Prevention of Travelers' DiarrheaPhase 2NCT00751777

Traveler's Diarrhea (TD) Automated Process

A Phase 2 study testing heat-labile enterotoxin of E. coli (LT) in people with Prevention of Travelers' Diarrhea, run by Intercell USA, Inc. at 3 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

To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Prevention of Travelers' 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: 120 participants
Where: 3 sitesUnited States
Study dates: Sep 2008to Nov 2009
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

Healthy adult males or females, 18-64 years of age (inclusive) at the planned start of the study (first vaccination on Day 0)
Signed Informed Consent
Women who are not post-menopausal or surgically sterile must have a negative serum/urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant and 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 or diaphragm, with spermicide), and IUD.

Who cannot join

Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1 4)] at laboratory screening
Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)]
Known allergies to any component of the vaccine
Known allergies to adhesives
Participated in research involving investigational product within 30 days before planned date of first vaccination or within 90 days after first vaccination
Donated blood or blood products such as plasma within 30 days prior to planned date of first vaccination or within 90 days after first vaccination

Show all 20Show 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™)
History of diarrhea while traveling in a developing country within the last year
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
Positive serology for HIV-1, HIV-2, HBsAg, or HCV
Medical history of acute or chronic skin disease at vaccination area(s)
Active skin allergy
Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation
Excessively hirsute and unwilling to clip hair at the vaccination area(s)
Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s)
Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination
Women who are pregnant or breastfeeding
Acute illness at screening and unresolved at time of planned vaccination
Employee of the investigational site

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Clinical Trials of Texas
San Antonio, Texas, 78229
Miami Research Associates
South Miami, Florida, 33143
Solano Clinical Research
Vallejo, California, 94589

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Two Vaccination Regimen With an LT Vaccine Patch in Healthy Adults

To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.

Conditions: Prevention of Travelers' Diarrhea
Being tested: heat-labile enterotoxin of E. coli (LT), Placebo

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
Also called TD Vaccine System
Travelers' Diarrhea Vaccine System
PlaceboBiological
Also called TD Vaccine System
Travelers' Diarrhea Vaccine System

Study groups in NCT00751777
Study group	Role	What they receive
Group 1: 37.5 µg LT patch	Experimental	80 subjects will receive a two vaccination regimen with a LT patch. Receives: Biological: heat-labile enterotoxin of E. coli (LT)
Group 2: 0 µg LT patch (placebo)	Placebo comparator	40 subjects will receive a two vaccination regimen with a placebo patch. Receives: Biological: Placebo

What is being measured

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

Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
Measured: Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.
Measured: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
Definition of SCR:
- Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline
- Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline
Measured: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194

Secondary outcomes (5)

Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
LT subjects (Group 1) were followed for six months longer (until Day 380) than Placebo subjects (Group 2) (until Day 194)
Measured: 13 months
Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear
Measured: 1 month
Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group
GMT
Measured: 13 months
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
GMFR
Measured: 13 months
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
SCR
Measured: 13 months

Timeline

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

Sep 2008Nov 2009

First posted12 Sep 2008 (estimated)
Study startSep 2008
Primary completionNov 2009
Study completionNov 2009

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 Prevention of 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00751777
Sponsor's protocol ID: ELT207
Status last verified: Jan 2020
First submitted: 11 Sep 2008
Last updated: 29 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Two Vaccination Regimen With an LT Vaccine Patch in Healthy Adults
ClinicalTrials.gov ID: NCT00751777
Acronym / sponsor ID: ELT207
Conditions: Prevention of Travelers' Diarrhea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Intercell USA, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 12 Sep 2008 (estimated)
Results: Posted 21 Apr 2014

Clinical summary

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

To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.

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
Group 1: 37.5 µg LT patch	Experimental	Biological: heat-labile enterotoxin of E. coli (LT)80 subjects will receive a two vaccination regimen with a LT patch.
Group 2: 0 µg LT patch (placebo)	Placebo comparator	Biological: Placebo40 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 (3 listed)

Healthy adult males or females, 18-64 years of age (inclusive) at the planned start of the study (first vaccination on Day 0)
Signed Informed Consent
Women who are not post-menopausal or surgically sterile must have a negative serum/urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant and 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 or diaphragm, with spermicide), and IUD.

