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
  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.


Condition Intervention Phase
Diarrhea
Biological: rFla-MBP
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Evaluation of an Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) in Volunteers

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:
  • Local and systemic reactions
  • Mucosal immunogenicity
  • Systemic immunogenicity

Estimated Enrollment: 32
Study Start Date: July 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124865

Locations
United States, Maryland
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
Investigators
Principal Investigator: David Tribble, MD, DrPH Naval Medical Research Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00124865     History of Changes
Other Study ID Numbers: NMRC 2002.0003, WRAIR 949, HSRRB A-11697, rFla-MBP
Study First Received: July 26, 2005
Last Updated: January 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
Campylobacter
Bacterial enteritis

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014