LT Vaccine Patch Self-Administration Study | NCT00565461

NCT00565461

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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.	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.	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.	Biological: heat-labile enterotoxin of E. coli (LT)

Name	Type	Description	Arm Group Labels	Other Names
heat-labile enterotoxin of E. coli (LT)	Biological	37.5ug patch applied on either the deltoid or the thigh	Group 1 Group 2 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	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	Day 14, Day 21, Day 28, Day 35, Day 194

Secondary Outcomes

Measure	Description	Time Frame
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch		6 months
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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.

Name	Affiliation	Role
Judith Forte, MD	Arkansas Medical Research Testing	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Medical Research Testing		Little Rock	Arkansas	72202	United States
Miami Research Associates

Arm/Group Information

ID	Title	Description
FG000	Clinician Administered (Deltoid)	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 heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
FG001	Clinician Administered (Thigh)	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. heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
FG002	Self Administered (In-clinic)	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. heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
FG003	Self Administered (Non-clinic)	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. heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Clinician Administered (Deltoid)	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 heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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

Posted

Geometric Mean

95% Confidence Interval

geometric mean titers

Day 0, Day 14, Day 21, Day 28, Day 35, Day 194

ID	Title	Description
OG000	Clinician Administered (Deltoid/ Thigh)	st vaccination: administered by clinician; location: deltoid nd vaccination: administered by clinician; location: thigh

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Clinician Administered (Deltoid)	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 heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh