Clinical trials: Enterotoxigenic Escherichia Coli Infection
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
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
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
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
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
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
Healthy Volunteers
ShigETEC Vaccine Study in Bangladesh
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…
- Trial name
- NCT05987488
- Testing
- ShigETEC live, attenuated, oral vaccine
- Where
- Bangladesh
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
Gastroenteritis Escherichia Coli
Phase I Study of ETEC Vaccine
The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli infection) is safe. This vaccine will be tested to see what effects it has on the body and the ability of the vaccine to help the body…
- Trial name
- NCT01147445
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Escherichia Infection
Efficacy Study of IM Administered CssBA+dmLT Against Moderate-severe Diarrhea in Human Infection Model With ETEC Strain B7A in Healthy Adults
The study is designed to evaluate the safety, immunogenicity, and efficacy of the intramuscular administration of a CS6 based vaccine (CssBA) against ETEC co-administered with double mutant labile toxin (dmLT) in preventing…
- Trial name
- NCT06692907
- Testing
- B7A (ETEC challenge strain), CssBA, dmLT
- Where
- 2 sites in United States
- Volunteers
- 72 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)
Diarrhea
Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children
This is a randomized, double-blind, placebo-controlled clinical trial performed in Egyptian children 6-18 months of age. The primary aim of the study is to determine the protective efficacy of an oral, inactivated whole-cell…
- Trial name
- NCT02556996
- Testing
- ETEC/rCTB vaccine
- Volunteers
- 356 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
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
Diarrhea, Infantile
Human Challenge Model With ST-only Enterotoxigenic Escherichia Coli
Heat stable toxin (ST) producing ETEC strains are important causes of childhood diarrhea in many countries. Vaccine candidates targeting ST are in development.
- Trial name
- ETECvacWP2 (NCT02870751)
- Testing
- TW11681 or TW10722
- Where
- Norway
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Bergen
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
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
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.
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
Diarrhea
Dose-finding Study of WS6788A, DS37-4 and H10407 Enterotoxigenic Escherichia Coli (ETEC) Challenge Strains
Five subjects will be admitted to the General Clinical Research Center (GCRC). The next day they will eat a light breakfast, fast for 90 minutes, ingest ETEC strain H10407, and fast for 90 more minutes.
- Trial name
- NCT00198796
- Testing
- H10407
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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)