Atopic Dermatitis Clinical Trial
Official title:
Responses to Immunization With Keyhole Limpet Hemocyanin Administered by Scarification and the Intradermal Route
Atopic dermatitis (AD) is a skin disorder in which people often have swelling and skin infections. People with this disease cannot receive the smallpox vaccine because it could cause them to have a fatal reaction known as eczema vaccinatum (EV). Keyhole limpet hemocyanin (KLH) is a protein that can be used to deliver vaccines to the body. The purpose of this study is to determine a baseline immune reaction to KLH in people without AD. Once this has been established, other studies can be designed to determine whether KLH can be used to give vaccines to people with AD.
AD is characterized by skin inflammation and recurrent skin infections. In addition, people
with AD may have a severe and sometimes fatal reaction to the smallpox vaccine called EV.
KLH is a carrier protein that can be used to deliver antibodies to the body. However KLH
itself, may cause an immune response. The purpose of this study is to determine the body's
reaction to pure KLH in people without AD. This will be used to establish a baseline immune
response and may be compared to the immune response in people with AD during future studies.
This study will last 8 weeks and will have 11 study visits. Participants in this study will
be randomly assigned to 1 of 4 groups. All participants will receive their immunizations at
Visits 5 and 6. Participants in Group 1A will receive 2 immunizations each with 100 mcg of
KLH each. Participants in Group 2A will receive 2 immunizations through scarification (a
shallow cut in the skin) with jabs, each containing 20 mg/mL of KLH. Adverse reactions will
be monitored after each immunization. Once safety data from these 2 groups have been
reviewed, the next 2 groups will be enrolled. Participants in Group 1B will receive 2
immunizations each with 250 mcg of KLH each. Participants in Group 2B will receive 2
immunizations through scarification with 15 jabs, each containing 20mg/mL of KLH. Other
study visits will include allergy testing and blood and urine collection.
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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