A Phase 1 interventional study of ShigETEC live, attenuated, oral vaccine and Placebo in Healthy Volunteers, sponsored by Eveliqure Biotechnologies GmbH. Completed at 1 site in Bangladesh. Open to participants aged 6 Months to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Eveliqure Biotechnologies GmbH · Phase 1, Interventional, and Prevention
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:
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 safety, clinical tolerance, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine.
Objectives of the study
Primary Objectives:
To evaluate the safety and clinical tolerability of oral ShigETEC vaccine in Bangladeshi adults and different age groups of paediatric participants by monitoring the occurrence and severity of clinical signs and symptoms after administration of each of the three vaccinations.
Secondary Objectives:
The age-descending study will start testing the vaccine in healthy adults (aged 18-45 years) and move subsequently into three different paediatric age groups (aged 2-5 years, 12-23 months and 6-11 months). In the adult participants (group A), fifty-four participants will be enrolled and divided into 3 escalating dose cohorts. Each cohort of 18 healthy adults (12 vaccinees and 6 placebo recipients) will be randomized to receive three times vaccine/placebo two weeks apart. The first adult cohort (cohort A1) will receive the optimal vaccine dose (OVD) found in Phase I Europe trial (5x10\^10 CFU). Cohort A2 will be given 4-fold higher dose than cohort A1 (2x10\^11 CFU). Cohort A3 will receive a lower dose according to DSMB decision (2x10\^9 CFU).
In each of the 2-5 years (group B), 12-23 months (group C), and 6-11 months age group (group D), 48 participants will be enrolled and divided into 3 escalating dose cohorts with 16 participants in each cohort (12 vaccinees and 4 placebo recipients). B1 cohort will be immunized with 25-fold lower than the OVD in EU (Europe) Phase 1 trial (2x10\^9CFU). Cohorts B2 and B3 will be given higher doses in 5-fold increments, and thus cohort B2 will receive 1x10\^10 CFU and cohort B3 will receive the OVD in EU Phase 1 trial (5x10\^10 CFU). Cohort C1 will be vaccinated with 25-fold lower than the OVD in group B. Cohorts C2 and C3 will receive higher doses in 5-fold increments. Cohort D1 will be given 25- fold lower than the OVD in group C. Cohorts D2 and D3 will receive higher doses in 5-fold increments.
Recruitment, screening, and consenting of the participants will take place at the urban field site of icddr,b in Mirpur. In each cohort, the first dose and immediate safety evaluation will be conducted at the Clinical Trial Unit (CTU), an inpatient facility, where the participants will be closely monitored for 24 hours post-vaccination. If the initial dose is deemed safe, all participants will return to the CTU to receive the second and third time vaccine or placebo on an outpatient basis. Follow-up visits will take place 7 days after each dosing and 28 days after last dosing at the Mirpur field office.
Primary safety endpoint:
Secondary immunogenicity endpoints:
Changes of antibody responses to antigens from baseline to each visit after vaccination:
Functional antibodies:
Secondary shedding endpoint:
Intestinal replication of the ShigETEC vaccine
61 studies on the registry are indexed under Dysentery, Bacillary; 6 are open to participants now.
This study's enrollment of 196 is above the median of 76 across 54 interventional studies indexed under Dysentery, Bacillary.
Browse Dysentery, Bacillary studies →Eveliqure Biotechnologies GmbH is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The vaccine will consist of a suspension of a live, attenuated Shigella bacterial strain (a clinical isolate of Shigella flexneri 2457T strain) into which the genes for nontoxic forms of the ETEC heatlabile toxin B subunit (LTB) and a mutant heat stable toxin (STm) have been inserted.
Biological: ShigETEC live, attenuated, oral vaccine
A saline solution with corn starch
Other: Placebo
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.
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.
Reactogenicity
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.
Time frame: 72 hours after vaccination
Unsolicited adverse event (AE)
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.
Time frame: From first vaccination throughout 56 days
Serious adverse event (SAE)
Adverse event(s) classified as serious per definition.
Time frame: From first vaccination throughout 56 days
Antigen-specific Antibody titers induced by ShigETEC
Changes in IgG and IgA in plasma/serum, IgA in ALS and fecal extract to specific antigens from baseline to each visit after vaccination.
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Functional antibodies induced by ShigETEC- neutralization
ETEC toxins neutralization titers * Serum bactericidal activity * Inhibition of bacterial adherence and entry to human colon epithelial cells
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Characterization of the antibody repertoire induced by ShigETEC
Mapping of the vaccine-induced antibody for the entire Shigella proteome and ETEC toxin by high-resolution peptide and protein microarray assay.
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Antibody avidity induced by ShigETEC
Antigen-antibody binding avidity
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Shedding of vaccine in stool
Assessment of intestinal replication of the ShigETEC vaccine
Time frame: From the day of first vaccination throughout 56 days
Functional antibodies induced by ShigETEC - SBA
Serum bactericidal activity
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Functional antibodies induced by ShigETEC - adherence
Inhibition of bacterial adherence and entry to human colon epithelial cells
Time frame: From the day of first vaccination throughout 56 days in a 14 day interval
Plan to share: No
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Eveliqure Biotechnologies GmbH