery caused by Shigella infections. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Healthy adults aged 18 to 50 can join this study. They'll test a vaccine called ShigETEC against dysentery and shigellosis. Participants must be in good health as defined by the study's rules.

Inclusion Criteria

Participants must be determined eligible for the study based on medical history, physical examination, laboratory testing, and clinical judgment

Participants must provide written informed consent after the nature of the study has been explained

Participants must be available for the duration of the trial

Exclusion Criteria

Participants with evidence of current excessive alcohol consumption or drug dependence

Participants with current occupation involving handling of Shigella and ETEC bacteria

Any other criteria which, in the Investigator's opinion, would compromise the ability of the participant to participate in the study, the safety of the study, or the results of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive the ShigETEC vaccine or placebo on Days 1, 4, 7, and 10

2 weeks

4 visits (in-person)

Follow-up after Vaccination

Participants are monitored for safety and tolerability of the vaccine

6 days

Infectious Challenge

Participants are challenged with S. flexneri 2457T and monitored for signs and symptoms of shigellosis

Up to 28 days

Long-term Follow-up

Participants are monitored for safety and effectiveness, including serious adverse events, up to 12 months after last vaccination

12 months

What Are the Treatments Tested in This Trial?

Interventions

• ShigETEC vaccine

Trial Overview The trial is testing the ShigETEC vaccine's ability to prevent illness after being exposed to a bacteria that causes dysentery. First, volunteers get either the vaccine or a placebo, then they're exposed to the bacteria.

How Is the Trial Designed?

Group I: ShigETEC, a live, attenuated, oral vaccine Experimental Treatment 2 Interventions

Eligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10\^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10.

Group II: Placebo Placebo Group 2 Interventions

Eligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10\^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10.

Who Is Running the Clinical Trial?

Eveliqure Biotechnologies GmbH

Lead Sponsor

Trials

2

Recruited

260+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7712393/

Characterization of ShigETEC, a Novel Live Attenuated ... Results: Immunization with ShigETEC resulted in serotype independent protection in the mouse lung shigellosis model and induced high titer IgG ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0952791523000912

Developments in oral enterotoxigenic Escherichia coli ... The vaccine provided significant protective efficacy (PE 77%, p = 0.039) against nonmild ETEC disease in American travelers to Mexico and Guatemala, but not ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35214798/

Evaluation of the Safety, Tolerability and Immunogenicity ... Results: Oral immunization with ShigETEC was well tolerated and safe up to 4-time dosing with 5 × 1010 colony forming units. ShigETEC induced ...

4. firstwordpharma.com firstwordpharma.com/story/5983128

Eveliqure Announces Dosing of First Participants in a ... ShigETEC, an oral live, attenuated vaccine candidate, targets both Shigella and ETEC infections. It is based on an engineered Shigella vaccine ...

5. journals.asm.org journals.asm.org/doi/pdf/10.1128/iai.00368-25?download=true

Recent progress in enterotoxigenic Escherichia coli ... The preclinical efficacy data for this Shigella/ETEC combined vaccine are very encouraging. ... When excluding coinfections (the primary outcome), ...

6. trialx.com trialx.com/clinical-trials/listings/300179/safety-and-efficacy-study-of-shigetec-a-live-attenuated-oral-combination-vaccine-to-prevent-shigella-and-etec-disease-delivered-to-healthy-adults-ages-18-to-50-years-old/?&radius=50

Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, ... Overview. The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S.

7. euvaccine.eu euvaccine.eu/post/shigetec-vaccine-candidate-against-diarrhoeal-disease-proved-to-be-safe-in-phase-i-clinical-trial

ShigETEC vaccine candidate against diarrhoeal disease ... Following these promising data, a safety and immunogenicity study in adults and children from endemic areas is planned within the SHIGETECVAX ...

8. mdpi.com mdpi.com/2076-393X/10/2/340?type=check_update&version=1

Evaluation of the Safety, Tolerability and Immunogenicity ... Results: Oral immunization with ShigETEC was well tolerated and safe up to 4-time dosing with 5 × 1010 colony forming units. ShigETEC induced robust systemic ...