The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
600
Travelers' Diarrhea Vaccine System
Travelers' Diarrhea Vaccine System
Advanced Clinical Research Institute
Anaheim, California, United States
Miami Research Associates
South Miami, Florida, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
Radiant Research
Cincinnati, Ohio, United States
Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs
Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.
Time frame: Day 0 to Day 180
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Time frame: Day 0 to Day 180
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Time frame: Day 0 to Day 180
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Time frame: Day 0 to Day 180
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