LT Vaccine Patch Self-Administration Study

Intercell

Status and phase: Completed; Phase 2

Conditions: Prevention of Travelers' Diarrhea

Treatments: Biological: heat-labile enterotoxin of E. coli (LT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00565461

ELT203

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Biological: heat-labile enterotoxin of E. coli (LT)

Group 2

Experimental group

Description:

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.

Treatment:

Biological: heat-labile enterotoxin of E. coli (LT)

Group 3

Experimental group

Description:

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.

Treatment:

Biological: heat-labile enterotoxin of E. coli (LT)

Group 4

Experimental group

Description:

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.

Treatment:

Biological: heat-labile enterotoxin of E. coli (LT)