Xenodiagnosis to detect Borrelia burgdorferi infection: a first-in-human study.
Adriana Marques, Sam R Telford, Siu-Ping Turk...
https://pubmed.ncbi.nlm.nih.gov/24523212/Actively Recruiting
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-06
60
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying how the human body, especially the skin, responds to bites from the deer tick Ixodes scapularis, which can carry diseases like Lyme disease. The goal is to develop a model of acquired tick resistance and to better understand immune reactions to tick bites. This prospective, non-randomized study involves healthy adult volunteers without prior tick-borne disease or tick bite exposure. Participants will undergo up to three tick feeding procedures spaced 2 to 8 weeks apart. In the first procedure, 20 laboratory-bred ticks are placed at two sites on the skin, with ticks removed after 1 day at one site and 2 to 4 days at the other. For the second and third procedures, 10 ticks are placed at one site and removed after 2 to 3 days. Skin punch biopsies and blood samples will be collected at different time points to examine immune responses and changes in tick gene expression. During the 5 to 7 months of participation, volunteers will complete symptom diaries, answer questions about itching, and attend follow-up visits including phone calls after each tick feeding. Researchers will take photos, collect skin biopsies, and monitor blood samples to assess local and systemic immune reactions. Safety will be closely monitored, and follow-up visits will occur 4 to 6 weeks and 3 months after final tick removal to discuss health and analyze blood samples.
CONDITIONS
Human Immune Response to Ixodes Scapularis Tick Bites
S
Siu-Ping Ng, R.N.
A
Adriana R Marques, M.D.
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Investigational Protocol: Xenodiagnosis with Laboratory-Reared Ixodes Scapularis and Biopsies | Current Evaluation: Symptom- and History-Based Clinical Assessment |
|---|---|---|
| What it is | Controlled exposure to laboratory-reared Ixodes scapularis (black-legged) tick larvae under medical supervision, with sequential sampling of skin and blood to evaluate immune responses. | Diagnosis based on clinical assessment of tick exposure history, symptoms, and signs. No routine laboratory tick exposure or protocol-guided tissue sampling is involved. |
| Role in study/clinical care | Used to model and directly assess the human immune response to controlled tick bites, aiming to characterize biological markers of tick resistance. | Clinical evaluation aims to identify local or systemic reactions after suspected tick bite and determine need for additional monitoring or management. |
| Primary use or purpose | Experimental assessment of innate and adaptive immune responses, pruritus, and the development of tick resistance in healthy adults using standardized exposure and biopsies. | Used to clinically identify adverse reactions to tick bites and to guide management for suspected or confirmed cases. |
| How it is given or performed | Larval ticks are applied to the skin under sterile conditions. Tissue (skin punch biopsy) and blood samples are collected at defined intervals for immune analysis. | Clinical evaluation involves physical examination, symptom inquiry, and, when indicated, supportive laboratory tests (e.g., allergy testing), but no deliberate tick exposure or planned skin biopsies. |
| Evidence status | Pilot human studies show that xenodiagnosis can be used to study immune response to tick feeding, but the approach has not been validated for clinical diagnosis of tick resistance; results specific to this trial are not yet available. | Clinical assessment remains the standard for evaluating tick-bite reactions and diagnosing possible allergic or immune-mediated responses in practice. |
| Important limitations | Requires deliberate tick placement and skin biopsies, which may carry procedural risks and discomfort. Not validated as a clinical diagnostic test, and findings may not translate directly to the general population or those with preexisting tick-borne diseases. | Clinical assessment may miss subtle or subclinical immune responses and cannot directly measure acquired resistance or specific immune pathways. No standardized laboratory or tissue-based diagnostic exists. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 24 weeks
Participants undergo up to 3 tick feeding placements, spaced 2 to 8 weeks apart. Skin biopsies from the tick bite sites and blood samples are collected at specified timepoints after each tick placement to monitor immune response and tick gene expression.
Up to 9 visits for tick placements and biopsies plus blood draws
Duration - Up to study completion (approximately 6 months)
Participants are monitored for safety and development of tick resistance through clinical assessments including pruritus scoring, site reactions, and measurement of immune responses over the course of the study.
Regular monitoring visits as needed
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Adriana Marques, Sam R Telford, Siu-Ping Turk...
https://pubmed.ncbi.nlm.nih.gov/24523212/José M C Ribeiro, Francisco Alarcon-Chaidez, Ivo M B Francischetti...
https://pubmed.ncbi.nlm.nih.gov/16431279/J G Valenzuela
https://pubmed.ncbi.nlm.nih.gov/15938506/National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor