xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05987488</url>
    </required_header>
    <id_info>
      <org_study_id>PR-19067</org_study_id>
      <nct_id>NCT05987488</nct_id>
    </id_info>
    <brief_title>ShigETEC Vaccine Study in Bangladesh</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eveliqure Biotechnologies GmbH</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eveliqure Biotechnologies GmbH</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against&#xD;
        Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric&#xD;
        participants of three different age groups (aged 2-5 years, 12-23 months and 6-11 months).&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Safety and clinical tolerability of the vaccine&#xD;
  &#xD;
          -  Immune responses generated by the vaccine In the age-descending dose-escalating study&#xD;
  &#xD;
          -  Adult participants will be divided into 2 escalating dose cohorts&#xD;
  &#xD;
          -  Each age group of paediatric participants will be divided into 3 escalating dose cohorts&#xD;
  &#xD;
          -  Participants in each cohort will receive three doses of vaccine/placebo two weeks apart&#xD;
  &#xD;
          -  Solicited and unsolicited adverse events (AE) and serious adverse events (SAE) will be&#xD;
             monitored after each vaccination dose&#xD;
  &#xD;
          -  Stool samples will be collected for immunological analysis and shedding of vaccine&#xD;
             strain&#xD;
  &#xD;
          -  Blood samples will be collected for immunological analysis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A double-blind, randomized, placebo-controlled, age-descending and dose-escalating phase 1b&#xD;
        clinical trial will be carried out in Bangladeshi adults and three paediatric age groups to&#xD;
        evaluate the safety, clinical tolerance, and immunogenicity of ShigETEC, a live, attenuated&#xD;
        Shigella/ETEC combination vaccine.&#xD;
  &#xD;
        Objectives of the study&#xD;
  &#xD;
        Primary Objectives:&#xD;
  &#xD;
        To evaluate the safety and clinical tolerability of oral ShigETEC vaccine in Bangladeshi&#xD;
        adults and different age groups of paediatric participants by monitoring the occurrence and&#xD;
        severity of clinical signs and symptoms after administration of each of the three&#xD;
        vaccinations.&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
          -  To evaluate the immune response to Shigella and ETEC (Enterotoxigenic Escherichia coli)&#xD;
             antigens in blood and stool following administration of ShigETEC vaccine.&#xD;
  &#xD;
          -  To assess the fecal shedding of ShigETEC following ingestion.&#xD;
  &#xD;
        The age-descending study will start testing the vaccine in healthy adults (aged 18-45 years)&#xD;
        and move subsequently into three different paediatric age groups (aged 2-5 years, 12-23&#xD;
        months and 6-11 months). In the adult participants (group A), thirty-six participants will be&#xD;
        enrolled and divided into 2 escalating dose cohorts. Each cohort of 18 healthy adults (12&#xD;
        vaccinees and 6 placebo recipients) will be randomized to receive three times vaccine/placebo&#xD;
        two weeks apart. The first adult cohort (cohort A1) will receive the optimal vaccine dose&#xD;
        (OVD) found in Phase I Europe trial (5x10^10 CFU). Cohort A2 will be given 4-fold higher dose&#xD;
        than cohort A1 (2x10^11 CFU).&#xD;
  &#xD;
        In each of the 2-5 years (group B), 12-23 months (group C), and 6-11 months age group (group&#xD;
        D), 48 participants will be enrolled and divided into 3 escalating dose cohorts with 16&#xD;
        participants in each cohort (12 vaccinees and 4 placebo recipients). B1 cohort will be&#xD;
        immunized with 25-fold lower than the OVD in EU (Europe) Phase 1 trial (2x10^9CFU). Cohorts&#xD;
        B2 and B3 will be given higher doses in 5-fold increments, and thus cohort B2 will receive&#xD;
        1x10^10 CFU and cohort B3 will receive the OVD in EU Phase 1 trial (5x10^10 CFU). Cohort C1&#xD;
        will be vaccinated with 25-fold lower than the OVD in group B. Cohorts C2 and C3 will receive&#xD;
        higher doses in 5-fold increments. Cohort D1 will be given 25- fold lower than the OVD in&#xD;
        group C. Cohorts D2 and D3 will receive higher doses in 5-fold increments.&#xD;
  &#xD;
