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

Phase 1

Withdrawn

• Conditions: Diarrhea

• Registration Number: NCT00124865
• Lead Sponsor: U.S. Army Medical Research and Development Command

Brief Summary

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.

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 Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-26
• Study First Submitted QC: 2005-07-26
• Study First Posted: 2005-07-28
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Systemic immunogenicity
Local and systemic reactions
Mucosal immunogenicity

Trial Locations

Locations (1)

Walter Reed Army Institute of Research; 🇺🇸 Silver Spring, Maryland, United States