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Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00124865

Enrollment

Registered

2005-07-28

Start date

2005-07-31

Completion date

2006-11-30

Last updated

2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea

Keywords

Campylobacter, Bacterial enteritis

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.

Interventions

BIOLOGICALrFla-MBP

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Local and systemic reactions	—
Mucosal immunogenicity	—
Systemic immunogenicity	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026