Responses to Immunization With Keyhole Limpet Hemocyanin Administered by Scarification and the Intradermal Route

Completed · Phase 1

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT00614731

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

25

Starts

2007-12-01

Expected to finish

2008-12-01

Last updated by the study team

2017-01-11

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy and nonatopic as defined by the ADVN Standard Diagnostic Criteria
• Willing to use appropriate forms of contraception

You may not qualify if…

• Active bacterial, viral, or fungal infection within 30 days prior to study entry
• Immunodeficiency
• Received Use of systemic corticosteroids, antibiotics, antivirals, anti-inflammatory biologics (e.g., alefacept, etanercept), calcineurin inhibitors, oral immunosuppressive agents, anxiolytic agents, antidepressants, or cancer chemotherapy within 30 days prior to KLH administration
• Use of topical corticosteroids, antibiotics, antivirals, immune enhancers, or calcineurin inhibitors within 7 days prior to study entry
• Allergy to shellfish
• Vaccination within 30 days prior to entering the study
• Skin rash
• Participation in a clinical trial within 4 weeks of study entry
• Positive response to DTH test prior to administration of KLH
• Previous exposure to KLH or products containing KLH
• Allergic or hypersensitivity to KLH
• Any condition that, in the opinion of the investigator, would interfere with the study
• Pregnant or breastfeeding

Where it is running

• National Jewish Health — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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