Diarrhea, InfantilePhase 1ETECvacWP2NCT02870751
Human Challenge Model With ST-only Enterotoxigenic Escherichia Coli
A Phase 1 study testing TW11681 or TW10722 in people with Diarrhea, Infantile, run by University of Bergen at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Infantile
- What is being tested?
- TW11681 or TW10722
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- May 2016to Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent before initiation of any study procedures.
- Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, and medication history.
- Within 15 days of vaccination, have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), C-reactive protein (CRP).
- Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 80 percent).
- Capable of understanding, consenting and complying with the entire study protocol.
- Female subjects must be of non-childbearing potential, (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential must be practicing abstinence or using an effective licensed method of birth control (e.g., history of hysterectomy or tubal ligation; use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), cervical sponges, diaphragms, condoms with spermicidal agents, or must have a vasectomized partner) within 2 months of infection and must agree to continue such precautions during the study and for 30 days after the Day 56 study visit. Male subjects must agree not to father a child for 90 days after the Day 28 study visit. A woman is eligible if she is monogamous with a vasectomized male.
- Agrees not to participate in another clinical trial during the study period.
Who cannot join
- Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test upon admission to inpatient facility.
- Abnormal Vital signs, defined as:
- Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days; or (heart rate <55 at rest on 2 separate days)
- Respiratory rate >17
- Temperature >/= 38.0 C (100.4 F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of inoculum.
- Active positive Hepatitis B, C, and Human Immunodeficiency Virus (HIV) serologies.
Show all 26Show fewer
- History of antimicrobial treatment in the 2 weeks before bacterial inoculum
- Received previous experimental E. coli, LT, or cholera vaccines or live E. coli or Vibrio cholerae challenges; or previous infection with cholera or diarrheagenic E. coli.
- Abnormal bowel habits as defined by fewer than 3 stools per week or more than 2 stools per day in the past 6 months.
- History of chronic gastrointestinal illness, including severe dyspepsia (mild or moderate heartburn or epigastric pain occurring no more than 3 times per week is permitted), lactose intolerance, or other significant gastrointestinal tract disease.
- Regular use (weekly or more often) of laxatives, anti-diarrheal, anti-constipation, or antacid therapy.
- History of major gastrointestinal surgery, excluding uncomplicated appendectomy or cholecystectomy.
- Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed).
- Have a diagnosis of schizophrenia or other major psychiatric diagnosis.
- Receiving the following psychiatric drugs: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate
- History of receiving immunoglobulin or other blood product within the 3 months before enrollment in this study.
- Traveled to Enterotoxigenic Escherichia coli (ETEC) endemic areas within the past 2 years, ever having used Cholera/ETEC vaccine (Dukoral) or having been raised in a cholera or ETEC endemic area.
- Received any licensed vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) before enrollment in this study.
- An acute or chronic medical condition that, in the opinion of the investigator, would render ETEC infection unsafe or would interfere with the evaluation of responses. This includes, but is not limited to: known or suspected immunodeficiency, known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, history of diabetes, cancer (other than a healed skin lesion), heart disease (in the hospital for a heart attack, history of irregular heart beat or fainting caused by an irregular heart beat), unconsciousness (other than a single brief "concussion"), seizures (other than with fever when subject was a child <5 years old), asthma requiring treatment with inhaler or medication in the prior 2 years, autoimmune disease or eating disorder, and transplant recipients.
- Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study.
- History of alcohol or drug abuse in the last 5 years.
- Planned to travel abroad in the time between vaccination and 30 days following the ETEC inoculum dose.
- Any condition that would, in the opinion of the Site Investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Use of prescription and over-the-counter (OTC) medications that contain acetaminophen, aspirin, ibuprofen, and other nonsteroidal anti-inflammatory drugs within 48 hours prior to receiving the investigational product.
- Use of prescription acid suppression medication or OTC antacids within 72 hours of investigational product administration.
- Subjects with autoimmune disorders, chronic inflammatory disorders or neurological disorders with a potential autoimmune correlation.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Hordaland, 5021
Kurt Hanevik, MD, PhD, +47 9385690, kurt.hanevik@med.uib.no
About this study
Official title: Developing A Human Challenge Model For Evaluating Vaccines Against ST-producing 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. 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.
Read the detailed 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.
