LT Vaccine Patch Self-Administration Study

NCT00565461 | Completed Phase 2 Results

• 1 other identifier: ELT203
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Prevention of Travelers' Diarrhea

Outcome Measures

Primary Outcomes (3)

• 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 (8)

• 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.

  6 months

• Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.

  6 months

• Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.

  6 months

• Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine

  6 months

Study Arms (4)

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)

Interventions

heat-labile enterotoxin of E. coli (LT) BIOLOGICAL

37.5ug patch applied on either the deltoid or the thigh

Also known as: TD Vaccine System

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Intercell USA, Inc.: lead

Study Sites (3)

Arkansas Medical Research Testing

Little Rock, Arkansas, 72202, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Results Point of Contact

• Title: Head Clinical Development
• Organization: Valneva Austria GmbH

info@valneva.com

0043120620

Study Officials

• Judith Forte, MD

  Arkansas Medical Research Testing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 30, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 30, 2020
• Results First Posted: April 21, 2014

Record last verified: 2020-03

Locations

US (3)