The Uninfected Ixodes Scapularis Human Tick Challenge Model (NCT05965635) | Clinical Trial Compass
CompletedNot Applicable
The Uninfected Ixodes Scapularis Human Tick Challenge Model
Netherlands11 participantsStarted 2023-07-25
Plain-language summary
An innovative way to prevent multiple tick-borne diseases is an anti-tick vaccine, i.e. targeting the vector to prevent transmission of pathogens from the tick to the host. The rationale for an anti-tick vaccine stems from a phenomenon coined tick immunity. This study aims to show proof of concept that humans indeed develop immunity to ticks. Therefore subjects will be challenged three to four times with ticks reared in colony from a designated laboratory and that are exhaustively tested negative for various known tick-borne pathogens. Several tick feeding parameters will be evaluated to assess the development of tick immunity in the subjects. To this end, a total amount of ten ticks per challenge will be placed under a dressing placed on the forearm. The primary study endpoint is the tick feeding phenotype. Secondary parameters are signs of an immune response in the host; itch, redness, or other signs of a (local) immune response (blood and skin biopsies). All parameters, except for the skin biopsies, will be collected/evaluated after each tick challenge.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18 years and older;
* Negative Borrelia VlsE1/pepC10 ELISA.
Exclusion Criteria:
* Known history of tick bites;
* Positive Borrelia serology (VlsE1/PepC10 ELISA);
* Known history or current suspicion on any tick-borne disease;
* Chronic skin condition affecting the arm skin;
* Inability to maintain the dressing for any reason;
* Known immunodeficiency or autoimmune disease;
* Use of systemic immunomodulating drugs or chemotherapy, current or in the past;
* Chronic use of antibiotics;
* Unable to give informed consent or do not have a thorough command of the Dutch language;
* Refusal to participate in specimen collection and storage for future study related use;
* Pregnant or breastfeeding women;
* Not willing to use adequate contraception during the study period;
* Red meat allergy (both medically confirmed and self-reported);
* Use of investigational therapy and devices during the time of the study;
* Any other condition that, in the opinion of the investigator, would make the patient unsuitable for enrolment or could interfere with the patient participating in and completing the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tick weight
Timeframe: Up to 1 week
2
Tick feeding molting success
Timeframe: Up to 1 week
3
Tick survival
Timeframe: Up to 1 week
4
Tick attachment
Timeframe: Up to 1 week
Trial details
NCT IDNCT05965635
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)