Actively Recruiting
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
330 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Human Immune Response to Ixodes Scapularis Tick Bites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to comply with all study procedures and be available for the full study duration
- Age 18 years or older
- In good general health based on medical history
- No history of tick-borne disease
- No known tick bite exposure
- Serum IgE level within normal range
- Serum tryptase level within normal range
- For participants who can bear children: effective contraception use for at least 1 month before tick placement and during the study plus 3 months after last tick removal
- For males with reproductive potential: use of condoms or other effective contraception methods with partner
- Agree not to participate in other clinical studies with investigational interventions during this study
- Minimum hemoglobin of 13.0 g/dL for males and 12 g/dL for females
You will not qualify if you...
- History of forming large thick scars (keloids) after skin injuries
- History of excessive bleeding after cuts or procedures
- Use of anticoagulants in the past 28 days
- Allergic reaction history to lidocaine
- Allergic reaction history to tape, adhesive bandages, or dressings
- Inability to maintain the dressing
- Pregnancy or lactation
- Treatment with another investigational drug or intervention within the past 30 days
- Use of oral or intravenous steroids within 2 weeks before each tick placement (topical, nasal, inhaled, intra-articular, and replacement doses are allowed)
- History of reactions to mammalian meat, IgE-mediated food allergies, urticaria or anaphylaxis (mild pollen-food allergy syndrome is allowed)
- History of systemic allergic reaction to venom from bees, wasps, or other stings
- History of clinically significant drug allergies
- History of moderate to severe atopic asthma, atopic dermatitis, or allergic rhinitis
- Active severe skin disease, uncontrolled diabetes, cancer other than non-melanoma skin cancers, autoimmune disease needing immunosuppressive therapy, or history of HIV, chronic viral hepatitis, or syphilis
- Refusal to allow storage of samples and data for future use
- Any other condition making participation unsuitable or interfering with study completion as judged by the investigator
- Children, pregnant and breastfeeding women, and adults lacking decision-making capacity are excluded
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Siu-Ping Ng, R.N.
CONTACT
A
Adriana R Marques, M.D.
CONTACT
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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