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

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00124865
First received: July 26, 2005
Last updated: January 7, 2010
Last verified: January 2010
History of Changes

July 26, 2005
January 7, 2010
July 2005
November 2006   (final data collection date for primary outcome measure)
  • Local and systemic reactions
  • Mucosal immunogenicity
  • Systemic immunogenicity
Same as current
Complete list of historical versions of study NCT00124865 on ClinicalTrials.gov Archive Site
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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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Diarrhea
Biological: rFla-MBP
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00124865
NMRC 2002.0003, WRAIR 949, HSRRB A-11697, rFla-MBP
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U.S. Army Office of the Surgeon General
Not Provided
Principal Investigator: David Tribble, MD, DrPH Naval Medical Research Center
Walter Reed Army Institute of Research (WRAIR)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP