Expired Study
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Silver Spring, Maryland 20910


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00124865


Primary Contact:

Principal Investigator
David Tribble, MD, DrPH
Naval Medical Research Center


Backup Contact:

N/A


Location Contact:

Silver Spring, Maryland 20910
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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