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NCT05036707 · ClinicalTrials.gov registry record · Phase 1
Human Immune Response to Ixodes Scapularis Tick Bites
A Phase 1 study of Lyme Disease and Tick-borne Diseases, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05036707: Recruiting Phase 1 study of Lyme Disease and Tick-borne Diseases, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05036707 is a Phase 1 study of Lyme Disease and Tick-borne Diseases that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants, below the 3,868-participant average among 9 other Lyme Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05036707, a Phase 1 study of Lyme Disease and Tick-borne Diseases, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Ongoing assessment of safety.
Conditions Studied
Interventions
- DEVICE Xenodiagnosis Ticks
- PROCEDURE skin biopsy
- PROCEDURE blood draw
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-02-28 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT05036707 shows while recruiting
NCT05036707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 3,868-participant average among 9 other Lyme Disease trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Lyme Disease appearing as the primary indexed condition, and to 3 interventions - of which Xenodiagnosis Ticks is the first listed.
NCT05036707 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05036707 about?
NCT05036707 is a clinical study titled "Human Immune Response to Ixodes Scapularis Tick Bites". 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. Objectiv...
What is the current status of trial NCT05036707?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-02-28. Estimated completion is 2026-06-30.
What conditions does trial NCT05036707 study?
This clinical trial studies the following conditions: Lyme Disease, Tick-borne Diseases, Tick Resistance.
What interventions are being tested in trial NCT05036707?
The interventions under investigation include: Xenodiagnosis Ticks (DEVICE), skin biopsy (PROCEDURE), blood draw (PROCEDURE).
Who is sponsoring clinical trial NCT05036707?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05036707 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05036707's enrollment target sits among peer trials
60 6th of 9 higher than 4 of 9 other Lyme Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lyme Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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