New combo vaccine targets deadly diarrhea in kids
NCT ID NCT05987488
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new vaccine called ShigETEC in healthy adults and children in Bangladesh. The vaccine aims to protect against two bacteria that cause severe diarrhea: Shigella and ETEC. Researchers gave three doses of the vaccine or a placebo to 196 participants to check if it is safe and triggers an immune response. The trial is a first step in developing a vaccine for these common infections.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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196 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)
Dhaka, Bangladesh
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Other studies related to the condition(s) this trial covers.
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