Status:
UNKNOWN
The Uninfected Ixodes Scapularis Human Tick Challenge Model
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Tick Bites
Tick Immunity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-t...
Detailed Description
This will be an, single centre, experimental study. The design of the study is similar to a human challenge trial, with the important exception that the subjects in this study are not experimentally i...
Eligibility Criteria
Inclusion
- Age: 18 years and older;
- Negative Borrelia VlsE1/pepC10 ELISA.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05965635
Start Date
July 1 2023
End Date
July 1 2024
Last Update
July 28 2023
Active Locations (1)
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1
AUMC location AMC
Amsterdam-Zuidoost, North Holland, Netherlands, 1105 AZ