MedTrace Logo

ShigETEC Vaccine Study in Bangladesh

NCT05987488 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-01-23

No results posted yet for this study

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

Interventions

BIOLOGICAL

ShigETEC live, attenuated, oral vaccine

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • Eveliqure Biotechnologies GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-26
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Bangladesh

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05987488 on ClinicalTrials.gov