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Immune Response Study for Tick Bites

Phase 1 & 2

Recruiting

Led By Adriana R Marques, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age 18 years or older

Must not have

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

History of taking anticoagulants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up continous

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn more about how people's bodies respond to tick bites, which could lead to the development of vaccines against ticks in the future.

Who is the study for?

Healthy adults over 18, with blood group B or AB and normal IgE levels, who've never had a tick-borne disease or known tick bite. They must be willing to follow the study procedures for about 5-7 months and use effective contraception. Excluded are those with severe allergies, skin conditions, uncontrolled diabetes, cancer requiring immunosuppression (except non-melanoma skin cancers), HIV, chronic viral hepatitis, syphilis, history of severe allergic reactions to insect venom or drugs.

What is being tested?

The trial is studying how human skin responds to deer tick bites. Participants will undergo multiple sessions where lab-bred ticks are placed on their skin and later removed after a few days. Skin biopsies before and after tick placement as well as blood samples will be taken periodically throughout the study.

What are the potential side effects?

Possible side effects include local reactions at the biopsy site such as pain or scarring; itching at the tick feeding sites; allergic reactions to tape/adhesives used in dressing; excessive bleeding due to biopsies especially in individuals with bleeding disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hemoglobin level is at least 13.0 g/dL if I am male, or 12 g/dL if I am female.

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I am 18 years old or older.

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I have never had TBD.

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I have been using effective birth control and agree to continue for 3 months after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe skin conditions, uncontrolled diabetes, other cancers, autoimmune diseases needing strong immune system medications, or a history of HIV, chronic hepatitis, or syphilis.

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I have a history of taking blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuous

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~continuous

This trial's timeline: 3 weeks for screening, Varies for treatment, and continuous for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

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.

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

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