Status:
COMPLETED
Characterization of Skin Immunity to Aedes Aegypti Saliva in Dengue-endemic Participants in Cambodia
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Vector Borne Diseases
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Background: Mosquito-borne viruses like dengue cause major illness and death worldwide, particularly in Southeast Asia. When mosquitoes deliver a virus into the skin of humans, they also leave saliva...
Detailed Description
Mosquito-borne viruses continue to cause significant global morbidity and mortality, particularly in Southeast Asia. When mosquitoes deliver the virus into the skin of humans while probing for a blood...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 - 45 years
- Live within approximately 15 km of study site
- In good general health as evidenced by medical history
- Willing to allow biological samples to be 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 \>=1 year).
- -Of childbearing potential but has negative urine pregnancy test on Day 0
- Agrees to not use scented lotions, deodorants, or topical creams on each feeding day.
- Agrees to not take aspirin or any other NSAID (ex. ibuprofen) within 7 days of a biopsy.
- Agrees to not use oral or topical antihistamines or steroid creams or ointments throughout the
- study without prior permission of Principal Investigator (PI).
- EXCLUSION CRITERIA:
- Any underlying or current medical condition that, in the opinion of the investigator, would
- interfere with participation in the study.
- History of severe allergic reaction (including to mosquito or other insect bites) with generalized
- urticaria, angioedema, anaphylaxis, anaphylactoid reaction or any other reaction described by
- the participant and deemed severe by the PI.
- Self-reported or known history of alcoholism or drug abuse within 6 months prior to enrollment
- Self-reported or known history of psychiatric or psychological issues that require treatment and
- are deemed by the PI to be a contraindication to protocol participation.
- Any use of medications that affect blood clotting within 3 months or history of abnormal blood
- clotting
- History of significant scarring such as keloids after previous biopsies, lacerations, abrasions,
- surgeries, or other skin procedures (e.g., cosmetic piercings) that are deemed by the PI to be a
- contraindication to protocol participation.
- Pregnant or breastfeeding.
Exclusion
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04350905
Start Date
October 27 2020
End Date
April 9 2021
Last Update
April 12 2022
Active Locations (1)
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1
Kampong Speu Referral Hoispital
Chbar Mon, Cambodia, 05251