drugset / Trial / NCT00614731
Responses to Immunization With Keyhole Limpet Hemocyanin Administered by Scarification and the Intradermal Route
Phase 1
Completed
25 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Atopic Dermatitis and Vaccinia Network · collab
RandomizedParallel-groupOpen-labelBasic science
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 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.
Timeline
- Start
- 2007-12
- Primary completion
- 2008-12
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | keyhole limpet hemocyanin | Vaccine | 50 ug | Intravenous |
| Subject | keyhole limpet hemocyanin | Vaccine | 100 ug | Intravenous |
| Subject | keyhole limpet hemocyanin | Vaccine | 250 ug | Intravenous |
| Subject | keyhole limpet hemocyanin | Vaccine | 1 mg/ml | Intravenous |
| Subject | keyhole limpet hemocyanin | Vaccine | 10 mg/ml | Intravenous |
| Subject | keyhole limpet hemocyanin | Vaccine | 20 mg/ml | Intravenous |