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Intranasal rFla-MBP Vaccine Dose-Ranging - Article


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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

Sponsored by: U.S. Army Office of the Surgeon General
Information provided by: Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier: NCT00124865

Purpose

An open-labeled does escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses.
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

Further Study Details: 
Primary Outcomes: Local and systemic reactions; Mucosal immunogenicity; Systemic immunogenicity
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

Ages Eligible for Study:  18 Years   -   40 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00124865

Oman Salazar      866-856-3259    clinical1@na.amedd.army.mil
Felicia Breedy      866-856-3259    clinical2@na.amedd.army.mil

Maryland
      Walter Reed Army Institute of Research, Silver Spring,  Maryland,  20910,  United States; Recruiting
Felicia Breedy  866-856-3259    clinical2@na.amedd.army.mil 
Oman Salazar  866-856-3259    clinical1@na.amedd.army.mil 
David Tribble, MD, DrPH,  Principal Investigator
Joyce Lapa, MD,  Sub-Investigator

Study chairs or principal investigators

David Tribble, MD, DrPH,  Principal Investigator,  Naval Medical Research Center   

More Information

Study ID Numbers:  0949; 2002.0003; A-11697; rFla-MBP
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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