Traveler's DiarrheaPhase 2NCT00672035
Prevention, Randomized, Double-Blinded, Placebo-Controlled, Parallel Assignment, Safety/Efficacy Study
A Phase 2 study testing Biological: heat-labile enterotoxin of E. coli (LT) in people with Traveler's Diarrhea, run by Intercell USA, Inc. at 5 sites in United States.
Trial summary
The main purpose of this study is to evaluate the body's immune response to the LT patch at different doses. The secondary purpose of this study is to evaluate the safety of the LT patches at different doses and the safety of the skin preparation system. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Traveler's Diarrhea
- What is being tested?
- Biological: heat-labile enterotoxin of E. coli (LT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2006to Jul 2008
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males or females 18 to 40 years of age with signed informed consent.
- Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours prior to each vaccination with understanding (through informed consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study.
- Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom, diaphragm with spermicide), and IUD.
- Subjects meeting any of the following criteria are not eligible for participation in the study:
Who cannot join
- Laboratory abnormalities.
- Abnormalities at physical examination
- Known allergies to any component of the vaccine.
- Known disturbance of coagulation.
- Known allergies to adhesives.
- Participated in unrelated research involving investigational product within 30 days before planned date of first vaccination.
Show all 25Show fewer
- Ever received investigational enterotoxigenic E. coli, LT, or LT(R192G) or NasalFlu, Berna Biotech, Ltd.
- Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™).
- Medical history of acute or chronic skin disease at vaccination site(s).
- Active skin allergy.
- Recent or regular use of oral or injected steroid medications.
- Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to first vaccination.
- Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, end-stage renal disease, as determined by the Investigator.
- Positive serology for HIV-1, HIV-2, HBsAg, or HCV.
- History of severe atopy. Signs or history of acute skin infection, sunburn or skin abnormalities on the vaccination area(s) including fungal infections, severe acne, history of keloid formation, or active contact dermatitis.
- Artificial tanning (UV radiation) over the duration of the study including the screening period.
- Hirsute (significant amount of hair) at vaccination area(s).
- Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatological monitoring of the vaccination site(s).
- Fever equal to or greater than 38.0°C (≥100.4°F) at the time of planned vaccination.
- Suspicion of or recent history of alcohol or substance abuse.
- Donated blood or blood products such as plasma within the past 30 days.
- Women who are pregnant or breastfeeding.
- Employee of the investigational site.
- Medical history of achlorhydria.
- History of abdominal surgery (excluding C-section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal illness.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
QUEST Research Institute
Bingham Farms, Michigan, 48025
Radiant Research - Cincinnati
Cincinnati, Ohio, 45249
Asthma and Allergy Associates PC
Cortland, New York, 13045
Solano Clinical Research
Davis, California, 95616
Clinical Trials of Texas
San Antonio, Texas, 78229
About this study
Official title: Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging Study to Assess the Immunogenicity and Safety of LT Application in Healthy Adults
The main purpose of this study is to evaluate the body's immune response to the LT patch at different doses.
The secondary purpose of this study is to evaluate the safety of the LT patches at different doses and the safety of the skin preparation system. Another secondary purpose is to compare the safety and the body's immune response to LT patches placed on the upper arm versus the lower back.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, dose ranging, multicenter study. Subjects will be assigned to one of ten treatment groups and vaccinated according to the study group designation. Treatments will remain the same for first and second vaccinations (alternating left and right sides).
- Conditions
- Traveler's Diarrhea
- Being tested
- Biological: heat-labile enterotoxin of E. coli (LT)
- Keywords
- LT, Healthy Adults, Dose Ranging, Patch, Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: heat-labile enterotoxin of E. coli (LT)Biological
LT patch applied on either the deltoid or the lower back.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 7.5µg LT Dose placed at the Deltoid on Day 0 and Day 21 Receives: Biological: Biological: heat-labile enterotoxin of E. coli (LT) |
| 2 | Experimental | 7.5µg LT Dose placed at the Lower Back on Day 0 and Day 21 Receives: Biological: Biological: heat-labile enterotoxin of E. coli (LT) |
| 3 | Experimental | 22.5µg LT Dose placed at the Deltoid on Day 0 and Day 21 Receives: Biological: Biological: heat-labile enterotoxin of E. coli (LT) |
| 4 | Experimental | 22.5µg LT Dose placed at the Lower Back on Day 0 and Day 21 Receives: Biological: Biological: heat-labile enterotoxin of E. coli (LT) |
| 5 | Experimental | 37.5µg LT Dose placed at the Deltoid on Day 0 and Day 21 Receives: Biological: Biological: heat-labile enterotoxin of E. coli (LT) |
| 6 | Experimental | 37.5µg LT Dose placed at the Lower Back on Day 0 and Day 21 Receives: Biological: Biological: heat-labile enterotoxin of E. coli (LT) |
| 7 | Experimental | 50µg LT Dose placed at the Deltoid on Day 0 and Day 21 Receives: Biological: Biological: heat-labile enterotoxin of E. coli (LT) |
| 8 | Experimental | 50µg LT Dose placed at the Lower Back on Day 0 and Day 21 Receives: Biological: Biological: heat-labile enterotoxin of E. coli (LT) |
| 9 | Placebo comparator | Placebo (0µg LT) placed at the Deltoid on Day 0 and Day 21 Receives: Biological: Biological: heat-labile enterotoxin of E. coli (LT) |
| 10 | Placebo comparator | Placebo (0µg LT) placed at the Lower Back on Day 0 and Day 21 Receives: Biological: Biological: heat-labile enterotoxin of E. coli (LT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the immunogenicity of LT application at different doses
Measured: 6 months
Secondary outcomes (3)
To evaluate the safety of LT application at different doses
Measured: 6 months
To evaluate the safety of the skin preparation system
Measured: 6 months
To compare patch performance (safety and immunogenicity) on different anatomical parts of the body
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2006
- Study completionJul 2008
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
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intercell USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Noss, MD, Principal investigator, Radiant Research, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672035
- Sponsor's protocol ID
- ELT202
- Status last verified
- Mar 2012
- First submitted
- 2 May 2008
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
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
- Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging Study to Assess the Immunogenicity and Safety of LT Application in Healthy Adults
- ClinicalTrials.gov ID
- NCT00672035
- Acronym / sponsor ID
- ELT202
- Conditions
- Traveler's Diarrhea
- Keywords
- LT, Healthy Adults, Dose Ranging, Patch, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Intercell USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 May 2008 (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 main purpose of this study is to evaluate the body's immune response to the LT patch at different doses.
