LT Vaccine Patch Self-Administration Study
This study has been completed.
Sponsor:
Intercell USA, Inc.
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT00565461
First received: November 28, 2007
Last updated: March 13, 2012
Last verified: March 2012
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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:
- Evaluation of immunogenicity of a self-administered LT vaccine patch (in-clinic or away from clinic) compared to a clinician-administered LT vaccine patch. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
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 |
| Last Updated: | March 13, 2012 |
| 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 May 19, 2013