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

Diarrhea Clinical Trial

Official title:

Safety and Immunogenicity Evaluation of an Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) in Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00124865
• Other study ID #: NMRC 2002.0003
• Secondary ID: WRAIR 949HSRRB A
• Status: Withdrawn
• Phase: Phase 1
• First received: July 26, 2005
• Last updated: September 25, 2017
• Start date: July 2005
• Est. completion date: November 2006

Study information

• Verified date: September 2017
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea

Intervention

Biological:
• rFla-MBP

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local and systemic reactions
Primary	Mucosal immunogenicity
Primary	Systemic immunogenicity