DiarrheaPhase 2TrekNCT00516659
ETEC Logistics Trial (TREK)
A Phase 2 study testing Heat-Labile Enterotoxin of Escherichia coli (LT) in people with Diarrhea, run by Intercell USA, Inc. at 19 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Heat-Labile Enterotoxin of Escherichia coli (LT)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 19 sitesin 3 countries
- Study dates
- May 2006to Dec 2007
- Phase
- Phase 2
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult men and women 18-64 years of age inclusive at screening
- Signed Informed Consent form
- Planned travel to an area within 2 ½ hours traveling distance of Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala (minimum stay of 7 days)
- If female who is not post-menopausal or surgically sterile, negative pregnancy test (within 24 hours prior to vaccination) and agreement to employ an effective form of birth control or practice abstinence through the end of the study.
Who cannot join
- Clinically significant abnormalities as determined by the Investigator/clinician during physical inspection
- Received investigational product from 30 days before date of first vaccination or during the entire study period
- Ever received LT, ETEC, or cholera vaccine
- History of traveler's diarrhea within the previous year
- Travel to a developing country within the last year
- Women who are pregnant or breastfeeding
Show all 15Show fewer
- History of achlorhydria
- Evidence of immunosuppression, including concomitant immunosuppressive therapy; fever > 99.5°F (37.5°C) on day of vaccination
- Current problems with alcohol or substance abuse
- An employee of the study clinic
- Sensitivity or allergy to any of the vaccine components
- History of significant blood loss, blood product donation, or blood product recipient in the previous 60 days
- Planned use of Imodium or antibiotics for self treatment of diarrhea during the study period
- Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; and
- Medical history of acute or chronic GI illness or major GI surgery.
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United States13 sites
Johns Hopkins University, Bloomberg School of Public Health
Baltimore, Maryland, 21205
Radiant Research
Chicago, Illinois, 60610
Radiant Research
Columbus, Ohio, 43212
Radiant Research
Dallas, Texas, 75235
Advanced Biomedical Research
Hackensack, New Jersey, 07601
Breco Research
Houston, Texas, 77024
Center for Infectious Diseases, The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Asthma Allergy & Associates
Ithica, New York, 14850
West Coast Clinical Trials
Long Beach, California, 90806
Twin Cities Clinical Research
Minneapolis, Minnesota, 55430
Jean Brown Research
Salt Lake City, Utah, 84124
Radiant Research
San Antonio, Texas, 78229
Northwest Kinetics
Tacoma, Washington, 98418
Mexico5 sites
Hospital Americano
Cancún, Quintana Roo, 77500
Private Clinic Cuernavaca
Cuernavaca, Morelos, 62250
Private Clinic Guadalajara
Guadalajara, Jalisco, 44690
AmeriMed Hospital
Puerto Vallarta, Marina Vallarta, 48334
Private Clinic San Miguel
San Miguel de Allende, Guanajuata, 37700
About this study
Official title: A Phase II, Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Epidemiology of Natural Infection With Enterotoxigenic Escherichia Coli Occurring After Transcutaneous Immunization in a Field Setting
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.
Read the detailed description
The primary objectives of the study are to evaluate the incidence of ETEC illness in a field setting and to compare the safety of LT delivered by TCI with placebo. The secondary objectives include, but are not limited to:
evaluate the stool frequency per episode of ETEC illness in placebo recipients, to evaluate the immunogenicity of LT delivered by TCI, to evaluate the incidence of IBS following travel to areas of ETEC endemnicity, and to evaluate the incidence of VPO in placebo and LT patch recipients.
- Conditions
- Diarrhea
- Being tested
- Heat-Labile Enterotoxin of Escherichia coli (LT), Placebo
- Keywords
- ETEC, Traveler's diarrhea, TCI, patch vaccine, diarrhea prevention, epidemiology ETEC, Escherichia coli
- Medical subject headings
- Diarrhea, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat-Labile Enterotoxin of Escherichia coli (LT)Biological
Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.
PlaceboBiological
The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 37.5µg LT Receives: Biological: Heat-Labile Enterotoxin of Escherichia coli (LT) |
| Group 2 | Placebo comparator | Group 2 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 0µg LT (placebo patch containing no LT) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Enterotoxigenic Escherichia coli (ETEC) illness defined as a diarrheal episode associated with an LT, LT/ST, or ST-positive ETEC strain isolated from a sample of a stool
Measured: during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
Safety of heat-labile enterotoxin of Escherichia coli (LT) delivered by transcutaneous immunization (TCI) vs placebo
Measured: From vaccination 1 to completion of Day 180 follow-up, about a seven month time period
Secondary outcomes (4)
Stool frequency per episode of ETEC illness in placebo recipients
Measured: Duration of stay in Mexico or Guatemala assessed up to four weeks
Immunogenicity of LT delivered by TCI
Measured: at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
Incidence of irritable bowel syndrome following travel to areas of ETEC endemnicity.
Measured: Baseline through six months post return from Latin America. A period of about six months.
Incidence of vaccine preventable outcome in placebo and LT patch recipients.
