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

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