Key exclusion criteria (20 listed)

Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1 4)] at laboratory screening
Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)]
Known allergies to any component of the vaccine
Known allergies to adhesives
Participated in research involving investigational product within 30 days before planned date of first vaccination or within 90 days after first vaccination

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)Also: TD Vaccine SystemTravelers' Diarrhea Vaccine System	Biological	Group 1: 37.5 µg LT patch
PlaceboAlso: TD Vaccine SystemTravelers' Diarrhea Vaccine System	Biological	Group 2: 0 µg LT patch (placebo)

Primary outcome

Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
Time frame: Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
Time frame: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
Time frame: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Definition of SCR: * Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline * Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline

5 secondary outcomes

Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Time frame: 13 months
Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear
Time frame: 1 month
Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group
Time frame: 13 months
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
Time frame: 13 months
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
Time frame: 13 months

Results and safety

Results posted to the registry on 21 Apr 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: 37.5 µg LT Patch	81	70
Group 2: 0 µg LT Patch (Placebo)	39	36

Primary outcome: Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo

Time frame: Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194. Geometric mean (95% Confidence Interval). Unit: geometric mean titer

Measure	Group 1: 37.5 µg LT Patch n = 76	Group 2: 0 µg LT Patch (Placebo) n = 34
GMT LT IgG - Day 0	432.6 (349.0 to 536.2)	400.5 (290.5 to 552.2)
GMT LT IgG - Day 14	4477.5 (3249.6 to 6169.4)	490.6 (303.8 to 792.2)
GMT LT IgG - Day 21	9107.7 (6791.9 to 12213.0)	462.1 (298.0 to 716.6)
GMT LT IgG - Day 28	13411.9 (10420 to 17263.5)	372.6 (255.4 to 543.4)
GMT LT IgG - Day 35	15024.3 (11893 to 18979.4)	383.6 (270.5 to 544.0)
GMT LT IgG - Day 90	6823.7 (5553.1 to 8385.1)	156.2 (114.5 to 213.1)
GMT LT IgG - Day 194	2489.2 (1965.5 to 3152.4)	100.2 (70.7 to 142.0)
GMT LT IgA - Day 0	49.4 (37.4 to 65.1)	58.9 (38.9 to 89.1)

Population analysed: Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.

Primary outcome: Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo

Time frame: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194. Number (95% Confidence Interval). Unit: ratio

Measure	Group 1: 37.5 µg LT Patch n = 76	Group 2: 0 µg LT Patch (Placebo) n = 34
GMFR LT IgG - Day 14	10.4 (7.4 to 14.5)	1.2 (0.7 to 2.0)
GMFR LT IgG - Day 21	21.1 (15.2 to 29.2)	1.2 (0.7 to 1.9)
GMFR LT IgG - Day 28	31.0 (23.5 to 41.0)	0.9 (0.6 to 1.4)
GMFR LT IgG - Day 35	34.7 (26.6 to 45.4)	1.0 (0.6 to 1.4)
GMFR LT IgG - Day 90	16.0 (12.4 to 20.8)	0.4 (0.3 to 0.6)
GMFR LT IgG - Day 194	5.7 (4.3 to 7.5)	0.2 (0.2 to 0.4)
GMFR LT IgA - Day 14	8.0 (5.8 to 11.0)	1.0 (0.6 to 1.6)
GMFR LT IgA - Day 21	12.5 (9.3 to 16.8)	1.0 (0.7 to 1.6)

Primary outcome: Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo

Time frame: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1: 37.5 µg LT Patch n = 76	Group 2: 0 µg LT Patch (Placebo) n = 34
SCR LT IgG - Day 14	77.6 (66.6 to 86.4)	8.8 (1.9 to 23.7)
SCR LT IgG - Day 21	89.5 (80.3 to 95.3)	8.8 (1.9 to 23.7)
SCR LT IgG - Day 28	97.4 (90.8 to 99.7)	2.9 (0.1 to 15.3)
SCR LT IgG - Day 35	97.4 (90.8 to 99.7)	5.9 (0.7 to 19.7)
SCR LT IgG - Day 90	98.7 (92.8 to 100)	9.1 (1.9 to 24.3)
SCR LT IgG - Day 194	83.3 (72.7 to 91.1)	0 (0 to 10.6)
SCR LT IgA - Day 14	57.9 (46.0 to 69.1)	0.0 (0.0 to 10.3)
SCR LT IgA - Day 21	71.1 (59.5 to 80.9)	0.0 (0.0 to 10.3)

5 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: 37.5 µg LT Patch	1 of 81 (1.2%)	79 of 81 (97.5%)	Not reported
Group 2: 0 µg LT Patch (Placebo)	2 of 39 (5.1%)	32 of 39 (82.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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

3 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 Prevention of Travelers' Diarrhea, run by Intercell USA, Inc. at 3 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 20 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 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 21 Apr 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?

Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo (time frame: Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194). The study lists 3 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 NCT00751777.

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 29 Jan 2020.