An observational study in Healthy, sponsored by Uniformed Services University of the Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Uniformed Services University of the Health Sciences · Observational
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.
Based on travel history and possible exposure, subjects were entered into one of 2 arms, Ph. dubosqui or Lu. lutzomyia controlled sand fly repeated feedings. At baseline a pheresis was done to collect baseline cells. Subjects received sand fly bites on a q2 week schedule for 2 months followed by a q2 months schedule for one year. They had an option to extend for a late recall feeding at 18 months, when a skin biopsy was performed 48 hours after sand fly bites. Currently the study is fully enrolled and all human subject contact is complete. We (laboratory at NIAID) are studying the humoral, cellular immune responses using blood samples, and cytokine expression in the skin biopsy samples.
Uniformed Services University of the Health Sciences is the lead sponsor of 45 studies on the registry; 13 are open to participants now.
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Male and female military health care beneficiaries in good health, age 18-50
Exclusion Criteria:
Those in the Phlebotomus group will have exposure to P. duboscqui sand fly
Those placed in this group will receive exposure to L. longipalpis sand fly bites.
Human Th1 immune response to specific sand fly salivary proteins
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.
Time frame: 6-18 months
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Uniformed Services University of the Health Sciences