Human Immune Response to Ixodes Scapularis Tick Bites

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    60
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 8 October 2021
skin biopsy
blood draw
tick-borne diseases
tick bite
Accepts healthy volunteers

Summary

Background

Each year, the number of cases of tick-borne diseases increases. The deer tick (Ixodes scapularis) is the vector of at least 7 pathogens that cause human diseases, including Lyme disease. Researchers want to learn more to help them develop vaccines against ticks in the future.

Objective

To learn how people s bodies, particularly the skin, respond to tick bites.

Eligibility

Healthy adults aged 18 years and older who have no known history of a tick-borne disease or tick bite exposure.

Design

Participants will be screened with a medical history, physical exam, and blood tests.

Participants will have 2 skin punch biopsies of healthy skin. For this, a sharp instrument will be used to remove a round plug of skin about the size of a pencil eraser. Participants will then have 10 clean laboratory-bred ticks placed at 2 different sites on their skin (20 ticks total). The ticks will be removed from the first site 1 day after placement and from the second site 4 days after placement. Participants will complete symptom diary cards. They will answer questions about itching at the tick feeding sites. They will give blood samples. Photos will be taken of the tick feeding sites. Skin punch biopsies will be collected at the sites of the tick bites.

Participants will repeat the tick feeding procedures 2 times, each 4-6 weeks apart. They will have telephone follow-up visits after each procedure.

After the final tick removal, participants will have follow-up visits in 4-6 weeks and again in 3 months. They will give blood samples and discuss how they are feeling.

Participation will last about 7 months.

Description

Tick-borne diseases (TBDs) are a serious public health problem in the US. Immune responses to multiple tick bites or multiple tick exposures can induce tick-resistance (manifested by reduced numbers and body weights of engorged ticks or tick death in subsequent infestations) in animal models and consequently protection against Borrelia burgdorferi transmission. Similar findings are seen in humans, but little is known about the nature of the protective immune response. Here we propose to combine our expertise to study the response to tick bites in a well standardized clinical setting to identify critical aspects of the human innate and adaptive immune responses in skin and blood following exposure to uninfected Ixodes scapularis ticks; and monitor the acquisition of a tick-associated skin immunity, including itch. This research could lead to the identification of tick salivary proteins that are targets of host immunity and might serve as targets for an anti-tick vaccine. With the current rise of tick-borne diseases in the United States and around the world, we hope the results of this study will contribute to future vaccine design and clinical development strategies for tick-borne diseases.

Details
Condition Tick Resistance, Tick-Borne Disease, tick-borne diseases, Lyme Disease, Lyme Disease Vaccine
Treatment Blood draw, Skin Biopsy, Xenodiagnosis Ticks
Clinical Study IdentifierNCT05036707
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on8 October 2021

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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