Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05036707
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact Carla D Williams, R.N.
Phone (301) 443-9460
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date September 14, 2021
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04318925 - Evaluation and Follow-up of People With Tick-borne Diseases
Completed NCT01207739 - Persistent Lyme Empiric Antibiotic Study Europe Phase 4
Active, not recruiting NCT04577053 - PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics N/A
Recruiting NCT04038346 - Symptomatic Management of Lyme Arthritis Phase 3
Completed NCT01143558 - Searching for Persistence of Infection in Lyme Disease Early Phase 1
Completed NCT03581279 - Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel N/A
Enrolling by invitation NCT05041595 - Lyme Disease Diagnostic Assay - Collection of Whole Blood
Recruiting NCT03981874 - Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children N/A
Recruiting NCT04867473 - Feasibility of Teleyoga for Treatment of Lyme Disease N/A
Recruiting NCT03963635 - Novel Diagnostics for Early Lyme Disease
Terminated NCT03084614 - CD8 Reactivity to Microorganisms in Blood and Breast Milk
Recruiting NCT04835792 - Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Recruiting NCT04148222 - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
Terminated NCT03201042 - Lyme Test Indication Combinations (LyTIC) Study
Completed NCT01368341 - Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice Phase 4
Terminated NCT00958139 - Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes Phase 3
Recruiting NCT00001539 - A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
Recruiting NCT03501407 - Understanding Tick-borne Diseases
Recruiting NCT04422314 - ImmuneSense Lyme Study
Recruiting NCT03505879 - Next Generation Sequencing Detection of Lyme Disease