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

September 25, 2017 updated by: U.S. Army Medical Research and Development Command

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Walter Reed Army Institute of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Local and systemic reactions
Mucosal immunogenicity
Systemic immunogenicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

July 26, 2005

First Submitted That Met QC Criteria

July 26, 2005

First Posted (Estimate)

July 28, 2005

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRC 2002.0003
  • WRAIR 949 (Other Identifier: WRAIR)
  • HSRRB A-11697 (Other Identifier: USAMRMC)
  • rFla-MBP (Other Identifier: NMRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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