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New treatment option for Tick-borne Diseases
Official title Human Immune Response to Ixodes Scapularis Tick Bites
ClinicalTrials.gov ID: NCT05036707
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99. Healthy volunteers may be eligible.
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
- History of allergic reaction to tape, adhesive bandages, or dressings.
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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.
- No known tick bite.
- Serum IgE level within Clinical Center Department of Laboratory Medicine normal range. https://ccinternal2.cc.nih.gov/LTGRA/UL/public\_labtest\_detail.aspx?next\_flg=Y\&test\_id=4731\&id\_order=53
- Serum tryptase level within Clinical Center Department of Laboratory Medicine normal range. https://ccinternal2.cc.nih.gov/LTGRA/UL/public\_labtest\_detail.aspx?next\_flg=Y\&test\_id=1157\&id\_order=1
- 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...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
- Agree to not participate in other clinical studies requiring investigational interventions for the duration of the study.
- 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:
- 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.
- History of allergic reaction to tape, adhesive bandages, or dressings.
- Inability to maintain the dressing for any reason.
- Pregnancy or lactation.
- Treatment with another investigational drug or other intervention within the past 30 days.
- 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).
- History of reactions to mammalian meat, IgE- mediated food allergies, urticaria or anaphylaxis. Mild pollen-food allergy syndrome is not an exclusion.
- History of systemic allergic reaction to venom (bee, wasps and other Hymenoptera stings).
- History of clinically significant drug allergies.
- History of moderate to severe atopy asthma, atopic dermatitis, allergic rhinitis.
- 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...
- Refusal to allow storage of samples and data for future usage..
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.