NCT07479537

Brief Summary

Tick-borne diseases are increasing worldwide, and there are currently few effective ways to prevent them. One promising new strategy is to develop a vaccine that targets the tick itself ("anti-tick vaccine") to block the transmission of multiple pathogens. Some animals naturally develop resistance to ticks after repeated tick bites. There are indications that a similar form of acquired tick resistance (ATR) may also occur in humans who have been heavily exposed to ticks. This study investigates whether humans can naturally develop tick resistance and how this affects tick feeding. The investigators will compare people with a long history of tick bites and self-reported signs of tick resistance to people who are tick-naïve. The investigators will also include a small group of volunteers who previously participated in an experimental human tick challenge to evaluate what their reaction on tickbites is 1-2 years after their initial exposures.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Aug 2025Jun 2026

Study Start

First participant enrolled

August 14, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

December 3, 2025

Last Update Submit

March 15, 2026

Conditions

Keywords

Tick resistance in naturally exposed individualstick resistance in tick-naive individuals

Outcome Measures

Primary Outcomes (1)

  • Tick feeding: tick weight

    Tick weight measured in mg after complete feeding of the tick

    From the start of the tick challenge until feeding to repletion of the ticks (max 10 days)

Secondary Outcomes (5)

  • Tick feeding: tick mortality

    From the start of the tick challenge until feeding to repletion of the ticks (max 10 days)

  • Host reaction: redness

    Redness will be monitored at day 2 and the last day of the tick challenge

  • Host reaction: itch

    Itch is measures daily during the tick challenge (From the start of the tick challenge until feeding to repletion of the ticks (max 10 days)

  • Host immune response: humoral

    From the start of the challenge, day 2, day 5, final day of challenge (day 5-10) depending upon tick feeding, 3-5 weeks after the challenge and 10-12 weeks after the challenge

  • Host immune response: cellular

    From the start of the challenge, day 2, day 5, final day of challenge (day 5-10) depending upon tick feeding, 3-5 weeks after the challenge and 10-12 weeks after the challenge

Study Arms (3)

Tick naive individuals

EXPERIMENTAL

Individuals who have never been bitten by ticks before (as far as known)

Other: Tick challenge

Supposed tick immune individuals

EXPERIMENTAL

Individuals who have been bitten by a lot of ticks before and experience a local reaction after each tickbite.

Other: Tick challenge

Previous TICK ME participants

EXPERIMENTAL

Individuals who have participated in the TICK ME study

Other: Tick challenge

Interventions

uninfected ixodes scapularis ticks will be placed underneath a closed dressing

Previous TICK ME participantsSupposed tick immune individualsTick naive individuals

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Naturally acquired self-reported tick resistant individuals:
  • Age: 18 - 70 years;
  • History of repeated tick bites
  • Local reaction (like redness or itch) at place of previous tick bites and/or signs of impaired tick feeding after bite (anamnestic)
  • Controls:
  • Age: 18 years - 70 years;
  • Experimentally acquired tick resistant individuals:
  • Previous participant in the TICK ME study that has completed all 4 challenges
  • Age: 18 years - 70 years;

You may not qualify if:

  • Current suspicion of any tick-borne disease
  • Diagnosed with tick-borne disease within the last year
  • Chronic skin condition affecting the skin of the arm;
  • 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.
  • Known history of tick bites;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Tick Bites

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Joppe W Hovius, Prof. Dr.

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

December 3, 2025

First Posted

March 18, 2026

Study Start

August 14, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations