Status:
RECRUITING
ShigETEC Vaccine Study in Bangladesh
Lead Sponsor:
Eveliqure Biotechnologies GmbH
Conditions:
Healthy Volunteers
Eligibility:
All Genders
6-45 years
Phase:
PHASE1
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 dif...
Detailed Description
A double-blind, randomized, placebo-controlled, age-descending and dose-escalating phase 1b clinical trial will be carried out in Bangladeshi adults and three paediatric age groups to evaluate the saf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05987488
Start Date
November 26 2023
End Date
December 1 2025
Last Update
May 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)
Dhaka, Bangladesh