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Protocol Details

Investigating the Human Immune Response to Ixodes scapularis Tick Bites

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required


Population Exclusion(s)

Non-English Speaking;


Tick Immunity;
Tick-borne diseases;
Lyme Disease

Recruitment Keyword(s)



Tick-borne diseases;
Tick resistance;
Lyme Disease

Investigational Drug(s)


Investigational Device(s)

Xenodiagnosis Ticks


Device: Xenodiagnosis Ticks
Procedure/Surgery: skin biopsy
Procedure/Surgery: blood draw

Supporting Site

National Institute of Allergy and Infectious Diseases


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.


To learn how people s bodies, particularly the skin, respond to tick bites.


Healthy adults aged 18 years and older who have no known history of a tick-borne disease or tick bite exposure.


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.

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In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Stated willingness to comply with all study procedures and availability for the duration of the study.

2. Age 18 years or older.

3. In good general health as evidenced by medical history.

4. No history of TBD.

5. No known tick bite.

6. Serum IgE level within Clinical Center Department of Laboratory Medicine normal range.

7. Serum tryptase level within Clinical Center Department of Laboratory Medicine normal range.

8. For participants of child-bearing potential: use of effective contraception for at least 1 month prior to tick placement, and agreement to use such a method during study participation and for an additional 3 months after the removal of the last ticks. Types of contraception include abstinence, surgical methods (sterilization, implants, intrauterine device, partner with vasectomy), hormonal methods (birth control pill, patch, ring, injection), or barrier methods (diaphragm plus spermicide, male condom plus spermicide)

9.For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

10.Agree to not participate in other clinical studies requiring investigational interventions for the duration of the study.

11. Minimum hemoglobin of 13.0 g/dL for males and 12 g/dL for females


An individual who meets any of the following criteria will be excluded from participation in this study:

1. History of forming large thick scars (keloids) after skin injuries.

2. History of excessive bleeding after cuts or procedures.

3. History of taking anticoagulants.

4. History of allergic reaction to lidocaine.

5. History of allergic reaction to tape, adhesive bandages, or dressings.

6. Inability to maintain the dressing for any reason.

7. Pregnancy or lactation.

8. Treatment with another investigational drug or other intervention within the past 30 days.

9. Oral or intravenous (IV) steroids in the 2 weeks prior to each tick placement procedure (topical, nasal, inhaled, intra-articular, and replacement doses of steroids are not exclusions).

10. History of reactions to mammalian meat, IgE- mediated food allergies, urticaria or anaphylaxis. Mild pollen-food allergy syndrome is not an exclusion.

11. History of systemic allergic reaction to venom (bee, wasps and other Hymenoptera stings).

12. History of clinically significant drug allergies.

13. History of moderate to severe atopy asthma, atopic dermatitis, allergic rhinitis.

14. Active severe skin disease, uncontrolled diabetes, cancer other than non-melanoma skin cancers, autoimmune disease requiring immunosuppressive therapy, or history of human immunodeficiency virus (HIV), chronic viral hepatitis, or syphilis.

15. Refusal to allow storage of samples and data for future usage..

16. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in and completing the study.

Exclusion of Select Populations:


Children are excluded from this protocol as there is no direct benefit to the participants, the risk from the skin biopsies is small but above minimal, the procedure is invasive and can be stressful for children, and there is concern over their ability to maintain the LeFlap dressing.

Pregnant and breastfeeding women:

Pregnant and breastfeeding women are excluded from trial participation as there is no direct benefit to the participants.

Adults who lack capacity to consent:

Adults lacking decision-making capacity to provide informed consent are excluded at screening as there is no direct benefit to the participants.

Enrolled participants who permanently lose the ability to consent during participation will be monitored for safety but will have no additional research procedures performed.

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Marques A, Telford SR 3rd, Turk SP, Chung E, Williams C, Dardick K, Krause PJ, Brandeburg C, Crowder CD, Carolan HE, Eshoo MW, Shaw PA, Hu LT. Xenodiagnosis to detect Borrelia burgdorferi infection: a first-in-human study. Clin Infect Dis. 2014 Apr;58(7):937-45. doi: 10.1093/cid/cit939. Epub 2014 Feb 11. PMID: 24523212; PMCID: PMC3952603.

Ribeiro JM, Alarcon-Chaidez F, Francischetti IM, Mans BJ, Mather TN, Valenzuela JG, Wikel SK. An annotated catalog of salivary gland transcripts from Ixodes scapularis ticks. Insect Biochem Mol Biol. 2006 Feb;36(2):111-29. doi: 10.1016/j.ibmb.2005.11.005. Epub 2005 Dec 20. PMID: 16431279.

Valenzuela JG. Exploring tick saliva: from biochemistry to 'sialomes' and functional genomics. Parasitology. 2004;129 Suppl:S83-94. doi: 10.1017/s0031182004005189. PMID: 15938506.

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Principal Investigator

Referral Contact

For more information:

Adriana R. Marques, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
(301) 435-7244

Siu-Ping Turk, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 9N228
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7661

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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