LT Vaccine Patch Self-Administration Study

Prevention of Travelers' Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565461
• Other study ID #: ELT203
• Status: Completed
• Phase: Phase 2
• Start date: November 2007
• Est. completion date: August 2008

Study information

• Verified date: March 2020
• Source: Intercell USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Prevention of Travelers' Diarrhea

Intervention

Biological:
• heat-labile enterotoxin of E. coli (LT)
37.5ug patch applied on either the deltoid or the thigh

Locations

Country	Name	City	State
United States	Arkansas Medical Research Testing	Little Rock	Arkansas
United States	Jean Brown Research	Salt Lake City	Utah
United States	Miami Research Associates	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intercell USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Day 0, Day 14, Day 21, Day 28, Day 35, Day 194
Primary	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
Primary	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	Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch		6 months
Secondary	Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.		6 months
Secondary	Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.		6 months
Secondary	Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.		6 months
Secondary	Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine		6 months
Secondary	Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine		6 months
Secondary	Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic		6 months
Secondary	Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic		6 months