Human Immune Response to Ixodes Scapularis Tick Bites

 The aim of this study is to learn how peoples’ bodies, particularly the skin, respond to tick bites.

What does the study involve?

During this study, participants are asked to have 10 clean laboratory-bred ticks placed at 2 different sites on their skin (20 ticks total).

• 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.
• 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 to answer questions about itching at the tick feeding sites.
• Participants will give blood samples, photos will be taken of the tick feeding sites, and 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 up to 7 months with continuous engagement via phone, email, and text.

Who Can Participate?

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

Where Is It Taking Place?

The National Institutes of Health Clinical Center in Bethesda, MD.

Is There a Cost?

There is no cost to the participant.

Is Compensation Provided?

Compensation is provided.

Number of Visits

12 in-person visits in addition to telephone calls.

Steps To Participate

To learn more about the study, visit NCT05036707 or call us at (301) 435-7244.  You may also reach us through email at LymeDxStudies@niaid.nih.gov .

Visit ClinicalTrials.gov for details.