Clinical trials: Enterotoxigenic E. Coli (ETEC) Infection
Gastroenteritis Escherichia Coli, Immunisation
A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area
This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in approximately 135…
- Trial name
- NCT03548064
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteer
Human Challenge Model Refinement With Enterotoxigenic Escherichia Coli Strain B7A
The purpose of this study is to determine the safe and optimal dose and regimen (fasting duration) for administering the challenge ETEC strain B7A, a CS6 expressing ETEC strain.
- Trial name
- NCT02773446
- Testing
- ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Enterotoxigenic Escherichia Coli Infection, Diarrhea
Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701
This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge study designed to confirm a human challenge model with E. coli strain LSN03-016011/A.
- Trial name
- NCT03576183
- Testing
- VLA1701, Challenge Strain
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Healthy Volunteer
Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers.
- Trial name
- NCT03040687
- Testing
- Anti CS6 BSIgG product (Lot PD1601105CS), Anti B7A BSIgG product (Lot PD1601132ET), Bovine Immunoglobin Negative Control (Lot PD161071NC)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Diarrhea
Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)
This study will evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin (dmLT) given by intramuscular (IM) injection.
- Trial name
- NCT03404674
- Testing
- CssBA, dmLT
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- PATH
Diarrhea, Travelers Diarrhea
Clinical Study to Assess the Efficacy of Once-daily IMM-124E (Travelan®) in a Controlled Human Infection Model.
This is a randomized, double-blind, placebo-controlled study to investigate a single daily dose of Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli…
- Conditions
- Diarrhea, Travelers Diarrhea, Infectious Diarrhea
- Trial name
- NCT05933525
- Testing
- Travelan
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Immuron Ltd.
Escherichia Coli Diarrhea
Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh
The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.
- Trial name
- ETVAX/dmLT (NCT02531802)
- Testing
- ETVAX, dmLT, Bicarbonate Buffer
- Where
- Bangladesh
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- PATH
Healty Volunteers, Preventable Disease, Vaccine
A Phase 2 Bridging Study to Assess the New Formulation of ETVAX
This is a phase 2,prospective double-blind, randomized, parallel-group study with the aim to demonstrate non-inferiority, in terms of immunogenicity, between the wet formulation and a newly developed partially dried formulation…
- Trial name
- NCT05178134
- Testing
- Etvax
- Where
- Sweden
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Scandinavian Biopharma AB
Polio
Inactivated Poliovirus Vaccine (IPV) With or Without E.Coli Double Mutant Heat-Labile Toxin (dmLT) Challenge Study in Healthy Adults
In this study, the safety and tolerability of inactivated polio vaccine (IPV) co-administered with dmLT will be assessed, as well as whether co-administration of dmLT with IPV enhances mucosal responses compared to those with IPV…
- Trial name
- NCT04232943
- Testing
- Inactivated Poliomyelitis Vaccine (IPV), E.coli Double Mutant Heat-Labile Toxin (dmLT) (adjuvant), Bivalent Oral Polio Vaccine (bOPV)
- Where
- Belgium
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- PATH
Escherichia Coli Infection
Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea
The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.
- Trial name
- NCT01644565
- Testing
- Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5, Recombinant fimbrial adhesin dscCfaE, Modified E. coli heat labile enterotoxin LTR192G
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Shigella Infection, Enterotoxigenic Escherichia Coli Infection
Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122
The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic.
- Trial name
- NCT04634513
- Testing
- strain CVD 1208S-122
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore