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

United States Army Medical Research and Development Command (USAMRDC)

Status and phase: Withdrawn; Phase 1

Conditions: Diarrhea

Treatments: Biological: rFla-MBP

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00124865

WRAIR 949 (Other Identifier)

rFla-MBP (Other Identifier)

HSRRB A-11697 (Other Identifier)

NMRC 2002.0003

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)