Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) Dose-Ranging Study
NCT ID: NCT00124865
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2005-07-31
2006-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Interventions
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rFla-MBP
Eligibility Criteria
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Inclusion Criteria
* 70% accuracy on comprehension test
* Availability for required visits and telephone follow up
Exclusion Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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U.S. Army Medical Research and Development Command
FED
Responsible Party
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Principal Investigators
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David Tribble, MD, DrPH
Role: PRINCIPAL_INVESTIGATOR
Naval Medical Research Center
Locations
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Walter Reed Army Institute of Research
Silver Spring, Maryland, United States
Countries
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Other Identifiers
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WRAIR 949
Identifier Type: OTHER
Identifier Source: secondary_id
HSRRB A-11697
Identifier Type: OTHER
Identifier Source: secondary_id
rFla-MBP
Identifier Type: OTHER
Identifier Source: secondary_id
NMRC 2002.0003
Identifier Type: -
Identifier Source: org_study_id