NCT00124865

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	rFla-MBP

Timeline

• Start date: 2005-07-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-07-28
• Last updated: 2017-09-26

Locations

1 site across 1 country: United States