drugset / Trial / NCT01489956
A Study to Determine the Immunogenicity and Oral Tolerance to Keyhole Limpet Hemocyanin (KLH)
Phase 0
Terminated
19 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to test the oral tolerance of Keyhole Limpet Hemocyanin (KLH) and to determine if Immucothel by itself is strong enough to trigger the immune response. If not, Immucothel will be tested in combination with an adjuvant to determine if an adequate immune response can be seen.
Timeline
- Start
- 2011-12
- Primary completion
- 2013-04
- Completion
- 2013-04
Outcome
Outcome not reported
Stopped: “Due to futility, identified after 5 subjects completed treatment in Part B”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immucothel | Protein / enzyme biologic | 100 ug | Subcutaneous |
| Subject | Montanide | Other / unclassified | — | Subcutaneous |
| Subject | keyhole limpet hemocyanin | Vaccine | 50 mg | Oral |