Clinical trials: Enterotoxigenic E. Coli (ETEC) Infection
Diarrhea
Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC)
This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of ETVAX.
- Trial name
- NCT03729219
- Testing
- E. coli ETVAX
- Where
- Finland
- Volunteers
- 749 people, healthy volunteers welcome
- Sponsor
- Scandinavian Biopharma AB
Diarrhea
The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection
The existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, targeted to impact on the immediate clinical symptoms upon E. coli infection.
- Trial name
- MIRRE (NCT03596827)
- Testing
- E. coli strain E1392-75-2A dose 1E10 CFU, E. coli strain E1392-75-2A dose 1E9 CFU, E. coli strain E1392-75-2A dose 1E8 CFU
- Where
- Netherlands
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- NIZO Food Research
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
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
Diarrhea Infectious
Study in Healthy Adults Challenged With Enterotoxigenic E. Coli, of the Safety, Tolerability and Anti-Diarrheal Activity of VENBETA6890, an Orally Administered, Human Monoclonal IgA
This is a phase 1, randomized, placebo-controlled, blinded study in up to 36 healthy adults, aged 18-45 years, challenged with Enterotoxigenic Escherichia coli, evaluating the safety, tolerability and anti-diarrheal activity of…
- Trial name
- MBL-ETEC-21-01 (NCT06896136)
- Testing
- VENBETA6890
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mark Klempner
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
Enteritis; Escherichia Coli, Enterotoxigenic
Challenge Study of an ETEC Vaccine
The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E. coli (ETEC)-caused diarrhea.
- Trial name
- NCT01922856
- Testing
- LTR192G with dscCfaE, No Intervention
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Gastroenteritis Escherichia Coli
Phase 1 Study of dmLT ID Vaccination in Healthy Adults
This study is to determine the safety and immunogenicity of an Enterotoxigenic Escherichia coli (ETEC) candidate vaccine, attenuated recombinant Double Mutant Heat-Labile Toxin (dmLT) from ETEC, administered by the Intradermal…
- Trial name
- NCT02531685
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gastroenteritis Escherichia Coli
Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult Subjects
Enterotoxigenic Escherichia (E.) coli (ETEC) bacteria are the main cause of traveler's diarrhea and are significant pathogens affecting children and elderly individuals of developing countries.
- Trial name
- NCT00654108
- Testing
- Ciprofloxacin, Peru-15-pCTB, Sodium bicarbonate/Ascorbic Acid/Aspartame Buffer
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Gastroenteritis Escherichia Coli
Safety of Sublingual dmLT for ETEC
A Phase 1 dose escalating study of ETEC candidate vaccine to determine safety and immunogenicity of a multi-dose regimen in healthy adult volunteers.
- Trial name
- NCT02052934
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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.
Polio
Evaluation of Safety, Reactogenicity and Immunogenicity of Fractional-dose Inactivated Polio Vaccine (fIPV) Given Intradermally With Double Mutant Enterotoxigenic Escherichia Coli Heat Labile Toxin (dmLT) Adjuvant
Polio is a serious disease that can cause paralysis and death. It is caused by a virus and can be prevented by vaccine. The World Health Organization's (WHO) Global Polio Eradication Initiative is trying to get rid of all polio…
- Trial name
- NCT03922061
- Testing
- dmLT, fIPV
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- University of Vermont
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
Diarrhea
ETEC Logistics Trial (TREK)
This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate the epidemiology of natural infection with ETEC occurring after transcutaneous immunization in a field setting.
- Trial name
- Trek (NCT00516659)
- Testing
- Heat-Labile Enterotoxin of Escherichia coli (LT)
- Where
- 19 sites in United States, Guatemala and 1 more
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Intercell USA, Inc.
Dysentery
Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections
The aim of this study is to accelerate the development of vaccine candidates against diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC).
- Trial name
- NCT01638039
- Testing
- Laboratory Tests
- Where
- 7 sites in Israel
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Hillel Yaffe Medical Center
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)
Enterotoxigenic E. Coli (ETEC) Infection
ACE527 Safety and Immunogenicity Study
The purpose of this study is to evaluate the safety and immune response to ACE527.
- Trial name
- NCT00901654
- Testing
- ACE527 vaccine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- TD Vaccines A/S
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
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
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