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NotablePrimary and study completion pushed from Jun 30, 2028 to Jun 30, 2029Eligibility criteria expanded, about 46 words · Study description expanded, about 22 words · Publications: details revised at 3 of 3 entriesShow 3 more changesShow less
Eligibility criteria expanded, about 46 words
Study description expanded, about 22 words
Publications: details revised at 3 of 3 entries
NotablePrimary and study completion pushed from Jun 30, 2026 to Jun 30, 2028v26
Minor2 versionsRe-verified since May 17, 2025, no change to tracked fieldsv24-v25
NotablePrimary and study completion dates: Jun 30, 2025 to Jun 30, 2026v23
Show 21 earlier versionsHide 21 earlier versions
Minor3 versionsRe-verified since Jul 31, 2024, no change to tracked fieldsv20-v22
MinorStudy description expanded, about 32 wordsEligibility criteria expanded, about 5 wordsv19Show 1 more changeShow less
NotableStart date changed from estimate of Sep 14, 2021 to Feb 28, 2022Eligibility criteria expanded, about 21 words · Study description expanded, about 685 wordsv3Show 2 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 2-4 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 2-8 weeks apart. For the 2nd and 3rd procedures, 10 clean laboratory-bred ticks will be placed at 1 site. The ticks will be removed 2-3 days after tick placement. 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 5-7 months.