Status:
COMPLETED
Responses to Immunization With Keyhole Limpet Hemocyanin Administered by Scarification and the Intradermal Route
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Atopic Dermatitis and Vaccinia Network
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
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 fa...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- Healthy and nonatopic as defined by the ADVN Standard Diagnostic Criteria
- Willing to use appropriate forms of contraception
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00614731
Start Date
December 1 2007
End Date
December 1 2008
Last Update
January 11 2017
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206