Status:
TERMINATED
A Study to Determine the Immunogenicity and Oral Tolerance to Keyhole Limpet Hemocyanin (KLH)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Autoimmune Disorders
Eligibility:
All Genders
18-50 years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
One type of normal immune response is called "oral tolerance." This is when the immune system (the body's natural defense system against illness) turns off (e.g. does not respond) to foods or to other...
Eligibility Criteria
Inclusion
- Healthy
- Ability to give informed consent and comply with study procedures.
- Participant able/willing to hold off receiving prophylactic immunizations (like influenza or pneumococcal vaccines) during the study period.
Exclusion
- Use of corticosteroids within 2 weeks prior to screening visit.
- First degree relative (parent, sibling or child) with history of autoimmune disease.
- Presence of chronic medical illness including but not limited to chronic kidney-, liver-, cardio-vascular diseases, immunodeficiencies, anemia, B12 deficiency, malignancies, or chronic active infections.
- History of acute gastrointestinal illness within 2 weeks prior to oral KLH administration.
- For women of child bearing age, participant unwilling to defer pregnancy, has a positive urine pregnancy test or is currently pregnant or lactating.
- Use of an investigational drug within 3 months of the screening visit.
- History of acute febrile illness within 1 week of screening visit.
- History of allergy to shellfish, previous exposure to KLH/product containing KLH or known-sensitivity to KLH / components of KLH preparation.
- Participants receiving any immunizations within 1 month prior to screening visit.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01489956
Start Date
December 1 2011
End Date
April 1 2013
Last Update
April 12 2016
Active Locations (1)
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1
Mount Sinai Medical Center
New York, New York, United States, 10029