ShigETEC Vaccine Study in Bangladesh

NCT05987488 | Completed Phase 1 DMC

• 1 other identifier: PR-19067
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5 years, 12-23 months and 6-11 months). The main question\[s\] it aims to answer are:

• Safety and clinical tolerability of the vaccine
• Immune responses generated by the vaccine In the age-descending dose-escalating study
• Adult participants will be divided into 2 escalating dose cohorts
• Each age group of paediatric participants will be divided into 3 escalating dose cohorts
• Participants in each cohort will receive three doses of vaccine/placebo two weeks apart
• Solicited and unsolicited adverse events (AE) and serious adverse events (SAE) will be monitored after each vaccination dose
• Stool samples will be collected for immunological analysis and shedding of vaccine strain
• Blood samples will be collected for immunological analysis

Conditions

Healthy Volunteers

Keywords

Shigella; Enterotoxigenic Escherichia Coli

Outcome Measures

Primary Outcomes (3)

• Reactogenicity

  Solicited adverse events in participants after vaccination. ShigETEC vaccine may result in symptoms similar to infection with Shigella or ETEC including fever, decreased appetite, irritability, decreased activity, abdominal pain, nausea, vomiting, loose stool, diarrhoea, dysentery, bloating, excess flatulence and constipation.

  72 hours after vaccination

• Unsolicited adverse event (AE)

  Any untoward medical occurrence in study participants during the conduct of a clinical trial, for which there is no or less possibility that the drug caused the event.

  From first vaccination throughout 56 days

• Serious adverse event (SAE)

  Adverse event(s) classified as serious per definition.

  From first vaccination throughout 56 days

Secondary Outcomes (7)

• Antigen-specific Antibody titers induced by ShigETEC

  From the day of first vaccination throughout 56 days in a 14 day interval

• Functional antibodies induced by ShigETEC- neutralization

  From the day of first vaccination throughout 56 days in a 14 day interval

• Characterization of the antibody repertoire induced by ShigETEC

  From the day of first vaccination throughout 56 days in a 14 day interval

• Antibody avidity induced by ShigETEC

  From the day of first vaccination throughout 56 days in a 14 day interval

• Shedding of vaccine in stool

  From the day of first vaccination throughout 56 days

Study Arms (2)

ShigETEC vaccine

EXPERIMENTAL

The vaccine will consist of a suspension of a live, attenuated Shigella bacterial strain (a clinical isolate of Shigella flexneri 2457T strain) into which the genes for nontoxic forms of the ETEC heatlabile toxin B subunit (LTB) and a mutant heat stable toxin (STm) have been inserted.

Biological: ShigETEC live, attenuated, oral vaccine

Placebo

PLACEBO COMPARATOR

A saline solution with corn starch

Other: Placebo

Interventions

ShigETEC live, attenuated, oral vaccine BIOLOGICAL

Vaccine will be delivered orally. Stage 1: Adults (18-45 years) will intake the vaccine 3 times 14 days apart in a dose escalating setting with two different doses. Stage 2: Children (2-5 years), Toddlers(12-23 months), Younger children (6-11 months) will intake the vaccine 3 times 14 days apart in a dose escalating setting with three different doses.

ShigETEC vaccine

Placebo OTHER

Placebo will be delivered orally. Stage 1: Adults (18-45 years) will intake the placebo 3 times 14 days apart Stage 2: Children (2-5 years), Toddlers(12-23 months), Younger children (6-11 months) will intake the placebo 3 times 14 days apart.

Placebo

Eligibility Criteria

• Age: 6 Months - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eveliqure Biotechnologies GmbH: lead

Study Sites (1)

International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Dysentery, Bacillary

Interventions

Vaccines

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

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: November 26, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)