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

This is an interventional basic science trial for Zika focused on measuring Mosquito, Saliva, Immune Response, Sand Fly, Biopsy Read More

• 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 permission of Principal Investigator (PI).
• Vector-specific antibody enzyme-linked immunosorbent assay (ELISA) to one of the three vectors (the one to which the individual is assigned) is <2.5 standard deviations above the negative control for Cohort A only.

EXCLUSION CRITERIA:

Individuals meeting any of the following criteria will be excluded from study participation:

• Any underlying or current medical condition that, in the opinion of the investigator, would interfere with participation in the study.
• Any participant that is HIV positive.
• A clinically significant (as determined by the PI) baseline Grade 1 or greater toxicity by the toxicity table.
• History of severe allergic reaction (including to mosquito or other insect bites) with generalized urticaria, angioedema, anaphylaxis, or anaphylactoid reaction.
• Prone to allergic responses and/or significant history of allergies, including seasonal or specific allergies as determined by the PI.
• Receipt of any investigational drug that is unlicensed within 3 months or 5.5 half- lives (whichever is greater) prior to enrollment.
• Receipt of any unlicensed vaccine within 6 months prior to enrollment.
• Self-reported or known history of alcoholism or drug abuse within 6 months prior to enrollment, or positive urine test for drugs of abuse at screening (excluding positive test for tetrahydrocannabinol (THC) or its metabolites if usage is less than 3 times per week).
• 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, history of abnormal blood clotting, or result outside of the normal laboratory range for measurements of prothrombin time (PT), partial thromboplastin time (PTT), or international normalized ratio (INR) that may suggest a problem with blood clotting.
• History of significant scarring 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.

Co-enrollment Guidelines: Co-enrollment in other trials is restricted, but may take place after consultation with the study staff and approval from the PI.