Diarrhea |
Dysentery |
Clinical Trial: Intranasal rFla-MBP Vaccine Dose-Ranging
This study is currently recruiting patients.
Verified by Walter Reed Army Institute of Research (WRAIR) June 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Diarrhea | Vaccine: rFla-MBP | Phase I |
MedlinePlus related topics: Diarrhea
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: Safety and Immunogenicity Evaluation of an Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) in Volunteers
Expected Total Enrollment: 32
Study start: July 2005
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.
Eligibility
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, HBsAG or HCV
- Abnormalities found on basic laboratory screening
- Prior exposure to Campylobacter
- Current smoker
- Chronic sinusitis or seasonal rhinitis
Location and Contact Information
Felicia Breedy 866-856-3259 clinical2@na.amedd.army.mil
Maryland
Walter Reed Army Institute of Research, Silver Spring, Maryland, 20910, United States; Recruiting
Oman Salazar 866-856-3259 clinical1@na.amedd.army.mil
David Tribble, MD, DrPH, Principal Investigator
Joyce Lapa, MD, Sub-Investigator
David Tribble, MD, DrPH, Principal Investigator, Naval Medical Research Center
More Information
Last Updated: August 1, 2005
Record first received: July 27, 2005
ClinicalTrials.gov Identifier: NCT00124865
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02

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