Prevention of Travelers' DiarrheaPhase 2NCT00565461

LT Vaccine Patch Self-Administration Study

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 the immune responses achieved following self-administered heat-labile enterotoxin of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered vaccination. 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?: No, everyone receives an active treatment
How many people: 160 participants
Where: 3 sitesUnited States
Study dates: Nov 2007to Aug 2008
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

Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
Healthy adult males or females 18-64 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 of 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 or diaphragm, with spermicide), and IUD.

Who cannot join

Subjects meeting any of the following criteria are not eligible for participation in the study:
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

Show all 21Show fewer

Donated blood or blood products such as plasma within the past 30 days
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 traveler's diarrhea in the previous two years
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 (GI) 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 at the vaccination area(s) that would interfere with patch adhesion in the opinion of the Investigator
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 or at baseline; or
Employee of the investigational site.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Arkansas Medical Research Testing
Little Rock, Arkansas, 72202
Jean Brown Research
Salt Lake City, Utah, 84124
Miami Research Associates
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Open-Label Study to Compare the Immunogenicity and Safety of a Self-Administered LT Vaccine Patch With an LT Vaccine Patch Administered by a Clinician

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

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
37.5ug patch applied on either the deltoid or the thigh

Study groups in NCT00565461
Study group	Role	What they receive
Group 1	Experimental	40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician Receives: Biological: heat-labile enterotoxin of E. coli (LT)
Group 2	Experimental	40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician. Receives: Biological: heat-labile enterotoxin of E. coli (LT)
Group 3	Experimental	40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh. Receives: Biological: heat-labile enterotoxin of E. coli (LT)
Group 4	Experimental	40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh. Receives: 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.

GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.
GMT: geometric mean titer
Measured: Day 0, Day 14, Day 21, Day 28, Day 35, Day 194
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.
GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data.
Measured: Day 14, Day 21, Day 28, Day 35, Day 194
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.
seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA
Measured: Day 14, Day 21, Day 28, Day 35, Day 194

Secondary outcomes (8)

Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
Measured: 6 months
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
Measured: 6 months
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Measured: 6 months
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Measured: 6 months
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
Measured: 6 months
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
Measured: 6 months
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
Measured: 6 months
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
Measured: 6 months

Timeline

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

Nov 2007Aug 2008

First posted30 Nov 2007 (estimated)
Study startNov 2007
Primary completionJul 2008
Study completionAug 2008

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: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00565461
Sponsor's protocol ID: ELT203
Status last verified: Mar 2020
First submitted: 28 Nov 2007
Last updated: 30 Mar 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 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Open-Label Study to Compare the Immunogenicity and Safety of a Self-Administered LT Vaccine Patch With an LT Vaccine Patch Administered by a Clinician
ClinicalTrials.gov ID: NCT00565461
Acronym / sponsor ID: ELT203
Conditions: Prevention of Travelers' Diarrhea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Intercell USA, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Jul 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 30 Nov 2007 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Biological: heat-labile enterotoxin of E. coli (LT)40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician
Group 2	Experimental	Biological: heat-labile enterotoxin of E. coli (LT)40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.
Group 3	Experimental	Biological: heat-labile enterotoxin of E. coli (LT)40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
Group 4	Experimental	Biological: heat-labile enterotoxin of E. coli (LT)40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.

Who may qualify

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

Key inclusion criteria (3 listed)

Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
Healthy adult males or females 18-64 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 of 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 or diaphragm, with spermicide), and IUD.

Key exclusion criteria (21 listed)

Subjects meeting any of the following criteria are not eligible for participation in the study:
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

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 System37.5ug patch applied on either the deltoid or the thigh	Biological	Group 1, Group 2, Group 3, Group 4

Primary outcome

GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
Time frame: Day 0, Day 14, Day 21, Day 28, Day 35, Day 194
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMT: geometric mean titer
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
Time frame: Day 14, Day 21, Day 28, Day 35, Day 194
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data.
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
Time frame: Day 14, Day 21, Day 28, Day 35, Day 194
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA

8 secondary outcomes

Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
Time frame: 6 months
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
Time frame: 6 months
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Time frame: 6 months
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Time frame: 6 months
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
Time frame: 6 months
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
Time frame: 6 months
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
Time frame: 6 months
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
Time frame: 6 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
Clinician Administered (Deltoid)	40	40
Clinician Administered (Thigh)	40	39
Self Administered (In-clinic)	40	39
Self Administered (Non-clinic)	40	37

Primary outcome: GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.

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

Measure	Clinician Administered (Deltoid/ Thigh) n = 41	Self Administered (In-clinic & Non-clinic) n = 80
LT IgG GMTs - Day 0	362 (264 to 496)	442 (354 to 552)
LT IgG GMTs - Day 14	1974 (1196 to 3258)	2896 (2032 to 4127)
LT IgG GMTs - Day 21	4747 (3232 to 6973)	7545 (5759 to 9886)
LT IgG GMTs - Day 28	11153 (8255 to 15068)	12180 (9832 to 15089)
LT IgG GMTs - Day 35	12165 (9320 to 15877)	12745 (10519 to 15442)
LT IgG GMTs - Day 194	4997 (3753 to 6654)	6035 (4917 to 7409)
LT IgA GMTs - Day 0	54 (41 to 69)	53 (44 to 64)
LT IgA GMTs - Day 14	218 (142 to 335)	365 (270 to 494)

Population analysed: intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology

Primary outcome: GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.

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

Measure	Clinician Administered (Deltoid/ Thigh) n = 41	Self Administered (In-clinic & Non-clinic) n = 80
LT IgG GMFR - Day 14	6 (4 to 8)	7 (5 to 9)
LT IgG GMFR - Day 21	14 (9 to 20)	17 (13 to 23)
LT IgG GMFR - Day 28	31 (22 to 44)	28 (21 to 36)
LT IgG GMFR - Day 35	34 (23 to 49)	29 (22 to 38)
LT IgG GMFR - Day 194	14 (10 to 20)	14 (11 to 18)
LT IgA GMFR - Day 14	4 (3 to 6)	7 (5 to 9)
LT IgA GMFR - Day 21	8 (5 to 11)	12 (10 to 15)
LT IgA GMFR - Day 28	12 (9 to 16)	15 (12 to 18)

Population analysed: intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology

Primary outcome: Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.

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

Measure	Clinician Administered (Deltoid/ Thigh) n = 41	Self Administered (In-clinic & Non-clinic) n = 80
LT IgG SCR - Day 14	65 (48 to 79)	73 (61 to 82)
LT IgG SCR - Day 21	92 (79 to 98)	98 (91 to 100)
LT IgG SCR - Day 28	98 (87 to 100)	99 (93 to 100)
LT IgG SCR - Day 35	100 (91 to 100)	99 (93 to 100)
LT IgG SCR - Day 194	97 (87 to 100)	100 (95 to 100)
LT IgA SCR - Day 14	48 (32 to 64)	59 (47 to 70)
LT IgA SCR - Day 21	69 (52 to 83)	85 (75 to 92)
LT IgA SCR - Day 28	83 (67 to 93)	90 (81 to 96)

Population analysed: intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clinician Administered (Deltoid)	1 of 40 (2.5%)	40 of 40 (100%)	Not reported
Clinician Administered (Thigh)	3 of 40 (7.5%)	40 of 40 (100%)	Not reported
Self Administered (In-clinic)	0 of 40 (0%)	40 of 40 (100%)	Not reported
Self Administered (Non-clinic)	0 of 40 (0%)	40 of 40 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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.

Judith Forte, MD principal investigator

Arkansas Medical Research Testing

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 21 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 30 Mar 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. 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?

GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. (time frame: Day 0, Day 14, Day 21, Day 28, Day 35, 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 NCT00565461.

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 30 Mar 2020.