ShigETEC Vaccine Study in Bangladesh
- 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
- Short title
- ShigETEC Vaccine Study in Bangladesh
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-12-01
- First posted
- 2023-08-14
- Registry last updated
- 2026-01-23
- Primary completion date
- 2025-12-01
- Start date
- 2023-11-26
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eveliqure Biotechnologies GmbH
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05987488
- ClinicalTrials.gov ID
- NCT05987488
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masking description
- Quadruple
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Reactogenicity
Timeframe: 72 hours after vaccination
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.
Unsolicited adverse event (AE)
Timeframe: From first vaccination throughout 56 days
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.
Serious adverse event (SAE)
Timeframe: From first vaccination throughout 56 days
Adverse event(s) classified as serious per definition.
Antigen-specific Antibody titers induced by ShigETEC
Timeframe: From the day of first vaccination throughout 56 days in a 14 day interval
Changes in IgG and IgA in plasma/serum, IgA in ALS and fecal extract to specific antigens from baseline to each visit after vaccination.
Functional antibodies induced by ShigETEC- neutralization
Timeframe: From the day of first vaccination throughout 56 days in a 14 day interval
ETEC toxins neutralization titers * Serum bactericidal activity * Inhibition of bacterial adherence and entry to human colon epithelial cells
Characterization of the antibody repertoire induced by ShigETEC
Timeframe: From the day of first vaccination throughout 56 days in a 14 day interval
Mapping of the vaccine-induced antibody for the entire Shigella proteome and ETEC toxin by high-resolution peptide and protein microarray assay.
Antibody avidity induced by ShigETEC
Timeframe: From the day of first vaccination throughout 56 days in a 14 day interval
Antigen-antibody binding avidity
Shedding of vaccine in stool
Timeframe: From the day of first vaccination throughout 56 days
Assessment of intestinal replication of the ShigETEC vaccine
Functional antibodies induced by ShigETEC - SBA
Timeframe: From the day of first vaccination throughout 56 days in a 14 day interval
Serum bactericidal activity
Functional antibodies induced by ShigETEC - adherence
Timeframe: From the day of first vaccination throughout 56 days in a 14 day interval
Inhibition of bacterial adherence and entry to human colon epithelial cells
- Sex
- All
- Age groups
- Children, Adults
- Minimum age
- 6 Months
- Maximum age
- 45 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- Sex
- All
- Minimum age (years)
- 0
- Maximum age (years)
- 45
- Healthy volunteers
- Yes
Males and females aged 6 months to 45 years, free of significant health problems, eligible with informed consent and negative pregnancy testing for women of childbearing potential.
Male or female adults aged between 18-45 years
Source text not verified
Adults aged between 18-45 years at the time of vaccination
Source text: Male or female adults aged between 18-45 years
Source text not verified
Children aged between 2-5 years at the time of vaccination
Source text: children aged between 2-5 years
Source text not verified
Toddlers aged between 12-23 months at the time of vaccination
Source text: toddlers aged between 12-23 months
Source text not verified
Infants aged between 6-11 months at the time of vaccination
Source text: infants aged between 6-11 months
Source text not verified
Free of obvious health problems as determined by medical history and clinical examination before study entry
Source text: 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 females agree to use birth control or abstinence
Source text: Adult participants agree to use birth control steps or abstinence
Male or female
Nursing and breast-feeding women excluded
Source text: Nursing and breast-feeding women
Presence of any known significant medical or psychiatric condition or systemic disorder excluded
Source text: Presence of any known significant medical or psychiatric condition / systemic disorder
History of congenital abdominal disorders, intussusception, abdominal surgery, other congenital disorders, neurologic disorders or seizures excluded
Source text: History of congenital abdominal disorders, intussusception, abdominal surgery, any other congenital disorder, any neurologic disorders or seizures
Clinically significant abnormalities in screening hematology and serum chemistry excluded
Source text: Clinically significant abnormalities in screening hematology, serum chemistry
Known or suspected HIV or hepatitis infection excluded
Source text: Known or suspected HIV, hepatitis infection
Clinical evidence of active gastrointestinal illness or acute disease at enrolment excluded
Source text: 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 excluded
Source text: 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 excluded
Source text: 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 excluded
Source text: 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 excluded
Source text: Screening stool positive for any Shigella or ETEC strain by culture
Participation in research involving another investigational product within 30 days before planned date of first vaccination or concurrent participation in another clinical trial excluded
Source text: 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 excluded
Source text: Receipt of antimicrobial drugs for any reason within 7 days before vaccination
Allergy to quinolone, sulfa, and penicillin antibiotics excluded
Source text: Allergy to quinolone, sulfa, and penicillin classes of antibiotics
Any condition possibly jeopardizing safety or interfering with study evaluation as per investigator opinion excluded
Source text: 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
- International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)Dhaka, Bangladesh