        Recruitment, screening, and consenting of the participants will take place at the urban field&#xD;
        site of icddr,b in Mirpur. In each cohort, the first dose and immediate safety evaluation&#xD;
        will be conducted at the Clinical Trial Unit (CTU), an inpatient facility, where the&#xD;
        participants will be closely monitored for 24 hours post-vaccination. If the initial dose is&#xD;
        deemed safe, all participants will return to the CTU to receive the second and third time&#xD;
        vaccine or placebo on an outpatient basis. Follow-up visits will take place 7 days after each&#xD;
        dosing and 28 days after last dosing at the Mirpur field office.&#xD;
  &#xD;
        Primary safety endpoint:&#xD;
  &#xD;
          1. Solicited reactogenicity&#xD;
  &#xD;
          2. Unsolicited adverse event (AE)&#xD;
  &#xD;
          3. Serious adverse event (SAE)&#xD;
  &#xD;
        Secondary immunogenicity endpoints:&#xD;
  &#xD;
          1. Changes of antibody responses to antigens from baseline to each visit after vaccination:&#xD;
  &#xD;
               -  Antibody responses IgG (Immunglobulin G) and IgA (Immunglobulin A) in all age&#xD;
                  groups in serum&#xD;
  &#xD;
               -  IgA in lymphocyte supernatant (ALS) and fecal extract&#xD;
  &#xD;
          2. Functional antibodies:&#xD;
  &#xD;
               -  ETEC toxins neutralization titers&#xD;
  &#xD;
               -  Serum bactericidal activity&#xD;
  &#xD;
               -  Inhibition of bacterial adherence and entry to human colon epithelial cells&#xD;
  &#xD;
          3. Antibody responses to Shigella and ETEC proteins and peptides&#xD;
  &#xD;
          4. Antibody avidity against LT, ST and selected Shigella antigens&#xD;
  &#xD;
        Secondary shedding endpoint:&#xD;
  &#xD;
        Intestinal replication of the ShigETEC vaccine&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">April 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Quadruple</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Reactogenicity</measure>
      <time_frame>72 hours after vaccination</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unsolicited adverse event (AE)</measure>
      <time_frame>From first vaccination throughout 56 days</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serious adverse event (SAE)</measure>
      <time_frame>From first vaccination throughout 56 days</time_frame>
      <description>Adverse event(s) classified as serious per definition.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Antigen-specific Antibody titers induced by ShigETEC</measure>
      <time_frame>From the day of first vaccination throughout 56 days in a 14 day interval</time_frame>
      <description>Changes in IgG and IgA in plasma/serum, IgA in ALS and fecal extract to specific antigens from baseline to each visit after vaccination.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional antibodies induced by ShigETEC- neutralization</measure>
      <time_frame>From the day of first vaccination throughout 56 days in a 14 day interval</time_frame>
      <description>ETEC toxins neutralization titers&#xD;
  Serum bactericidal activity&#xD;
  Inhibition of bacterial adherence and entry to human colon epithelial cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characterization of the antibody repertoire induced by ShigETEC</measure>
      <time_frame>From the day of first vaccination throughout 56 days in a 14 day interval</time_frame>
      <description>Mapping of the vaccine-induced antibody for the entire Shigella proteome and ETEC toxin by high-resolution peptide and protein microarray assay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antibody avidity induced by ShigETEC</measure>
      <time_frame>From the day of first vaccination throughout 56 days in a 14 day interval</time_frame>
      <description>Antigen-antibody binding avidity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Shedding of vaccine in stool</measure>
      <time_frame>From the day of first vaccination throughout 56 days</time_frame>
      <description>Assessment of intestinal replication of the ShigETEC vaccine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional antibodies induced by ShigETEC - SBA</measure>
      <time_frame>From the day of first vaccination throughout 56 days in a 14 day interval</time_frame>
      <description>Serum bactericidal activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional antibodies induced by ShigETEC - adherence</measure>
