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Immune Responses After Human Subject Challenge With Sand Fly Bites

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Uniformed Services University of the Health Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT01289977
First received: February 3, 2011
Last updated: March 2, 2011
Last verified: February 2011
History of Changes
  Purpose

Sand flies can carry the infection leishmaniasis (a parasite). The purpose of this study is to evaluate the human immune response to uninfected laboratory raised sand fly bites and select from the immune response to sand fly saliva, possible substances to use for a future vaccine to protect against the parasite leishmaniasis.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Responses After Human Subject Challenge With Sand Fly Bites: Exploratory Study for Selection of Potential Leishmania Vaccine Antigen Candidates

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • Human Th1 immune response to specific sand fly salivary proteins [ Time Frame: 6-18 months ] [ Designated as safety issue: No ]
    Subject blood will be obtained at set points after repeated controlled sand fly feedings, duration for 20 minutes. Sand fly salivary molecules that demonstrate a strong Th1 immune response in these human PBMC, and little Th2 cytokine induction will be considered for development as future leishmania vaccine antigen candidates.


Biospecimen Retention:   Samples With DNA

Plasma and white blood cells will be retained.


Estimated Enrollment: 68
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Phlebotomus group
Those in the Phlebotomus group will have exposure to P. duboscqui sand fly
Lutzomyia group
Those placed in this group will receive exposure to L. longipalpis sand fly bites.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Male and female military health care beneficiaries in good health, age 18-50

Criteria

Inclusion Criteria:

  • Age 18-50
  • Plans to remain in DC area for at least one year
  • willingness to participate in all study procedures
  • general good health
  • military health care beneficiary
  • able to provide informed consent

Exclusion Criteria:

  • Prior travel to geographic areas where leishmania transmitting sand flies are common
  • positive antibody to sand fly saliva on screening blood test
  • pregnancy
  • elevated serum IgE
  • history of chronic medical illness
  • adult history of treatment requiring anemia
  • large reactions to insect bites
  • history of multiple vasovagal reactions to phlebotomy
  • difficult venous access for phlebotomy
  • Taking medications that could interfere with immune responses
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289977

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

No publications provided

Responsible Party: Naomi Aronson MD, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT01289977     History of Changes
Other Study ID Numbers: G183ZU, Y1-AI-0744-01
Study First Received: February 3, 2011
Last Updated: March 2, 2011
Health Authority: United States: Federal Government

Keywords provided by Uniformed Services University of the Health Sciences:
Sandfly
leishmaniasis
immune response
individuals age 18-50

ClinicalTrials.gov processed this record on May 16, 2013