Recruiting PHASE2 Shigella

Tests treatment safety and results for Shigella

Official title 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

What this study is testing

What is ShigETEC vaccine?

ShigETEC vaccine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for shigella.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T.

Phase 2: a mid-size study of how well it works
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 50. Healthy volunteers may be eligible.

You may be able to join if

for stage 1:
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).

You likely can't join if

for stage 1:
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...
Who have received any blood products, including immunoglobulin, in the period from 6 months prior to vaccination or are anticipated to receive such...
Who are receiving systemic antibiotics, completed antibiotic therapy, or receiving probiotics, prebiotics or synbiotics in previous 7 days before...

See the full eligibility criteria

Who can join

for stage 1:
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.
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...
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.

What rules you out

for stage 1:
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...
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...
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...
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.
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...
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. Inclusion / Exclusion criteria...
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.

The study team makes the final eligibility decision.

Where it's taking place

Baltimore, Maryland, United States

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.