      <time_frame>From the day of first vaccination throughout 56 days in a 14 day interval</time_frame>
      <description>Inhibition of bacterial adherence and entry to human colon epithelial cells</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>ShigETEC vaccine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>A saline solution with corn starch</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>ShigETEC live, attenuated, oral vaccine</intervention_name>
      <description>Vaccine will be delivered orally.&#xD;
  Stage 1:&#xD;
  Adults (18-45 years) will intake the vaccine 3 times 14 days apart in a dose escalating setting with two different doses.&#xD;
  Stage 2:&#xD;
  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.</description>
      <arm_group_label>ShigETEC vaccine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be delivered orally.&#xD;
  Stage 1:&#xD;
  Adults (18-45 years) will intake the placebo 3 times 14 days apart&#xD;
  Stage 2:&#xD;
  Children (2-5 years), Toddlers(12-23 months), Younger children (6-11 months) will intake the placebo 3 times 14 days apart.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female adults, children, toddlers, and infants aged between 18-45 years, 2-5&#xD;
               years, 12-23 months, and 6-11 months, respectively at the time of vaccination.&#xD;
  &#xD;
            -  Free of obvious health problems as determined by medical history and clinical&#xD;
               examination before entering into the study.&#xD;
  &#xD;
            -  Normal bowel habits.&#xD;
  &#xD;
            -  Informed consent form signed.&#xD;
  &#xD;
            -  Negative pregnancy tests before each vaccination for females of childbearing&#xD;
               potential. Adult participants agree to use birth control steps or abstinence.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Nursing and breast-feeding women.&#xD;
  &#xD;
            -  Presence of any known significant medical or psychiatric condition / systemic&#xD;
               disorder.&#xD;
  &#xD;
            -  History of congenital abdominal disorders, intussusception, abdominal surgery, any&#xD;
               other congenital disorder, any neurologic disorders or seizures.&#xD;
  &#xD;
            -  Clinically significant abnormalities in screening hematology, serum chemistry.&#xD;
  &#xD;
            -  Known or suspected HIV, hepatitis infection.&#xD;
  &#xD;
            -  Clinical evidence of active gastrointestinal illness or acute disease at the time of&#xD;
               enrolment.&#xD;
  &#xD;
            -  Prior receipt of any Shigella or ETEC vaccine, blood transfusion or blood products.&#xD;
  &#xD;
            -  History of febrile illness within 48 hours prior to vaccination or fever at the time&#xD;
               of immunization.&#xD;
  &#xD;
            -  History of diarrhoea within 7 days and / or acute diarrhoea due to culture confirmed&#xD;
               Shigella or ETEC infections within one month prior to vaccination.&#xD;
  &#xD;
            -  Screening stool positive for any Shigella or ETEC strain by culture.&#xD;
  &#xD;
            -  Participation in research involving another investigational product within 30 days&#xD;
               before before planned date of first vaccination concurrent participation in another&#xD;
               clinical trial.&#xD;
  &#xD;
            -  Receipt of antimicrobial drugs for any reason within 7 days before vaccination.&#xD;
  &#xD;
            -  Allergy to quinolone, sulfa, and penicillin classes of antibiotics&#xD;
  &#xD;
            -  Any conditions which, in the opinion of the investigator, might jeopardize the safety&#xD;
               of study participants or interfere with the evaluation of the study objectives.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)</name>
        <address>
          <city>Dhaka</city>
          <country>Bangladesh</country>
        </address>
      </facility>
      <contact>
        <last_name>Rubhana Raqib, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Bangladesh</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Shigella</keyword>
    <keyword>Enterotoxigenic Escherichia Coli</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05987488
  org study id: PR-19067
  nct id: NCT05987488
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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
  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:
  