Measured: Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startMay 2006
- Primary completionJan 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies 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 2
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intercell USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert L. DuPont, MD, Principal investigator, Center for Infectious Diseases, The University of Texas Health Science Center at HoustonRobin McKenzie, MD, Principal investigator, Johns Hopkins University, Bloomberg School of Public HealthRama Yerramsetti, Principal investigator, Breco Research, Houston, TXWilliam P Jennings, Principal investigator, Radiant Research, San Antonio, TXYu-Luen Hsu, Principal investigator, West Coast Clinical Trials, Long Beach, CAChristopher A Smith, Principal investigator, Asthma & Allergy Associates, Ithaca, NYBenno G Roesch, Principal investigator, Advanced Biomedical Research, Hackensack, NJJeffrey G Geohas, Principal investigator, Radiant Research, Chicago, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516659
- Sponsor's protocol ID
- ELT206
- Acronym
- Trek
- Status last verified
- Mar 2012
- First submitted
- 13 Aug 2007
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Frech SA, Dupont HL, Bourgeois AL, McKenzie R, Belkind-Gerson J, Figueroa JF, Okhuysen PC, Guerrero NH, Martinez-Sandoval FG, Melendez-Romero JH, Jiang ZD, Asturias EJ, Halpern J, Torres OR, Hoffman AS, Villar CP, Kassem RN, Flyer DC, Andersen BH, Kazempour K, Breisch SA, Glenn GM. Use of a patch containing heat-labile toxin from Escherichia coli against travellers' diarrhoea: a phase II, randomised, double-blind, placebo-controlled field trial. Lancet. 2008 Jun 14;371(9629):2019-25. doi: 10.1016/S0140-6736(08)60839-9.
PubMed 18554712
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Epidemiology of Natural Infection With Enterotoxigenic Escherichia Coli Occurring After Transcutaneous Immunization in a Field Setting
- ClinicalTrials.gov ID
- NCT00516659
- Acronym / sponsor ID
- Trek / ELT206
- Conditions
- Diarrhea
- Keywords
- ETEC, Traveler's diarrhea, TCI, patch vaccine, diarrhea prevention, epidemiology ETEC, Escherichia coli
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Intercell USA, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Aug 2007 (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.
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.
Detailed description
The primary objectives of the study are to evaluate the incidence of ETEC illness in a field setting and to compare the safety of LT delivered by TCI with placebo. The secondary objectives include, but are not limited to:
evaluate the stool frequency per episode of ETEC illness in placebo recipients, to evaluate the immunogenicity of LT delivered by TCI, to evaluate the incidence of IBS following travel to areas of ETEC endemnicity, and to evaluate the incidence of VPO in placebo and LT patch recipients.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: Heat-Labile Enterotoxin of Escherichia coli (LT)Group 1 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 37.5µg LT |
| Group 2 | Placebo comparator | Biological: PlaceboGroup 2 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 0µg LT (placebo patch containing no LT) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult men and women 18-64 years of age inclusive at screening
- Signed Informed Consent form
- Planned travel to an area within 2 ½ hours traveling distance of Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala (minimum stay of 7 days)
- If female who is not post-menopausal or surgically sterile, negative pregnancy test (within 24 hours prior to vaccination) and agreement to employ an effective form of birth control or practice abstinence through the end of the study.
Key exclusion criteria (15 listed)
- Clinically significant abnormalities as determined by the Investigator/clinician during physical inspection
- Received investigational product from 30 days before date of first vaccination or during the entire study period
- Ever received LT, ETEC, or cholera vaccine
- History of traveler's diarrhea within the previous year
- Travel to a developing country within the last year
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 |
|---|---|---|
| Heat-Labile Enterotoxin of Escherichia coli (LT)Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart. | Biological | Group 1 |
| PlaceboThe placebo patch contains all of the components of the active patch, but with no LT included in the formulation. | Biological | Group 2 |
Primary outcome
Incidence of Enterotoxigenic Escherichia coli (ETEC) illness defined as a diarrheal episode associated with an LT, LT/ST, or ST-positive ETEC strain isolated from a sample of a stool
Time frame: during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
Safety of heat-labile enterotoxin of Escherichia coli (LT) delivered by transcutaneous immunization (TCI) vs placebo
Time frame: From vaccination 1 to completion of Day 180 follow-up, about a seven month time period
4 secondary outcomes
Stool frequency per episode of ETEC illness in placebo recipients
Time frame: Duration of stay in Mexico or Guatemala assessed up to four weeks
Immunogenicity of LT delivered by TCI
Time frame: at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
Incidence of irritable bowel syndrome following travel to areas of ETEC endemnicity.
Time frame: Baseline through six months post return from Latin America. A period of about six months.
Incidence of vaccine preventable outcome in placebo and LT patch recipients.
Time frame: Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
- Derived from this study: PubMed 18554712Frech SA, Dupont HL, Bourgeois AL, McKenzie R, Belkind-Gerson J, Figueroa JF, Okhuysen PC, Guerrero NH, Martinez-Sandoval FG, Melendez-Romero JH, Jiang ZD, Asturias EJ, Halpern J, Torres OR, Hoffman AS, Villar CP, Kassem RN, Flyer DC, Andersen BH, Kazempour K, Breisch SA, Glenn GM. Use of a patch containing heat-labile toxin from Escherichia coli against travellers' diarrhoea: a phase II, randomised, double-blind, placebo-controlled field trial. Lancet. 2008 Jun 14;371(9629):2019-25. doi: 10.1016/S0140-6736(08)60839-9.
- Related InfoLink provided by the sponsor.
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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.
Herbert L. DuPont, MD principal investigator
Center for Infectious Diseases, The University of Texas Health Science Center at Houston
Robin McKenzie, MD principal investigator
Johns Hopkins University, Bloomberg School of Public Health
Rama Yerramsetti principal investigator
Breco Research, Houston, TX
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Heat-Labile Enterotoxin of Escherichia coli (LT) in people with Diarrhea, run by Intercell USA, Inc. at 19 sites in 3 countries.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Mexico, Guatemala. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Enterotoxigenic Escherichia coli (ETEC) illness defined as a diarrheal episode associated with an LT, LT/ST, or ST-positive ETEC strain isolated from a sample of a stool (time frame: during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.). 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 NCT00516659, which also lists 1 linked publication.
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 14 Mar 2012.