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Defining Skin Immunity of a Bite of Key Insect Vectors in Humans

NCT03641339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2021-12-08

Study results available
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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.

Conditions

  • Zika
  • Dengue
  • Malaria
  • Chikungunya
  • Leishmaniasis

Interventions

OTHER

One vector feeding

Participants will undergo one feeding by one of three colony- reared vectors (Aedes aegypti mosquitos, Anopheles gambiae mosquitos, or Lutzomyia longipalpis sand flies)

OTHER

Four vector feeding

Participants will undergo four feedings by one of three colony- reared vectors (Aedes aegypti mosquitos, Anopheles gambiae mosquitos, or Lutzomyia longipalpis sand flies), each about 2 weeks apart, with the same vector type.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Matthew J Memoli, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2020-05-20
Completion
2020-05-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03641339 on ClinicalTrials.gov