Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 99Years
All Genders
Healthy Volunteers
ID05036707

Investigating the Human Immune Response to Ixodes Scapularis Tick Bites

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

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AI-Summary

What this Trial Is About

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

Brief Title

Human Immune Response to Ixodes Scapularis Tick Bites

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing to comply with all study procedures and available for the duration of the study
  • Age 18 years or older
  • In good general health based on medical history
  • No history of tick-borne disease
  • No known previous tick bite
  • Normal serum IgE level
  • Normal serum tryptase level
  • Use of effective contraception if of child-bearing potential before and during the study plus 3 months after last tick removal
  • Males of reproductive potential must use condoms or other contraception
  • Agree not to participate in other clinical studies with investigational interventions during the study
  • Minimum hemoglobin of 13.0 g/dL for males and 12 g/dL for females
Not Eligible

You will not qualify if you...

  • History of forming large thick scars (keloids)
  • History of excessive bleeding after cuts or procedures
  • Use of anticoagulants within the past 28 days
  • Allergic reaction to lidocaine
  • Allergic reaction to tape, adhesive bandages, or dressings
  • Unable to keep dressing in place
  • Pregnancy or breastfeeding
  • Treatment with other investigational drugs or interventions within past 30 days
  • Oral or IV steroids within 2 weeks before tick placement (except topical, nasal, inhaled, intra-articular, or replacement doses)
  • History of reactions to mammalian meat, severe food allergies, urticaria or anaphylaxis
  • History of systemic allergic reaction to venom (bee, wasps, or other stings)
  • History of significant drug allergies
  • History of moderate to severe asthma, atopic dermatitis, or allergic rhinitis
  • Active severe skin disease, uncontrolled diabetes, cancer (except non-melanoma skin cancers), autoimmune disease needing immunosuppressive therapy, or history of HIV, chronic hepatitis, or syphilis
  • Refusal to allow storage of samples and data for future research
  • Any condition that may interfere with study participation or completion
  • Children, pregnant or breastfeeding women, and adults lacking consent capacity are excluded

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

S

Siu-Ping Ng, R.N.

A

Adriana R Marques, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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