ShigellaPhase 2NCT07049159
Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old
A Phase 2 study testing ShigETEC vaccine and Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU in people with Shigella, run by Eveliqure Biotechnologies GmbH at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T. In Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10^10 CFU. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Shigella
- What is being tested?
- ShigETEC vaccine and Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 23 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy non-pregnant, non-nursing adults aged 18 to 50 years.
- Who are determined by medical history, physical examination, laboratory testing, and clinical judgment to be eligible for this study.
- Who provide written informed consent after the nature of the study had been explained.
- Who are available for the duration of the trial (from enrollment to study completion).
- Who are able to understand and are willing to comply with all study requirements, and willing to follow the instructions of the study staff and complete a comprehension test.
- Who have a body mass index (BMI) ≥19 and <40 kg/m2.
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- Participants of child-bearing potential must agree to avoid pregnancy throughout the study until 29 days following the challenge dose by use of an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable if it is a lifestyle choice (not just to participate in the study). If the participant is abstinent at the time of signing the informed consent and becomes sexually active, they must agree to use contraception as described. Participants who are unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
- Who are willing to not smoking during inpatient stay.
- Who are willing to refrain from participating in other studies of investigational products until completion of the last study visit.
- Only participants meeting the above inclusion/exclusion criteria and the additional following criteria at Stage 2 study entry are eligible to be in Stage 2:
- Who received 4 doses of vaccine or placebo.
- Who are SARS-COV-2 negative.
- Who do not have an ongoing grade 2 or higher AE.
- Who have negative pregnancy test (participants with child-bearing potential).
- Who have not experienced diarrhea in the 7 days before challenge.
- Who have not taken antibiotics, probiotics, prebiotics or synbiotics in the previous 7 days before challenge.
- Who did not use anti-diarrheal, anti-constipation drugs within 7 days before challenge.
- Who did not use proton pump inhibitors, H2 blockers or antacid therapy 48 hours prior to challenge.
Who cannot join
- Participants who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period.
- Presence of a significant medical or psychiatric condition which in the opinion of the Investigator precludes participation in the study.
- Clinically significant abnormalities in screening hematology or serum chemistry, defined as > grade 1 abnormality of serum potassium, alanine aminotransferase (ALT) or creatinine, hemoglobin, white blood cell count (WBC), or neutrophil count.
- Who have received any blood products, including immunoglobulin, in the period from 6 months prior to vaccination or are anticipated to receive such products through to the conclusion of the study and have not donated blood within 30 days and agree not to donate blood until 1 year after challenge.
- Who are receiving systemic antibiotics, completed antibiotic therapy, or receiving probiotics, prebiotics or synbiotics in previous 7 days before vaccination, or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing with vaccine.
- Who have an immunosuppressive condition or IgA deficiency (serum IgA <7 mg/dl or limit of detection of assay) or evidence of impaired immune function, either congenital, acquired, or iatrogenic.
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- Who have or are participating in or have concluded participation in a clinical research study in the last 30 days or have not cleared the experimental product prior to vaccination.
- Received a live vaccine within 30 days before scheduled receipt of IP; or an inactivated vaccine within 14 days before scheduled receipt of IP.
- Who have a chronic non-gastrointestinal medical condition (e.g., hypertension, hyperlipidemia) that is not well controlled with medication.
- Who have a significant history of or current diagnosis of diseases of the gastrointestinal tract (i.e., liver, gallbladder, bowel, or stomach), including inflammatory bowel disease, are on medication for such disease, or have had significant bowel surgery (with the exclusion of hernia repair, cholecystectomy, or appendectomy).
- Presence of HIV antibody, HBsAg, or HCV antibody (if confirmed positive by HepC confirmatory test, i.e., recombinant immunoblot assay, PCR).
- Who have a personal or family history of reactive arthritis or are HLA B-27 positive and therefore at risk for developing reactive arthritis following naturally acquired bacterial gastrointestinal infection.
- Who work as a food handler or in direct patient, child day care, or elder care.
- Who have immunocompromised household member.
- Who have a child under the age of 2 living in their household.
- Who have had a culture proven Shigella or ETEC infection within the last 5 years.
- Who have a serum IgG titer >2500 to Shigella flexneri 2a.
- Who have regularly abnormal stool patterns (fewer than 3 stools per week or more than 3 stools per day) or loose or liquid stools.
- Who regularly use antidiarrheals, laxatives or any agents modulating gastric pH (regular defined as at least weekly).
- Who have known allergy to 2 of the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole or ampicillin.
- Who have known intolerance or allergy against polyethylene glycol (PEG); or corn starch.
- Who have known intolerance or allergy to soy.
- Who have personal history of or first-degree family member with an autoimmune disease.
- Use any medication known to affect the immune function (e.g., systemic steroids) within 30 days preceding the first vaccination or planned use during the entire study period.
- Who received an investigational or licensed vaccine against shigella, cholera, ETEC and/or LT toxin.
- Who are dependent of the Sponsor, of the investigational team or his/her immediate family or are students of the professors at the clinical study site.
- Who have evidence of current excessive alcohol consumption or drug dependence.
- Current occupation involving handling of Shigella and ETEC bacteria.
- Any other criteria which, in the Investigator's opinion, would compromise the ability of the participant to participate in the study, the safety of the study, or the results of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Immunization Research
Baltimore, Maryland, 21205
Kawsar Talaat
About this study
Official title: A Two-stage, Phase 2b, Randomized, Double-blind, Placebo-controlled Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old
The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T.
In Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10^10 CFU. This dose was tested in a Phase 1 trial and found to be safe when given 4 times with an interval of 3 days between each dose.
The efficacy of ShigETEC vaccination will be evaluated in Stage 2 of this study, when participants will be challenged with S. flexneri 2457T.
The study population will be healthy adult participants in the age of 18-50 years (inclusive), which are clearly defined in the study protocol.
Read the detailed description
This is a two-stage, randomized, double blind, placebo-controlled Phase 2b study in healthy participants conducted at a single site.
The study will be conducted in two Stages (Stage 1 and Stage 2) and two arms in Stage 1 (Arm 1 and Arm 2).
Stage 1 Stage 1 will be conducted in an outpatient setting and includes the vaccination with the investigational product, ShigETEC, a live, attenuated, oral vaccine (Arm 1) and placebo (Arm 2) and subsequent follow-up.
Stage 2 Stage 2 will include an infectious challenge of selected Stage 1 participants in an inpatient setting (CHIM: Controlled Human Infection Model) in which participants will receive 1 oral dose of Shigella flexneri 2a 2457T and be followed closely for the signs and symptoms of shigellosis.
Stage 2 will start 21 (+5) days after the last dose of vaccine or placebo.
- Conditions
- Shigella
- Being tested
- ShigETEC vaccine, Placebo, Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU
- Medical subject headings
- Dysentery, Bacillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShigETEC vaccineBiological
The ShigETEC vaccine will be administered orally 4 times at 3-day intervals as a bacterial suspension in a volume of 30 mL per dose (target to contain 5x10^10 CFU)
PlaceboOther
Eligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10.
Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFUBiological
In the challenge stage all participants will receive 1 oral dose of Shigella flexneri 2457T at a dose of 1.5x10^3 CFU.
| Study group | Role | What they receive |
|---|---|---|
| ShigETEC, a live, attenuated, oral vaccine | Experimental | Eligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10. Receives: Biological: ShigETEC vaccine; Biological: Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU |
| Placebo | Placebo comparator | Eligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10. Receives: Other: Placebo; Biological: Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the ShigETEC vaccine in preventing shigellosis caused by the challenge strain
The proportion of participants with incidence of shigellosis caused by the challenge strain in vaccine vs. placebo recipients until the start of antibiotic administration.
Measured: Up to study day 60
Secondary outcomes (3)
Safety and tolerability of ShigETEC oral vaccine
- Number and severity of gastrointestinal and other solicited symptoms (specified as reactogenicity events) up to Day 16 (6 days after last vaccination)
- Number and severity of unsolicited AEs up to Day 60 (28 days after challenge)
- Number and severity of SAEs/MAAEs/pIMD up to Day 375 (12 months after last vaccination)
- Number and severity of AEs of special interest
Measured: Up to 12 months after last vaccination
Characterization of the challenge strain shedding in stool samples
Number and percentage of participants with detectable presence of challenge strain in stool samples detected by quantitative or qualitative culture or polymerase chain reaction (PCR).
Measured: Up to study day 40
Severity of disease following challenge using Shigella disease score
Maximum disease severity following challenge in the vaccinated vs placebo groups using the Shigella disease score.
Measured: Up to day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start30 Jun 2025 (estimated)
- Primary completion23 May 2027 (estimated)
- Study completion23 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShigellaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eveliqure Biotechnologies GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049159
- Sponsor's protocol ID
- EVQ2001 / DMID 23-0009
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-stage, Phase 2b, Randomized, Double-blind, Placebo-controlled Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old
- ClinicalTrials.gov ID
- NCT07049159
- Acronym / sponsor ID
- EVQ2001 / DMID 23-0009
- Conditions
- Shigella
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Eveliqure Biotechnologies GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 23 May 2027 (estimated)
- Study completion
- 23 May 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T.
In Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10^10 CFU. This dose was tested in a Phase 1 trial and found to be safe when given 4 times with an interval of 3 days between each dose.
The efficacy of ShigETEC vaccination will be evaluated in Stage 2 of this study, when participants will be challenged with S. flexneri 2457T.
The study population will be healthy adult participants in the age of 18-50 years (inclusive), which are clearly defined in the study protocol.
Detailed description
This is a two-stage, randomized, double blind, placebo-controlled Phase 2b study in healthy participants conducted at a single site.
The study will be conducted in two Stages (Stage 1 and Stage 2) and two arms in Stage 1 (Arm 1 and Arm 2).
Stage 1 Stage 1 will be conducted in an outpatient setting and includes the vaccination with the investigational product, ShigETEC, a live, attenuated, oral vaccine (Arm 1) and placebo (Arm 2) and subsequent follow-up.
Stage 2 Stage 2 will include an infectious challenge of selected Stage 1 participants in an inpatient setting (CHIM: Controlled Human Infection Model) in which participants will receive 1 oral dose of Shigella flexneri 2a 2457T and be followed closely for the signs and symptoms of shigellosis.
Stage 2 will start 21 (+5) days after the last dose of vaccine or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ShigETEC, a live, attenuated, oral vaccine | Experimental | Biological: ShigETEC vaccine, Biological: Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFUEligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10. |
| Placebo | Placebo comparator | Other: Placebo, Biological: Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFUEligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Generally healthy non-pregnant, non-nursing adults aged 18 to 50 years.
- Who are determined by medical history, physical examination, laboratory testing, and clinical judgment to be eligible for this study.
- Who provide written informed consent after the nature of the study had been explained.
- Who are available for the duration of the trial (from enrollment to study completion).
- Who are able to understand and are willing to comply with all study requirements, and willing to follow the instructions of the study staff and complete a comprehension test.
Key exclusion criteria (29 listed)
- Participants who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period.
- Presence of a significant medical or psychiatric condition which in the opinion of the Investigator precludes participation in the study.
- Clinically significant abnormalities in screening hematology or serum chemistry, defined as > grade 1 abnormality of serum potassium, alanine aminotransferase (ALT) or creatinine, hemoglobin, white blood cell count (WBC), or neutrophil count.
- Who have received any blood products, including immunoglobulin, in the period from 6 months prior to vaccination or are anticipated to receive such products through to the conclusion of the study and have not donated blood within 30 days and agree not to donate blood until 1 year after challenge.
- Who are receiving systemic antibiotics, completed antibiotic therapy, or receiving probiotics, prebiotics or synbiotics in previous 7 days before vaccination, or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing with vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShigETEC vaccineThe ShigETEC vaccine will be administered orally 4 times at 3-day intervals as a bacterial suspension in a volume of 30 mL per dose (target to contain 5x10^10 CFU) | Biological | ShigETEC, a live, attenuated, oral vaccine |
| PlaceboEligible participants will be randomly assigned in a 1:1 ratio to receive either ShigETEC 5x10^10 colony forming units (CFU) or placebo. Participants will receive their assigned treatment on Days 1, 4, 7, and 10. | Other | Placebo |
| Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFUIn the challenge stage all participants will receive 1 oral dose of Shigella flexneri 2457T at a dose of 1.5x10^3 CFU. | Biological | Placebo, ShigETEC, a live, attenuated, oral vaccine |
Primary outcome
Efficacy of the ShigETEC vaccine in preventing shigellosis caused by the challenge strain
Time frame: Up to study day 60
The proportion of participants with incidence of shigellosis caused by the challenge strain in vaccine vs. placebo recipients until the start of antibiotic administration.
3 secondary outcomes
Safety and tolerability of ShigETEC oral vaccine
Time frame: Up to 12 months after last vaccination
Characterization of the challenge strain shedding in stool samples
Time frame: Up to study day 40
Severity of disease following challenge using Shigella disease score
Time frame: Up to day 40
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ShigETEC vaccine and Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU in people with Shigella, run by Eveliqure Biotechnologies GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kawsar Talaat, MD (+1 410-955-7283, ktalaat@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the ShigETEC vaccine in preventing shigellosis caused by the challenge strain (time frame: Up to study day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.