Human Immune Response to Ixodes Scapularis Tick Bites

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Age 18 years or older.

In good general health as evidenced by medical history.

No history of TBD.

Disqualifiers

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

History of excessive bleeding after cuts or procedures.

History of taking anticoagulants in the past 28 days.

History of allergic reaction to lidocaine.

Trial design

Design model

Single group

Treatments tested in this trial

  • Xenodiagnosis Ticks

    Device

    Larval ticks will be obtained from Dr. Sam Telford from a laboratory maintained tick colony at Tufts Veterinary School. These ticks are hatched from eggs laid by ticks that have fed only on specific pathogen free laboratory animals that were purchased from established vendors.

  • skin biopsy

    Procedure/Surgery

    2-3 mm skin punch biopsies will be performed.

  • blood draw

    Procedure/Surgery

    Peripheral blood draws will be performed.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: 1Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Assessment of Safety of the device. Use toxicity tables and safety monitoring as specified in the protocol.

Ongoing assessment of safety.

Time frame
continuous
2

Develop a model of acquired tick resistance in humans. Use validated pruritus scales, numerical rating system, verbal rating system, and visual analogue system.

Clinical measures of tick immunity.

Time frame
end of study

Secondary outcomes

1

Exploratory: Determine the effects of repeated tick feeding on immune response at tick bite site and the development of resistance. Use RNASeq,histology, immunohistochemistry, digital spatial profiling, clinical itch scales, site reactions, tick...

Compare changes in early and late local immune response and cellular recruitment between the 1st and 3rd tick exposures.

Time frame
continuous
2

Exploratory: Analyze gene expression of Ixodes scapularis after feeding on humans using RNASeq.

Measure changes in gene expression of ticks fed at the various time points.

Time frame
continuous
3

Exploratory: Compare early and late immune response in skin after Ixodes scapularis bite. Use RNASeq, histology, immunohistochemistry, digital spatial profiling to explore.

Compare early and late immune response in the skin using skin biopsies collected at Day 1 and Day 4.

Time frame
continuous
4

Exploratory: Analyze the evolution of the systemic immune response to tick bite by measuring antibodies response (ELISA and western blot) against Ixodes scapularis salivary protein antigens.

Compare the development of antibody responses against Ixodes scapularis salivary antigens between the 1st, 2nd, and 3rd tick feedings.

Time frame
continous

Other outcomes

Sponsors and contacts

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