The main purpose of this study is to evaluate the body's immune response to the LT patch at different doses. The secondary purpose of this study is to evaluate the safety of the LT patches at different doses and the safety of the skin preparation system. Another secondary purpose is to compare the safety and the body's immune response to LT patches placed on the upper arm versus the lower back.
This is a randomized, double-blind, placebo-controlled, dose ranging, multicenter study. Subjects will be assigned to one of ten treatment groups and vaccinated according to the study group designation. Treatments will remain the same for first and second vaccinations (alternating left and right sides).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
406
LT patch applied on either the deltoid or the lower back.
Solano Clinical Research
Davis, California, United States
QUEST Research Institute
Bingham Farms, Michigan, United States
Asthma and Allergy Associates PC
Cortland, New York, United States
Radiant Research - Cincinnati
Cincinnati, Ohio, United States
To evaluate the immunogenicity of LT application at different doses
Time frame: 6 months
To evaluate the safety of LT application at different doses
Time frame: 6 months
To evaluate the safety of the skin preparation system
Time frame: 6 months
To compare patch performance (safety and immunogenicity) on different anatomical parts of the body
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Trials of Texas
San Antonio, Texas, United States