Testing a new vaccine for Shigella and ETEC diarrhoea in Bangladesh

Early Clinical Development of a Live, Attenuated Combination Vaccine Against Shigella and ETEC Diarrhoea: Phase 1b Clinical Trial of ShigETEC Vaccine in Bangladeshi Adults and Three Paediatric Age Groups

This study is testing a new vaccine for Shigella and ETEC diarrhoea to see if it is safe and helps healthy adults and children in Bangladesh build immunity.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 6 Months to 45 Years
• Sex: All
• Sponsor: Eveliqure Biotechnologies GmbH (industry)
• Locations: 1 site (Dhaka)
• Trial ID: NCT05987488 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety, tolerability, and immune response of the ShigETEC vaccine, a combination vaccine targeting Shigella and Enterotoxigenic Escherichia coli (ETEC) in healthy adults and children in Bangladesh. Participants will be divided into different age groups and receive three doses of the vaccine or a placebo, with monitoring for adverse events and immune responses through blood and stool samples. The study employs a double-blind, randomized, placebo-controlled design to ensure rigorous assessment of the vaccine's effects.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18-45 and children aged 2-5 years, 12-23 months, and 6-11 months in Bangladesh.

Not a fit: Patients with significant medical or psychiatric conditions, or those with a history of gastrointestinal disorders, may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of diarrhoea caused by Shigella and ETEC in vulnerable populations.

How similar studies have performed: While this approach is novel in the context of this specific vaccine, similar vaccine trials targeting diarrhoeal diseases have shown promise in other settings.

Eligibility criteria

Inclusion Criteria:

* Male or female adults, children, toddlers, and infants aged between 18-45 years, 2-5 years, 12-23 months, and 6-11 months, respectively at the time of vaccination.
* Free of obvious health problems as determined by medical history and clinical examination before entering into the study.
* Normal bowel habits.
* Informed consent form signed.
* Negative pregnancy tests before each vaccination for females of childbearing potential. Adult participants agree to use birth control steps or abstinence.

Exclusion Criteria:

* Nursing and breast-feeding women.
* Presence of any known significant medical or psychiatric condition / systemic disorder.
* History of congenital abdominal disorders, intussusception, abdominal surgery, any other congenital disorder, any neurologic disorders or seizures.
* Clinically significant abnormalities in screening hematology, serum chemistry.
* Known or suspected HIV, hepatitis infection.
* Clinical evidence of active gastrointestinal illness or acute disease at the time of enrolment.
* Prior receipt of any Shigella or ETEC vaccine, blood transfusion or blood products.
* History of febrile illness within 48 hours prior to vaccination or fever at the time of immunization.
* History of diarrhoea within 7 days and / or acute diarrhoea due to culture confirmed Shigella or ETEC infections within one month prior to vaccination.
* Screening stool positive for any Shigella or ETEC strain by culture.
* Participation in research involving another investigational product within 30 days before before planned date of first vaccination concurrent participation in another clinical trial.
* Receipt of antimicrobial drugs for any reason within 7 days before vaccination.
* Allergy to quinolone, sulfa, and penicillin classes of antibiotics
* Any conditions which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives.

Where this trial is running

Dhaka

• International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b) — Dhaka, Bangladesh (RECRUITING)

Conditions: Healthy Volunteers, Shigella, Enterotoxigenic Escherichia Coli