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NCT03641339 · ClinicalTrials.gov registry record · NA
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
A NA study of Malaria and Dengue, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 95
- Enrollment target
- 1
- Study location
NCT03641339: Completed NA study of Malaria and Dengue, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03641339 is a NA study of Malaria and Dengue that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 95 participants, below the 255-participant average among 27 other Malaria trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03641339, a NA study of Malaria and Dengue, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 95 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of differentially expressed genes between bitten and unbitten skin with adjusted p-values (adjusted for multiple comparisons) of \< 0.05 and a minimum absolute fold change \> 4 in samples derived from skin biopsies for the three vector groups - Aedes aegypti, Anopheles gambiae, Lutzomyia longipalpis
Conditions Studied
Interventions
- OTHER One vector feeding
- OTHER Four vector feeding
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2020-05-20 |
| Phase | NA |
What the finished NCT03641339 record still lists
NCT03641339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 255-participant average among 27 other Malaria trials with a reported enrollment target (63% lower).
The record links to 5 conditions, with Malaria appearing as the primary indexed condition, and to 2 interventions - of which One vector feeding is the first listed.
NCT03641339 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03641339 about?
NCT03641339 is a clinical study titled "Defining Skin Immunity of a Bite of Key Insect Vectors in Humans". 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 immu...
What is the current status of trial NCT03641339?
This trial is currently completed. It is a NA study. The enrollment target is 95 participants. The study started on 2018-09-05. Estimated completion is 2020-05-20.
What conditions does trial NCT03641339 study?
This clinical trial studies the following conditions: Malaria, Dengue, Zika, Leishmaniasis, Chikungunya.
What interventions are being tested in trial NCT03641339?
The interventions under investigation include: One vector feeding (OTHER), Four vector feeding (OTHER).
Who is sponsoring clinical trial NCT03641339?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03641339 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03641339's enrollment target sits among peer trials
95 12th of 27 higher than 16 of 27 other Malaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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