DiarrheaPhase 2NCT01067781

Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

A Phase 2 study testing Heat-Labile Enterotoxin of E. coli (LT) in people with Diarrhea, run by Intercell USA, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing 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 E. coli (LT)
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 600 participants
Where: 5 sitesUnited States
Study dates: Feb 2010to Mar 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

A female or male 18-64 (inclusive) years of age;
In good health as determined by medical history and screening exam;
Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the duration of study.

Who cannot join

Abnormalities at physical exam [as determined by the Toxicity Grading Scale (Grade 1-4)];
Laboratory abnormalities [as determined by the Toxicity Grading Scale (Grade 1 4)] at screening;
Participated in research involving investigational product within 30 days before planned date of first vaccination;
Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd;
Women who are pregnant or breastfeeding;
Clinically significant underlying enteric, pulmonary, cardiac or renal disease;

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Current seizure disorder;
Current use of immunosuppressive therapy (inhaled steroids are allowed);
Known or suspected alcohol abuse or illicit drug use within the last year;
Positive Serology for HIV-1, HIV-2, HbsAg, or HCV;
Known allergies to any component of the vaccine including adhesives;
An employee of the study site;
An employee of Intercell (global) or an immediate family member;
Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites;
Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Advanced Clinical Research Institute
Anaheim, California, 92801
Radiant Research
Cincinnati, Ohio, 45249
Johnson County Clinical Trials
Lenexa, Kansas, 66219
Clinical Trials of Texas
San Antonio, Texas, 78229
Miami Research Associates
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 2, Gender-Stratified, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Two Vaccination Regimen With the Travelers' Diarrhea Vaccine System in Healthy Adults

Conditions: Diarrhea
Being tested: Heat-Labile Enterotoxin of E. coli (LT), Placebo
Keywords: Prevention of Travelers' Diarrhea
Medical subject headings: Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Heat-Labile Enterotoxin of E. coli (LT)Biological
Travelers' Diarrhea Vaccine System
PlaceboBiological
Travelers' Diarrhea Vaccine System

Study groups in NCT01067781
Study group	Role	What they receive
1	Experimental	Two vaccination regimen with an LT patch (no swabbing) Receives: Biological: Heat-Labile Enterotoxin of E. coli (LT)
2	Experimental	Two vaccination regimen with an LT patch (with swabbing) Receives: Biological: Heat-Labile Enterotoxin of E. coli (LT)
3	Placebo comparator	Two vaccination regimen with a placebo patch (no swabbing) Receives: Biological: Placebo
4	Placebo comparator	Two vaccination regimen with a placebo patch (with swabbing) Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs
Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.
Measured: Day 0 to Day 180

Secondary outcomes (3)

Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Measured: Day 0 to Day 180
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Measured: Day 0 to Day 180
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Measured: Day 0 to Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Mar 2012

First posted12 Feb 2010 (estimated)
Study startFeb 2010
Primary completionSep 2010
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01067781
Sponsor's protocol ID: ELT208
Status last verified: Feb 2020
First submitted: 9 Feb 2010
Last updated: 10 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diarrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Gender-Stratified, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Two Vaccination Regimen With the Travelers' Diarrhea Vaccine System in Healthy Adults
ClinicalTrials.gov ID: NCT01067781
Acronym / sponsor ID: ELT208
Conditions: Diarrhea
Keywords: Prevention of Travelers' Diarrhea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: Intercell USA, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Sep 2010 (actual)
Study completion: Mar 2012 (actual)
First posted: 12 Feb 2010 (estimated)
Results: Posted 13 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Biological: Heat-Labile Enterotoxin of E. coli (LT)Two vaccination regimen with an LT patch (no swabbing)
2	Experimental	Biological: Heat-Labile Enterotoxin of E. coli (LT)Two vaccination regimen with an LT patch (with swabbing)
3	Placebo comparator	Biological: PlaceboTwo vaccination regimen with a placebo patch (no swabbing)
4	Placebo comparator	Biological: PlaceboTwo vaccination regimen with a placebo patch (with swabbing)

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

A female or male 18-64 (inclusive) years of age;
In good health as determined by medical history and screening exam;
Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the duration of study.

Key exclusion criteria (15 listed)

Abnormalities at physical exam [as determined by the Toxicity Grading Scale (Grade 1-4)];
Laboratory abnormalities [as determined by the Toxicity Grading Scale (Grade 1 4)] at screening;
Participated in research involving investigational product within 30 days before planned date of first vaccination;
Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd;
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
Heat-Labile Enterotoxin of E. coli (LT)Travelers' Diarrhea Vaccine System	Biological	1, 2
PlaceboTravelers' Diarrhea Vaccine System	Biological	3, 4

Primary outcome

Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs
Time frame: Day 0 to Day 180
Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.

3 secondary outcomes

Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
Time frame: Day 0 to Day 180
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
Time frame: Day 0 to Day 180
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
Time frame: Day 0 to Day 180

Results and safety

Results posted to the registry on 13 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: 37.5μg LT, No Swab	203	173
Group 2: 37.5μg LT, Swab	199	168
Group 3: 0μg LT, No Swab	97	89
Group 4: 0μg LT, Swab	101	89

Primary outcome: Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs

Time frame: Day 0 to Day 180. Number. Unit: participants

Measure	Group 1 & 2 Combined: 37.5µg LT Patch n = 402	Group 3 & 4 Combined: Placebo Patch (0µg LT) n = 198
Solicited Local Adverse Events (1st vaccination)	318	93
Solicited Local AEs (2nd vaccination)	327	62
Non-solicited Local AEs (1st vaccination)	20	3
Non-solicited Local AEs (2nd vaccination)	11	3
Solicited Systemic AEs (overall)	134	59
Non-solicited Systemic AEs (overall)	296	148
Serious AEs	4	0

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: 37.5μg LT, No Swab	1 of 203 (0.5%)	197 of 203 (97%)	Not reported
Group 2: 37.5μg LT, Swab	3 of 199 (1.5%)	192 of 199 (96.5%)	Not reported
Group 3: 0μg LT, No Swab	0 of 97 (0%)	90 of 97 (92.8%)	Not reported
Group 4: 0μg LT, Swab	0 of 101 (0%)	92 of 101 (91.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Intercell Home PageLink 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.

Eric Sheldon, MD principal investigator

Miami Research Associates

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 Heat-Labile Enterotoxin of E. coli (LT) in people with 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 3 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 10 Feb 2020. 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?

Yes. Results are posted in the registry (first posted 13 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs (time frame: Day 0 to Day 180). 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 NCT01067781.

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 10 Feb 2020.