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Completed

NCT Number: NCT01289977

Immune Responses After Human Subject Challenge With Sand Fly Bites

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Human Th1 immune response to specific sand fly salivary proteins

    Time frame: 6-18 months

    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.

Sponsors and collaborators

Lead sponsor

Uniformed Services University of the Health Sciences

Fed

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Immune Responses After Human Subject Challenge With Sand Fly Bites: Exploratory Study for Selection of Potential Leishmania Vaccine Antigen Candidates

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 4, 2011
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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