Human Challenge Model With ST-only Enterotoxigenic Escherichia Coli

Status Recruiting

Clinical Trial Summary

Heat stable toxin (ST) producing ETEC strains are important causes of childhood diarrhea in many countries. Vaccine candidates targeting ST are in development. A human challenge model using an epidemiologically relevant enterotoxigenic E.coli (ETEC) strain expressing ST, but not other diarrhea inducing toxins like heat labile toxin (LT), is necessary to perform an early and efficient evaluation of an ST-toxoid based vaccine.

In this controlled human infection study the investigators will assess the safety of a ST-only producing ETEC strain and the dose needed to achieve an attack rate of 70% in healthy human volunteers.

Clinical Trial Description

The investigators have evaluated the ST-only ETEC strain TW10722 in volunteers previously, and will also evaluate the ETEC strain TW11681, an ETEC family 8, serotype O19:H45, expressing STh, CFA/I, and CS21. These strains have been selected because it is a good representative of one of the most important ETEC families commonly associated with childhood ETEC diarrhea. The TW10722 will also be evaluated at higher dose if TW11681 does not work well.

After screening including routine blood sampling, intestinal lavage and pre-challenge sampling will be done. Volunteers will then be admitted three at a time to Haukeland University Hospital and isolated before receiving the oral bacterial inoculum doses, starting with 10^6 and increasing one log per round until a safe dose that elicits diarrhoea is found. Fine adjustment of the dose needed for a diarrhea attack rate of 70% will then be done in the remaining volunteers. Volunteers will be monitored for a range of symptoms, stool output and adverse events.

Antibiotic treatment will be administered at certain predetermined severities of diarrheal disease, or after 5 days to eradicate the ETEC infection in all volunteers before leaving the hospital. Volunteers will be monitored and sampled again at day 10, 28 and 365 after infection. Serum, plasma, stool, intestinal lavage and PBMC samples will be obtained before, during and after the ETEC infection to evaluate immune responses and potential correlates of protection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02870751
Study type	Interventional
Source	University of Bergen
Contact	Kurt Hanevik, MD, PhD
Phone	+4793856690
Email	kurt.hanevik@med.uib.no
Status	Recruiting
Phase	Phase 1
Start date	May 2016
Completion date	September 2019

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT00732732` - A Controlled Trial of Plantain Powder in Infantile Diarrhea	N/A
Not yet recruiting	`NCT03598010` - Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea	N/A
Recruiting	`NCT04654832` - IVC Index in Patient With Diarrhea and Dehydration And How It Affects Its Management
Completed	`NCT04061538` - Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age	N/A
Completed	`NCT05322655` - PAthogen Transmission and Health Outcome Models of Enteric Disease
Completed	`NCT01345695` - Bihar Evaluation of Social Franchising and Telemedicine	N/A
Completed	`NCT04335877` - Effect of Prompting the Supply of Zinc/LO-ORS Co-packs in the Private Sector Plus BCI on Childhood Diarrhea Treatment	N/A
Active, not recruiting	`NCT03012048` - Effectiveness of Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in South Africa	N/A
Completed	`NCT04677296` - Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children	N/A
Completed	`NCT04209751` - Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA)
Completed	`NCT00447161` - Preventing Antibiotic-Associated DiarRhea Using Erceflora	Phase 4
Recruiting	`NCT05766826` - Coupons for Safe Water Project	N/A
Terminated	`NCT04628819` - Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children	N/A
Not yet recruiting	`NCT04528303` - Whole Genome Sequencing Versus Whole Exome Sequencing for Congenital Diarrhea and Enteropahty	N/A
Completed	`NCT03473561` - Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Human Challenge Model With ST-only Enterotoxigenic Escherichia Coli — ETECvacWP2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms