This study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy adults 18-49 years of age.
The purpose of this trial is to evaluate the safety and tolerability of graded, ascending doses of JVRS-100 adjuvant when administered in combination with a vaccine antigen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
128
One vaccination on Day 0 with Fluzone vaccine at 22.5µg mixed with JVRS-100 adjuvant at one of four dose levels (7.5µg, 25µg, 75µg, 225µg) given by IM injection in the upper deltoid.
One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.
One vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid.
Miami Research Associates
Miami, Florida, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Comparison of adverse events between treatment groups
Time frame: Active Study Duration
Dose-response analysis of HAI geometric mean titers (GMT)
Time frame: 5 time points
Safety endpoints include between treatment group analyses of all safety parameters as described for the primary endpoint for each ascending dose cohort.
Time frame: 2 periods
Seroprotection and seroconversion rates to various antigens, distribution of antibody titers, duration of HAI antibody titers, and assessment of cross-reactive HAI responses against "drifted" strains.
Time frame: 5 time points
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