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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014