LT Vaccine Patch Self-Administration Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT00565461
First received: November 28, 2007
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Prevention of Travelers' Diarrhea
Biological: heat-labile enterotoxin of E. coli (LT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Intercell USA, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Safety of Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Evaluation of Immunogenicity for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety and Evaluation of Immunogenicity for Self-administration In-clinic Compared to Self-administration Away From the Clinic. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: November 2007
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
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)
37.5ug patch applied on either the deltoid or the thigh
Other Name: TD Vaccine System
Experimental: Group 2
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)
37.5ug patch applied on either the deltoid or the thigh
Other Name: TD Vaccine System
Experimental: Group 3
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)
37.5ug patch applied on either the deltoid or the thigh
Other Name: TD Vaccine System
Experimental: Group 4
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)
37.5ug patch applied on either the deltoid or the thigh
Other Name: TD Vaccine System

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565461

Locations
United States, Arkansas
Arkansas Medical Research Testing
Little Rock, Arkansas, United States, 72202
United States, Florida
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Intercell USA, Inc.
Investigators
Principal Investigator: Judith Forte, MD Arkansas Medical Research Testing
  More Information

No publications provided

Responsible Party: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT00565461     History of Changes
Other Study ID Numbers: ELT203
Study First Received: November 28, 2007
Results First Received: January 30, 2014
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 26, 2014