This study is an open-labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses.
This is an open labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses according to the following chart: Group / N\* / rFla-MBP A / 8/ 25 micrograms B / 8/ 125 micrograms C / 8/ 625 micrograms D / 8/ 1000 micrograms \* minimum of 6 volunteers per group An interval no less than 60 days following the first dose will separate the first dose of each volunteer group receiving different rFla-MBP doses. All volunteers will receive three immunizations. The first dosing time point is Day 0, the second is Day 14 (+/- 1 day), the third is day 28 (+/- 2 days). Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States
Local and systemic reactions
Mucosal immunogenicity
Systemic immunogenicity
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