The secondary purpose of this study is to evaluate the safety of the LT patches at different doses and the safety of the skin preparation system. Another secondary purpose is to compare the safety and the body's immune response to LT patches placed on the upper arm versus the lower back.
Detailed description
This is a randomized, double-blind, placebo-controlled, dose ranging, multicenter study. Subjects will be assigned to one of ten treatment groups and vaccinated according to the study group designation. Treatments will remain the same for first and second vaccinations (alternating left and right sides).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Biological: heat-labile enterotoxin of E. coli (LT)7.5µg LT Dose placed at the Deltoid on Day 0 and Day 21 |
| 2 | Experimental | Biological: Biological: heat-labile enterotoxin of E. coli (LT)7.5µg LT Dose placed at the Lower Back on Day 0 and Day 21 |
| 3 | Experimental | Biological: Biological: heat-labile enterotoxin of E. coli (LT)22.5µg LT Dose placed at the Deltoid on Day 0 and Day 21 |
| 4 | Experimental | Biological: Biological: heat-labile enterotoxin of E. coli (LT)22.5µg LT Dose placed at the Lower Back on Day 0 and Day 21 |
| 5 | Experimental | Biological: Biological: heat-labile enterotoxin of E. coli (LT)37.5µg LT Dose placed at the Deltoid on Day 0 and Day 21 |
| 6 | Experimental | Biological: Biological: heat-labile enterotoxin of E. coli (LT)37.5µg LT Dose placed at the Lower Back on Day 0 and Day 21 |
| 7 | Experimental | Biological: Biological: heat-labile enterotoxin of E. coli (LT)50µg LT Dose placed at the Deltoid on Day 0 and Day 21 |
| 8 | Experimental | Biological: Biological: heat-labile enterotoxin of E. coli (LT)50µg LT Dose placed at the Lower Back on Day 0 and Day 21 |
| 9 | Placebo comparator | Biological: Biological: heat-labile enterotoxin of E. coli (LT)Placebo (0µg LT) placed at the Deltoid on Day 0 and Day 21 |
| 10 | Placebo comparator | Biological: Biological: heat-labile enterotoxin of E. coli (LT)Placebo (0µg LT) placed at the Lower Back on Day 0 and Day 21 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult males or females 18 to 40 years of age with signed informed consent.
- Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours prior to each vaccination with understanding (through informed consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study.
- Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom, diaphragm with spermicide), and IUD.
- Subjects meeting any of the following criteria are not eligible for participation in the study:
Key exclusion criteria (25 listed)
- Laboratory abnormalities.
- Abnormalities at physical examination
- Known allergies to any component of the vaccine.
- Known disturbance of coagulation.
- Known allergies to adhesives.
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 |
|---|---|---|
| Biological: heat-labile enterotoxin of E. coli (LT)LT patch applied on either the deltoid or the lower back. | Biological | 1, 10, 2, 3, 4, 5, 6, 7, 8, 9 |
Primary outcome
To evaluate the immunogenicity of LT application at different doses
Time frame: 6 months
3 secondary outcomes
To evaluate the safety of LT application at different doses
Time frame: 6 months
To evaluate the safety of the skin preparation system
Time frame: 6 months
To compare patch performance (safety and immunogenicity) on different anatomical parts of the body
Time frame: 6 months
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.
Related trials for Traveler's Diarrhea
RecruitingPhase 4
Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct
Diarrhoea;Acute, Diarrhea Travelers
RecruitingEarly Phase 1
G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Travelers Diarrhea
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.
Michael J Noss, MD principal investigator
Radiant Research, Cincinnati
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biological: heat-labile enterotoxin of E. coli (LT) in people with Traveler's Diarrhea, run by Intercell USA, Inc. at 5 sites in United States.
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 25 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 5 sites in United States. 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?
To evaluate the immunogenicity of LT application at different doses (time frame: 6 months). 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.