A Study to Determine the Immunogenicity and Oral Tolerance to Keyhole Limpet Hemocyanin (KLH)
Stopped early · Early Phase 1
Conditions studied: Autoimmune Disorders
In brief
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.
Key facts
- Study ID
- NCT01489956
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 19
- Starts
- 2011-12-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2016-04-12
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Mount Sinai Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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