Travelers' DiarrheaPhase 3NCT00993681
Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
A Phase 3 study testing TD Vaccine System in people with Travelers' Diarrhea, run by Intercell USA, Inc. at 20 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease 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
- Travelers' Diarrhea
- What is being tested?
- TD Vaccine System
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,036 participants
- Where
- 20 sitesin 4 countries
- Study dates
- Oct 2009to Apr 2011
- Phase
- Phase 3
- 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
- 18-64 years of age at date of first vaccination
- Good health as determined by medical history and physical inspection
- Females of child-bearing potential must have a negative pregnancy test prior to first vaccination in teh Country of Origin; females of child-bearing potential must agree not to become pregnant throughout the duration of the study
- Subjects must have planned travel to an area within 3 hours traveling distance of Mexico City, Cuernavaca, Guadalajara, Oaxaca, or San Miguel de Allende, Mexico or Antigua, Quezaltenango, Guatemala City, or Solola, Guatemala for a minimum duration of stay 7 days (no maximum stay is specified for inclusion).
- Subject must be able to communicate in English
Who cannot join
- Abnormalities as determined by the Investigator/clinician during physical inspection
- Participated in research involving investigational product within 30 days before planned date of first vaccination
- Ever received LT, ETEC, or cholera vaccine
- History of diarrhea while traveling to a developing country within the last year
- Women who are pregnant or breastfeeding
- Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease
Show all 16Show fewer
- History of Irritable Bowel Syndrome
- Seizure disorder within the last year
- Current use of immunosuppressive therapy (excluding inhaled steroids) or current immunodeficiency
- Known or suspected alcohol abuse or illicit drug use within the last year
- Medical history of HIV, HBV, or HCV
- An employee of a study site
- Known allergies to any component of the vaccine, including adhesives
- Planned use of antibiotics with known activity against gram negative facultative anaerobes
- Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar during the surveillance phase of the study
- An employee of Intercell (global) or an immediate family member
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United Kingdom7 sites
Bio-Kinetic Europe Ltd
Belfast, Northern Ireland, BT2 7 BA
Synexus Lancashire Clinical Research Center
Chorley, Lancashire, PR7 7NA
Synexus Midlands Clinical Research Center
Edgbaston, Birmingham, B15 2SQ
Synexus Scotland Clinical Research Center
Glasgow, Scottland, G81 2DR
Hospital for Tropical Diseases
London, London, WC1E 6JB
Guy's Drug Research Unit
London Bridge, London, SE1 1YR
Synexus Thames Valley Clinical Research Center
Reading, Berkshire, RG2 0TG
Mexico5 sites
Internal Medicine Trek Study Cuernavaca
Cuernavaca, Morelos, 62250
Consultorio Privado Torre Medica San Javier
Guadalajara, Jalisco, 44670
Mexican Institute of Clinical Research (IMIC)
Mexico City, Mexico City, 06700
Hospital Reforma
Oaxaca City, Oaxaca, 68000
Roberto Maxwell's Office
San Miguel de Allende, Guanajuato, 37700
Germany4 sites
Berliner Centrum Reise & Tropenmedizin
Berlin, State of Berlin, 10117
University Medical Centre Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20359
Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin
München, Munchen, 80802
Klinik for Gastroenterologie & Infektiologie
Potsdam, Potsdam, 14467
Guatemala4 sites
Trek Study Antigua
Antigua, Departamento de Guatemala, 03001
Isthmian Medical Research Guatemala S.A.
Guatemala City, Departamento de Guatemala, 01015
Consultorio Privado
Quetzaltenango, Quezaltenango CP, 09001
SAMI-SSAPFORFAM Consultorio Privado
Sololá, Departamento de Sololá, 07001
About this study
Official title: A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System
The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease in a field setting.
- Conditions
- Travelers' Diarrhea
- Being tested
- TD Vaccine System
- Keywords
- Prevention of Travelers' Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD Vaccine SystemBiological
heat labile enterotoxin of E. coli (LT)
TD Vaccine SystemBiological
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 900 subjects will receive a two vaccination regimen with an LT patch Receives: Biological: TD Vaccine System |
| 2 | Placebo comparator | 900 subjects will receive a two vaccination regimen with a placebo patch Receives: Biological: TD Vaccine System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cases with vaccine preventable outcome
Measured: Day 17 (17 days after arrival in destination country)
Secondary outcomes (3)
The incidence of moderate/severe diarrhea
Measured: Day 17 (17 days after arrival in destination country)
Total unformed stool frequency from diarrheal episodes
Measured: Day 17 (17 days after arrival in destination country)
Total duration of diarrheal episodes
Measured: Day 17 (17 days after arrival in destination country)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2010
- Study completionApr 2011
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 Travelers' 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,036 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 Sciences Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993681
- Sponsor's protocol ID
- ELT301
- Other IDs
- EudraCT Number: 2008-008726-75
- Status last verified
- Mar 2012
- First submitted
- 8 Oct 2009
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Behrens RH, Cramer JP, Jelinek T, Shaw H, von Sonnenburg F, Wilbraham D, Weinke T, Bell DJ, Asturias E, Pauwells HL, Maxwell R, Paredes-Paredes M, Glenn GM, Dewasthaly S, Stablein DM, Jiang ZD, DuPont HL. Efficacy and safety of a patch vaccine containing heat-labile toxin from Escherichia coli against travellers' diarrhoea: a phase 3, randomised, double-blind, placebo-controlled field trial in travellers from Europe to Mexico and Guatemala. Lancet Infect Dis. 2014 Mar;14(3):197-204. doi: 10.1016/S1473-3099(13)70297-4. Epub 2013 Nov 29.
PubMed 24291168
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 Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System
- ClinicalTrials.gov ID
- NCT00993681
- Acronym / sponsor ID
- ELT301
- Conditions
- Travelers' Diarrhea
- Keywords
- Prevention of Travelers' Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,036 participants (actual)
- Lead sponsor
- Intercell USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 Oct 2009 (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.
The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease in a field setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: TD Vaccine System900 subjects will receive a two vaccination regimen with an LT patch |
| 2 | Placebo comparator | Biological: TD Vaccine System900 subjects will receive a two vaccination regimen with a placebo patch |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-64 years of age at date of first vaccination
- Good health as determined by medical history and physical inspection
- Females of child-bearing potential must have a negative pregnancy test prior to first vaccination in teh Country of Origin; females of child-bearing potential must agree not to become pregnant throughout the duration of the study
- Subjects must have planned travel to an area within 3 hours traveling distance of Mexico City, Cuernavaca, Guadalajara, Oaxaca, or San Miguel de Allende, Mexico or Antigua, Quezaltenango, Guatemala City, or Solola, Guatemala for a minimum duration of stay 7 days (no maximum stay is specified for inclusion).
- Subject must be able to communicate in English
Key exclusion criteria (16 listed)
- Abnormalities as determined by the Investigator/clinician during physical inspection
- Participated in research involving investigational product within 30 days before planned date of first vaccination
- Ever received LT, ETEC, or cholera vaccine
- History of diarrhea while traveling to a developing country within the last year
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| TD Vaccine Systemheat labile enterotoxin of E. coli (LT) | Biological | 1 |
| TD Vaccine Systemplacebo | Biological | 2 |
Primary outcome
Incidence of cases with vaccine preventable outcome
Time frame: Day 17 (17 days after arrival in destination country)
3 secondary outcomes
The incidence of moderate/severe diarrhea
Time frame: Day 17 (17 days after arrival in destination country)
Total unformed stool frequency from diarrheal episodes
Time frame: Day 17 (17 days after arrival in destination country)
Total duration of diarrheal episodes
Time frame: Day 17 (17 days after arrival in destination country)
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 24291168Behrens RH, Cramer JP, Jelinek T, Shaw H, von Sonnenburg F, Wilbraham D, Weinke T, Bell DJ, Asturias E, Pauwells HL, Maxwell R, Paredes-Paredes M, Glenn GM, Dewasthaly S, Stablein DM, Jiang ZD, DuPont HL. Efficacy and safety of a patch vaccine containing heat-labile toxin from Escherichia coli against travellers' diarrhoea: a phase 3, randomised, double-blind, placebo-controlled field trial in travellers from Europe to Mexico and Guatemala. Lancet Infect Dis. 2014 Mar;14(3):197-204. doi: 10.1016/S1473-3099(13)70297-4. Epub 2013 Nov 29.
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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 Sciences Center at Houston
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TD Vaccine System in people with Travelers' Diarrhea, run by Intercell USA, Inc. at 20 sites in 4 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 5 inclusion and 16 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 20 sites in United Kingdom, Mexico, Germany, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 cases with vaccine preventable outcome (time frame: Day 17 (17 days after arrival in destination country)). 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 NCT00993681, 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.