          -  To evaluate the immune response to Shigella and ETEC (Enterotoxigenic Escherichia coli)
             antigens in blood and stool following administration of ShigETEC vaccine.
  
          -  To assess the fecal shedding of ShigETEC following ingestion.
  
        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), thirty-six participants will be
        enrolled and divided into 2 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).
  
        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:
  
          1. Solicited reactogenicity
  
          2. Unsolicited adverse event (AE)
  
          3. Serious adverse event (SAE)
  
        Secondary immunogenicity endpoints:
  
          1. Changes of antibody responses to antigens from baseline to each visit after vaccination:
  
               -  Antibody responses IgG (Immunglobulin G) and IgA (Immunglobulin A) in all age
                  groups in serum
  
               -  IgA in lymphocyte supernatant (ALS) and fecal extract
  
          2. Functional antibodies:
  
               -  ETEC toxins neutralization titers
  
               -  Serum bactericidal activity
  
               -  Inhibition of bacterial adherence and entry to human colon epithelial cells
  
          3. Antibody responses to Shigella and ETEC proteins and peptides
  
          4. Antibody avidity against LT, ST and selected Shigella antigens
  
        Secondary shedding endpoint:
  
        Intestinal replication of the ShigETEC vaccine
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Quadruple
  measure: Reactogenicity
  time frame: 72 hours after vaccination
  description: 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.
  measure: Unsolicited adverse event (AE)
  time frame: From first vaccination throughout 56 days
  description: 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.
  measure: Serious adverse event (SAE)
  time frame: From first vaccination throughout 56 days
  description: Adverse event(s) classified as serious per definition.
  measure: Antigen-specific Antibody titers induced by ShigETEC
  time frame: From the day of first vaccination throughout 56 days in a 14 day interval
  description: Changes in IgG and IgA in plasma/serum, IgA in ALS and fecal extract to specific antigens from baseline to each visit after vaccination.
  measure: Functional antibodies induced by ShigETEC- neutralization
  time frame: From the day of first vaccination throughout 56 days in a 14 day interval
  description: ETEC toxins neutralization titers
  Serum bactericidal activity
  Inhibition of bacterial adherence and entry to human colon epithelial cells
  measure: Characterization of the antibody repertoire induced by ShigETEC
  time frame: From the day of first vaccination throughout 56 days in a 14 day interval
  description: Mapping of the vaccine-induced antibody for the entire Shigella proteome and ETEC toxin by high-resolution peptide and protein microarray assay.
  measure: Antibody avidity induced by ShigETEC
  time frame: From the day of first vaccination throughout 56 days in a 14 day interval
  description: Antigen-antibody binding avidity
  measure: Shedding of vaccine in stool
  time frame: From the day of first vaccination throughout 56 days
  description: Assessment of intestinal replication of the ShigETEC vaccine
  measure: Functional antibodies induced by ShigETEC - SBA
  time frame: From the day of first vaccination throughout 56 days in a 14 day interval
  description: Serum bactericidal activity
  measure: Functional antibodies induced by ShigETEC - adherence
  time frame: From the day of first vaccination throughout 56 days in a 14 day interval
  description: Inhibition of bacterial adherence and entry to human colon epithelial cells
  arm group label: ShigETEC vaccine
  arm group type: Experimental
  description: 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.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: A saline solution with corn starch
  intervention type: Biological
  intervention name: ShigETEC live, attenuated, oral vaccine
  description: 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.
  arm group label: ShigETEC vaccine
  intervention type: Other
  intervention name: Placebo
  description: 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.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  country: Bangladesh
  responsible party type: Sponsor
  sharing ipd: No