Traveler's DiarrheaPhase 2NCT01040325
Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study
A Phase 2 study testing TD Vaccine System in people with Traveler's Diarrhea, run by Intercell USA, Inc. at 12 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Traveler's 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
- 723 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Dec 2009to Dec 2010
- 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
- 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 and second vaccination in the country of origin; females of child-bearing potential must agree not to become pregnant throughout the duration of study
- Subjects must have planned travel to DC, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 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 in a developing country within the last year;
- Women who are pregnant or breastfeeding;
- Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease;
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- History of Irritable Bowel Syndrome;
- Seizure disorder within the last year;
- Current use of immunosuppressive therapy (excluding inhaled steroids) or 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 from two weeks prior to randomization through the surveillance phase of the study;
- An employee of Intercell (global) or an immediate family member.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
India5 sites
Dr. Tito's Health Care and Diagnostic Centre
Goa, 403516
Prabhugaunker's Clinic
Goa, 403721
Wellesley Medicentre
Kolkata
Pushpawati Singhania Research Institute
New Delhi, 110017
Samvedna Hospital
Varanasi
United Kingdom5 sites
Bio-Kinetic Europe Ltd
Belfast, Northern Ireland, BT2 7 BA
Synexus Ltd
Chorley
Guy's Drug Research Unit
London
Hospital for Tropical Diseases
London
Synexus
Reading, Berkshire
Germany2 sites
Belinger Centrum Reise & Tropenmedizin
Berlin
Tropical Medicine and Bernhard-Nocht Ints
Hamburg
About this study
Official title: A Phase Two, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System in Travelers to Asia
The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.
- Conditions
- Traveler's Diarrhea
- Being tested
- TD Vaccine System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD Vaccine SystemBiological
TD Vaccine System containing heat labile enterotoxin of E. coli (LT)
TD Vaccine SystemBiological
TD Vaccine System Containing Placebo Product
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 358 subjects receive a two vaccination regimen with an LT patch Receives: Biological: TD Vaccine System |
| Placebo | Placebo comparator | 358 subjects receive a two vaccination regimen with 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: within 17 days after arrival in destination country
Secondary outcomes (1)
Incidence of moderate/severe diarrhea
Measured: within 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 posted29 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traveler's 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 723 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intercell USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Steffen, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040325
- Sponsor's protocol ID
- ELT209
- Other IDs
- EudraCT Number: 2009-015603-10
- Status last verified
- Jan 2012
- First submitted
- 25 Dec 2009
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 Two, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System in Travelers to Asia
- ClinicalTrials.gov ID
- NCT01040325
- Acronym / sponsor ID
- ELT209
- Conditions
- Traveler's Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 723 participants (actual)
- Lead sponsor
- Intercell USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Dec 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 TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.
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 |
|---|---|---|
| Active | Experimental | Biological: TD Vaccine System358 subjects receive a two vaccination regimen with an LT patch |
| Placebo | Placebo comparator | Biological: TD Vaccine System358 subjects receive a two vaccination regimen with 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 and second vaccination in the country of origin; females of child-bearing potential must agree not to become pregnant throughout the duration of study
- Subjects must have planned travel to DC, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 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 in 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 SystemTD Vaccine System containing heat labile enterotoxin of E. coli (LT) | Biological | Active |
| TD Vaccine SystemTD Vaccine System Containing Placebo Product | Biological | Placebo |
Primary outcome
Incidence of cases with vaccine preventable outcome
Time frame: within 17 days after arrival in destination country
1 secondary outcome
Incidence of moderate/severe diarrhea
Time frame: within 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.
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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.
Robert Steffen, MD principal investigator
University of Zurich
12 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 TD Vaccine System in people with Traveler's Diarrhea, run by Intercell USA, Inc. at 12 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 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 12 sites in India, United Kingdom, Germany. 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 cases with vaccine preventable outcome (time frame: within 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?
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.