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Immune Response Study for Tick Bites

Phase 1 & 2
Recruiting
Led By Adriana R Marques, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimum hemoglobin of 13.0 g/dL for males and 12 g/dL for females
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continous
Awards & highlights

Study Summary

This trial will help researchers learn more about how people's bodies respond to tick bites, which could lead to the development of vaccines against ticks in the future.

Who is the study for?
Healthy adults over 18, with blood group B or AB and normal IgE levels, who've never had a tick-borne disease or known tick bite. They must be willing to follow the study procedures for about 5-7 months and use effective contraception. Excluded are those with severe allergies, skin conditions, uncontrolled diabetes, cancer requiring immunosuppression (except non-melanoma skin cancers), HIV, chronic viral hepatitis, syphilis, history of severe allergic reactions to insect venom or drugs.Check my eligibility
What is being tested?
The trial is studying how human skin responds to deer tick bites. Participants will undergo multiple sessions where lab-bred ticks are placed on their skin and later removed after a few days. Skin biopsies before and after tick placement as well as blood samples will be taken periodically throughout the study.See study design
What are the potential side effects?
Possible side effects include local reactions at the biopsy site such as pain or scarring; itching at the tick feeding sites; allergic reactions to tape/adhesives used in dressing; excessive bleeding due to biopsies especially in individuals with bleeding disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hemoglobin level is at least 13.0 g/dL if I am male, or 12 g/dL if I am female.
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I am 18 years old or older.
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I have never had TBD.
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I have been using effective birth control and agree to continue for 3 months after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuous
This trial's timeline: 3 weeks for screening, Varies for treatment, and continuous for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of Safety of the device. Use toxicity tables and safety monitoring as specified in the protocol.
Develop a model of acquired tick resistance in humans. Use validated pruritus scales, numerical rating system, verbal rating system, and visual analogue system.
Secondary outcome measures
Exploratory: Analyze gene expression of Ixodes scapularis after feeding on humans using RNASeq.
Exploratory: Analyze the evolution of the systemic immune response to tick bite by measuring antibodies response (ELISA and western blot) against Ixodes scapularis salivary protein antigens.
Exploratory: Compare early and late immune response in skin after Ixodes scapularis bite. Use RNASeq, histology, immunohistochemistry, digital spatial profiling to explore.
+1 more

Trial Design

1Treatment groups
Active Control
Group I: 1Active Control3 Interventions
Healthy Volunteer

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,266 Previous Clinical Trials
5,484,037 Total Patients Enrolled
Adriana R Marques, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
9 Previous Clinical Trials
2,711 Total Patients Enrolled

Media Library

1 Clinical Trial Eligibility Overview. Trial Name: NCT05036707 — Phase 1 & 2
Tick-borne Diseases Research Study Groups: 1
Tick-borne Diseases Clinical Trial 2023: 1 Highlights & Side Effects. Trial Name: NCT05036707 — Phase 1 & 2
1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05036707 — Phase 1 & 2
Tick-borne Diseases Patient Testimony for trial: Trial Name: NCT05036707 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this research endeavor striving to realize?

"This clinical trial aims to assess the safety of a particular device. Safety monitoring and toxicity tables will be used as per protocol, while its secondary objectives are exploratory in nature. Specifically, these include determining the effects of multiple tick feedings on local immune responses at bite sites; comparing changes between early and late cellular recruitment following 1st and 3rd exposures; analysing how systemic immunity develops after Ixodes scapularis bites by measuring antibody response against salivary protein antigens; and exploring skin biopsies collected at Day 1 & 4 for potential differences in their early-to-late immune reactions. Results from this study"

Answered by AI

To what extent has this research garnered participation?

"Affirmative. Clinicaltrials.gov's records indicate that this medical research, which was initially publicized on September 14th 2021 is actively enrolling participants. 60 people need to be recruited from a single site."

Answered by AI

Are there any available places in this research project for participants?

"Affirmative, clinicaltrials.gov displays that this medical trial is in need of participants. It was first published on September 14th 2021 and has been recently revised on the 8th of the same month. There are 60 vacancies to be filled at one site only."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
Pennsylvania
Virginia
Other
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

Once we travel to your location where do we stay hotel or do you have a campus' ?
PatientReceived 1 prior treatment
How long does the study take? How long do the visits at NIH take? How many visits to NIH will be required? Will NIH reemburse me for gasoline and parking? Will I get the results of the study when it is over?
PatientReceived no prior treatments

Why did patients apply to this trial?

Because I am wondering if this Lyme diseases is effecting my type 2 diabetes.
PatientReceived no prior treatments
Developed auto immune disease that I feel was triggered by limes disease. when I was younger.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. National Institutes of Health Clinical Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
~6 spots leftby Jun 2024