Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) Dose-Ranging Study

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.

Inclusion Criteria: Healthy adult 70% accuracy on comprehension test Availability for required visits and telephone follow up Exclusion Criteria: Pregnancy or breastfeeding Chronic health problems Abnormalities found on physical examination Use of immunosuppressive drugs, such as corticosteroids or chemotherapy Positive blood test for HIV-1, hepatits B surface antigen (HBsAG) or hepatitis C virus (HCV) Abnormalities found on basic laboratory screening Prior exposure to Campylobacter Current smoker Chronic sinusitis or seasonal rhinitis