A Phase 1 interventional study of KLH carrier-protein in Atopic Dermatitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-11.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Basic science
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 25 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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Exclusion Criteria:
Participants will receive a total of two 100 mcg intradermal (ID) KLH carrier-protein immunizations with 1 mg/ml KLH per immunization. Immunizations will be given 21 days apart at Visits 5 and 6.
Biological: KLH carrier-protein
Participants will receive two scarification immunizations by 3 jabs containing 20 mg/ml of KLH carrier-protein. The immunizations will occur 21 days apart at Visits 5 and 6.
Biological: KLH carrier-protein
Enrollment will begin after the safety data for Groups 1A and 2A have been reviewed. Participants in this group will receive two 250 mcg ID KLH vaccinations containing 10 mg/ml of KLH carrier-protein. Immunizations will occur 21 days apart at Visits 5 and 6.
Biological: KLH carrier-protein
Enrollment will begin after the safety data from groups 1A and 2A has been examined. Participants in this group will receive a total of two scarification immunizations by 5 needles used to administer 15 jabs, each containing, 20 mg/ml of KLH carrier-protein. Immunizations will occur 21 days apart at Visits 5 and 6.
Biological: KLH carrier-protein
KLH carrier-protein vaccination containing no other protein or antibodies
Also known as: Immucothel, Vacmune
Change in anti-KLH IgG antibody response to two vaccinations of KLH in nonatopic participants
Time frame: At baseline and Day 47
Safety of administering KLH by scarification route as measured by proportion of subjects with any treatment-emergent abnormalities in vital signs (body temperature, heart rate, respirations, and blood pressure) and liver function
Time frame: Throughout study
Change in anti-KLH antibody responses in IgG subclasses 1 to 4, IgA, IgM, and IgE.
Time frame: At baseline and Day 47
Incidence of all adverse events (AEs)
Time frame: Throughout study
Change in diameter of delayed type hypersensitivity (DTH) responses to KLH
Time frame: At Day 2 and 49
Induction of a T cell response as measured by a change from negative (smaller than 5 mm) to positive (5 mm or larger) DTH reaction.
Time frame: At Days 2 and 49
Presence or absence of antibody response as measured by whether or not there is a greater than 2 fold increase in antibody (IgG, IgA, IgM, IgE) titers to two administrations of KLH.
Time frame: At Days 0 and 47
Changes pre- versus post-administration of KLH in quantitative levels of clinical labs (CBC, liver function [AST, ALT], renal function [creatinine, BUN])
Time frame: At Days 0 and 47
Changes pre- versus post-administration of KLH in quantitative levels of vital signs (body temperature, heart rate, respirations, blood pressure)
Time frame: At Days 0 and 47
Plan to share: Yes — Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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National Institute of Allergy and Infectious Diseases (NIAID)