Diarrhea Clinical Trial
Official title:
Safety and Immunogenicity Evaluation of an Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) in Volunteers
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.
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