- Conditions
- Diarrhea, Infantile
- Being tested
- TW11681 or TW10722
- Keywords
- ETEC, human challenge study, heat stable toxin, tourist diarrhea, diarrhea, enterotoxigenic
- Medical subject headings
- Diarrhea, Infantile, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TW11681 or TW10722Biological
| Study group | Role | What they receive |
|---|---|---|
| ST-only ETEC strain TW11681 or TW10722 | Experimental | Oral inoculum of several doses of bacteria to establish range to achieve diarrhea attack rate in around 70% of volunteers. Receives: Biological: TW11681 or TW10722 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrheal disease
Measured: 5 days
Adverse event monitoring
Measured: 30 days
Secondary outcomes (1)
Immune responses towards challenge strain
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diarrhea, InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Haukeland University Hospital
- Responsible party
- Principal investigator, Kurt Hanevik, University of Bergen
- Investigators
- Halvor Sommerfelt, MD, PhD, Study chair, Centre for International Health, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870751
- Sponsor's protocol ID
- NRC234364
- Acronym
- ETECvacWP2
- Status last verified
- Sep 2018
- First submitted
- 13 Aug 2016
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data and samples may be shared with current and future partners
Publications
Skrede S, Steinsland H, Sommerfelt H, Aase A, Brandtzaeg P, Langeland N, Cox RJ, Saevik M, Wallevik M, Skutlaberg DH, Tellevik MG, Sack DA, Nataro JP, Guttormsen AB. Experimental infection of healthy volunteers with enterotoxigenic Escherichia coli wild-type strain TW10598 in a hospital ward. BMC Infect Dis. 2014 Sep 4;14:482. doi: 10.1186/1471-2334-14-482.
PubMed 25190096Aase A, Sommerfelt H, Petersen LB, Bolstad M, Cox RJ, Langeland N, Guttormsen AB, Steinsland H, Skrede S, Brandtzaeg P. Salivary IgA from the sublingual compartment as a novel noninvasive proxy for intestinal immune induction. Mucosal Immunol. 2016 Jul;9(4):884-93. doi: 10.1038/mi.2015.107. Epub 2015 Oct 28.
PubMed 26509875Sahl JW, Steinsland H, Redman JC, Angiuoli SV, Nataro JP, Sommerfelt H, Rasko DA. A comparative genomic analysis of diverse clonal types of enterotoxigenic Escherichia coli reveals pathovar-specific conservation. Infect Immun. 2011 Feb;79(2):950-60. doi: 10.1128/IAI.00932-10. Epub 2010 Nov 15.
PubMed 21078854Steinsland H, Lacher DW, Sommerfelt H, Whittam TS. Ancestral lineages of human enterotoxigenic Escherichia coli. J Clin Microbiol. 2010 Aug;48(8):2916-24. doi: 10.1128/JCM.02432-09. Epub 2010 Jun 9.
PubMed 20534806Rim S, Sakkestad ST, Zhou F, Gullaksen SE, Skavland J, Chauhan SK, Steinsland H, Hanevik K. Dynamics of circulating lymphocytes responding to human experimental enterotoxigenic Escherichia coli infection. Eur J Immunol. 2023 Aug;53(8):e2250254. doi: 10.1002/eji.202250254. Epub 2023 Jun 28.
PubMed 37102399Sakkestad ST, Steinsland H, Skrede S, Lillebo K, Skutlaberg DH, Guttormsen AB, Zavialov A, Paavilainen S, Soyland H, Saevik M, Heien AR, Tellevik MG, Barry E, Langeland N, Sommerfelt H, Hanevik K. A new human challenge model for testing heat-stable toxin-based vaccine candidates for enterotoxigenic Escherichia coli diarrhea - dose optimization, clinical outcomes, and CD4+ T cell responses. PLoS Negl Trop Dis. 2019 Oct 30;13(10):e0007823. doi: 10.1371/journal.pntd.0007823. eCollection 2019 Oct.
PubMed 31665141
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing A Human Challenge Model For Evaluating Vaccines Against ST-producing Enterotoxigenic Escherichia Coli
- ClinicalTrials.gov ID
- NCT02870751
- Acronym / sponsor ID
- ETECvacWP2 / NRC234364
- Conditions
- Diarrhea, Infantile
- Keywords
- ETEC, human challenge study, heat stable toxin, tourist diarrhea, diarrhea, enterotoxigenic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- University of Maryland, Haukeland University Hospital
- Study start
- May 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ST-only ETEC strain TW11681 or TW10722 | Experimental | Biological: TW11681 or TW10722Oral inoculum of several doses of bacteria to establish range to achieve diarrhea attack rate in around 70% of volunteers. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provide written informed consent before initiation of any study procedures.
- Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, and medication history.
- Within 15 days of vaccination, have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), C-reactive protein (CRP).
- Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 80 percent).
- Capable of understanding, consenting and complying with the entire study protocol.
Key exclusion criteria (26 listed)
- Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test upon admission to inpatient facility.
- Abnormal Vital signs, defined as:
- Active positive Hepatitis B, C, and Human Immunodeficiency Virus (HIV) serologies.
- History of antimicrobial treatment in the 2 weeks before bacterial inoculum
- Received previous experimental E. coli, LT, or cholera vaccines or live E. coli or Vibrio cholerae challenges; or previous infection with cholera or diarrheagenic E. coli.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TW11681 or TW10722 | Biological | ST-only ETEC strain TW11681 or TW10722 |
Primary outcome
Diarrheal disease
Time frame: 5 days
Adverse event monitoring
Time frame: 30 days
1 secondary outcome
Immune responses towards challenge strain
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Background: PubMed 25190096Skrede S, Steinsland H, Sommerfelt H, Aase A, Brandtzaeg P, Langeland N, Cox RJ, Saevik M, Wallevik M, Skutlaberg DH, Tellevik MG, Sack DA, Nataro JP, Guttormsen AB. Experimental infection of healthy volunteers with enterotoxigenic Escherichia coli wild-type strain TW10598 in a hospital ward. BMC Infect Dis. 2014 Sep 4;14:482. doi: 10.1186/1471-2334-14-482.
- Background: PubMed 26509875Aase A, Sommerfelt H, Petersen LB, Bolstad M, Cox RJ, Langeland N, Guttormsen AB, Steinsland H, Skrede S, Brandtzaeg P. Salivary IgA from the sublingual compartment as a novel noninvasive proxy for intestinal immune induction. Mucosal Immunol. 2016 Jul;9(4):884-93. doi: 10.1038/mi.2015.107. Epub 2015 Oct 28.
- Background: PubMed 21078854Sahl JW, Steinsland H, Redman JC, Angiuoli SV, Nataro JP, Sommerfelt H, Rasko DA. A comparative genomic analysis of diverse clonal types of enterotoxigenic Escherichia coli reveals pathovar-specific conservation. Infect Immun. 2011 Feb;79(2):950-60. doi: 10.1128/IAI.00932-10. Epub 2010 Nov 15.
- Background: PubMed 20534806Steinsland H, Lacher DW, Sommerfelt H, Whittam TS. Ancestral lineages of human enterotoxigenic Escherichia coli. J Clin Microbiol. 2010 Aug;48(8):2916-24. doi: 10.1128/JCM.02432-09. Epub 2010 Jun 9.
- Derived from this study: PubMed 37102399Rim S, Sakkestad ST, Zhou F, Gullaksen SE, Skavland J, Chauhan SK, Steinsland H, Hanevik K. Dynamics of circulating lymphocytes responding to human experimental enterotoxigenic Escherichia coli infection. Eur J Immunol. 2023 Aug;53(8):e2250254. doi: 10.1002/eji.202250254. Epub 2023 Jun 28.
- Derived from this study: PubMed 31665141Sakkestad ST, Steinsland H, Skrede S, Lillebo K, Skutlaberg DH, Guttormsen AB, Zavialov A, Paavilainen S, Soyland H, Saevik M, Heien AR, Tellevik MG, Barry E, Langeland N, Sommerfelt H, Hanevik K. A new human challenge model for testing heat-stable toxin-based vaccine candidates for enterotoxigenic Escherichia coli diarrhea - dose optimization, clinical outcomes, and CD4+ T cell responses. PLoS Negl Trop Dis. 2019 Oct 30;13(10):e0007823. doi: 10.1371/journal.pntd.0007823. eCollection 2019 Oct.
- Individual participant dataSharing planned: Yes. Data and samples may be shared with current and future partners
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halvor Sommerfelt, MD, PhD study chair
Centre for International Health, University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TW11681 or TW10722 in people with Diarrhea, Infantile, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kurt Hanevik, MD, PhD (+4793856690, kurt.hanevik@med.uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrheal disease (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02870751, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.