Defining Skin Immunity of a Bite of Key Insect Vectors in Humans (NCT03641339) | Clinical Trial Compass
CompletedNot Applicable
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
United States95 participantsStarted 2018-09-05
Plain-language summary
Background:
Mosquitoes and similar insects called sand flies carry parasites that can cause diseases. These viruses and parasites can spread quickly and be difficult to control. How people s bodies respond to insect bites may affect how they get infected. The response to bites is caused by the immune system, which helps fight off infections. Researchers want to study the immune response in skin to mosquito or sand fly bites and how the response changes after bites on multiple days. This may help researchers develop better vaccines.
Objective:
To study the immune response in skin to certain insect bites and how that changes after bites on multiple days.
Eligibility:
Healthy adults ages 18-64
Design:
Participants will be screened under another protocol. Women must agree to practice effective contraception or abstinence. All participants must agree to not donate blood or use certain lotions or creams on visit days.
Some participants will have 2 visits over a week. Others will have 5 visits over 8 weeks.
All participants will have the following at least once:
Medical history
Physical exam
Blood and urine collected
Mosquito or sand fly feeding. Up to 10 insects will feed on participant s arm for up to 20 minutes. The insects are grown at NIH and do not carry any diseases. The skin will be checked and bites will be treated.
Skin samples taken. The skin will be cleaned and numbed. A tool will remove a small piece of skin from 3 places on the arm.
About a week after the last visit, participants will be called to see how they feel.
Who can participate
Age range
18 Years – 64 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:
Individuals must meet all of the following criteria to be eligible for study participation:
* Healthy women and men who are greater than or equal to 18 and less than or equal to 64 years of age.
* Able to provide informed consent.
* Willingness to complete all study visits and comply with all study requirements.
* Willing to have samples stored for future research.
* A female is eligible for this study if she meets 1 of the following:
* Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
* Of childbearing potential but agrees to practice effective contraception or abstinence for 4 weeks prior to enrollment through the completion of the study. Acceptable methods of contraception include a male partner who is sterile and is the sole sexual partner of the female participant or a male partner who uses a condom with spermicide plus 1 or more of the following that is used by the female: 1) implants of levonorgestrel; 2) injectable progestogen; 3) an intrauterine device with a documented failure rate of \<1%; 4) oral contraceptives; and 5) double barrier method including diaphragm.
* Agrees to not use scented lotions, deodorants, or topical creams on each feeding day.
* Agrees to not take aspirin or any other NSAID within 7 days of a biopsy.
* Agrees to not use topical steroid creams or ointments throughout the study without prior perm…
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
Number of Differentially Expressed Genes Between Bitten (Case) Versus Unbitten (Control) Skin for Each of the Three Vector Groups
Timeframe: Up to 48 hours post bite
2
Participants With Local Skin Adaptive Immune Response After Multiple Exposures Over Time to Bites of Each of the Three Vector Groups
Timeframe: Up to 48 hours post bite
Trial details
NCT IDNCT03641339
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)