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

NCT07049159 | Recruiting Phase 2 FDA Drug

• 1 other identifier: EVQ2001 / DMID 23-0009
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T. In Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10\^10 CFU. This dose was tested in a Phase 1 trial and found to be safe when given 4 times with an interval of 3 days between each dose. The efficacy of ShigETEC vaccination will be evaluated in Stage 2 of this study, when participants will be challenged with S. flexneri 2457T. The study population will be healthy adult participants in the age of 18-50 years (inclusive), which are clearly defined in the study protocol.

Conditions

Shigella

Outcome Measures

Primary Outcomes (1)

• Efficacy of the ShigETEC vaccine in preventing shigellosis caused by the challenge strain

  The proportion of participants with incidence of shigellosis caused by the challenge strain in vaccine vs. placebo recipients until the start of antibiotic administration.

  Up to study day 60

Secondary Outcomes (3)

• Safety and tolerability of ShigETEC oral vaccine

  Up to 12 months after last vaccination

• Characterization of the challenge strain shedding in stool samples

  Up to study day 40

• Severity of disease following challenge using Shigella disease score

  Up to day 40

Study Arms (2)

ShigETEC, a live, attenuated, oral vaccine

EXPERIMENTAL

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.

Biological: ShigETEC vaccine; Biological: Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo; Biological: Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU

Interventions

ShigETEC vaccine BIOLOGICAL

The ShigETEC vaccine will be administered orally 4 times at 3-day intervals as a bacterial suspension in a volume of 30 mL per dose (target to contain 5x10\^10 CFU)

ShigETEC, a live, attenuated, oral vaccine

Placebo OTHER

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.

Placebo

Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU BIOLOGICAL

In the challenge stage all participants will receive 1 oral dose of Shigella flexneri 2457T at a dose of 1.5x10\^3 CFU.

Placebo; ShigETEC, a live, attenuated, oral vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Generally healthy non-pregnant, non-nursing adults aged 18 to 50 years.
• Who are determined by medical history, physical examination, laboratory testing, and clinical judgment to be eligible for this study.
• Who provide written informed consent after the nature of the study had been explained.
• Who are available for the duration of the trial (from enrollment to study completion).
• Who are able to understand and are willing to comply with all study requirements, and willing to follow the instructions of the study staff and complete a comprehension test.
• Who have a body mass index (BMI) ≥19 and \<40 kg/m2.
• Participants of child-bearing potential must agree to avoid pregnancy throughout the study until 29 days following the challenge dose by use of an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable if it is a lifestyle choice (not just to participate in the study). If the participant is abstinent at the time of signing the informed consent and becomes sexually active, they must agree to use contraception as described. Participants who are unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
• Who are willing to not smoking during inpatient stay.
• Who are willing to refrain from participating in other studies of investigational products until completion of the last study visit.

You may not qualify if:

• Participants who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period.
• Presence of a significant medical or psychiatric condition which in the opinion of the Investigator precludes participation in the study.
• Clinically significant abnormalities in screening hematology or serum chemistry, defined as \> grade 1 abnormality of serum potassium, alanine aminotransferase (ALT) or creatinine, hemoglobin, white blood cell count (WBC), or neutrophil count.
• Who have received any blood products, including immunoglobulin, in the period from 6 months prior to vaccination or are anticipated to receive such products through to the conclusion of the study and have not donated blood within 30 days and agree not to donate blood until 1 year after challenge.
• Who are receiving systemic antibiotics, completed antibiotic therapy, or receiving probiotics, prebiotics or synbiotics in previous 7 days before vaccination, or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing with vaccine.
• Who have an immunosuppressive condition or IgA deficiency (serum IgA \<7 mg/dl or limit of detection of assay) or evidence of impaired immune function, either congenital, acquired, or iatrogenic.
• Who have or are participating in or have concluded participation in a clinical research study in the last 30 days or have not cleared the experimental product prior to vaccination.
• Received a live vaccine within 30 days before scheduled receipt of IP; or an inactivated vaccine within 14 days before scheduled receipt of IP.
• Who have a chronic non-gastrointestinal medical condition (e.g., hypertension, hyperlipidemia) that is not well controlled with medication.
• Presence of HIV antibody, HBsAg, or HCV antibody (if confirmed positive by HepC confirmatory test, i.e., recombinant immunoblot assay, PCR).
• Who have a personal or family history of reactive arthritis or are HLA B-27 positive and therefore at risk for developing reactive arthritis following naturally acquired bacterial gastrointestinal infection.
• Who work as a food handler or in direct patient, child day care, or elder care.
• Who have immunocompromised household member.
• Who have a child under the age of 2 living in their household.
• Who have had a culture proven Shigella or ETEC infection within the last 5 years.

Sponsors & Collaborators

• Eveliqure Biotechnologies GmbH: lead

Study Sites (1)

Center for Immunization Research

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Dysentery, Bacillary

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

Central Study Contacts

Kawsar Talaat, MD

CONTACT

+1 410-955-7283; ktalaat@jhu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): May 23, 2027
• Study Completion (Estimated): May 23, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

US (1)