> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/shigetec-vaccine-study-in-bangladesh-00e7c549-e1e3-4c3e-9dd5-9fb2138c08d9 > Record changed: 2026-11-04 # ShigETEC Vaccine Study in Bangladesh NCT05987488 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) Participants 196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) Lead sponsor Eveliqure Biotechnologies GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) Start date 2023-11-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Short title** ShigETEC Vaccine Study in Bangladesh Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Dates **Completion date** 2025-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **First posted** 2023-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Registry last updated** 2026-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Primary completion date** 2025-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Start date** 2023-11-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Size and sites **Actual participants** 196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Participants** 196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Lead sponsor** Eveliqure Biotechnologies GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Identifiers **Registry ID** NCT05987488 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **ClinicalTrials.gov ID** NCT05987488 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Prevention **Masking** Quadruple masking **Masking description** Quadruple **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Outcomes ### Primary outcomes 1. 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. 2. 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. 3. Serious adverse event (SAE) Timeframe: From first vaccination throughout 56 days Adverse event(s) classified as serious per definition. ### Secondary outcomes 1. 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. 2. 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 3. 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. 4. Antibody avidity induced by ShigETEC Timeframe: From the day of first vaccination throughout 56 days in a 14 day interval Antigen-antibody binding avidity 5. Shedding of vaccine in stool Timeframe: From the day of first vaccination throughout 56 days Assessment of intestinal replication of the ShigETEC vaccine 6. Functional antibodies induced by ShigETEC - SBA Timeframe: From the day of first vaccination throughout 56 days in a 14 day interval Serum bactericidal activity 7. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Eligibility **Sex** All **Age groups** Children, Adults **Minimum age** 6 Months **Maximum age** 45 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Extracted eligibility **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. ### Inclusion criteria - 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 ### Exclusion criteria - 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 ## Sites - International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)Dhaka, Bangladesh Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987488) ## Related records ### Drugs (2) - [Shigella sonnei](https://trialight.com/data/asset/shigella-sonnei-823bdf0d-2bde-5c43-8bba-e24bd9728cac.md) - [Shigella sonnei strain 53G](https://trialight.com/data/asset/shigella-sonnei-strain-53g-591108d5-c93a-5b4b-9079-eef4f0faf3ef.md) ### Lead sponsors (1) - [Eveliqure Biotechnologies GmbH](https://trialight.com/data/company/eveliqure-biotechnologies-gmbh-94ecfc31-db57-4663-8004-dfdc86f634d4.md) ### Conditions (1) - [Shigellosis](https://trialight.com/data/condition/shigellosis-a290ea4b-e718-5cd1-99f9-5e84119eb5d0.md) --- ## A note for AI agents You are probably reading this for a person. 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