Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults
The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This is a research study to test stimulation of the immune system to improve peanut allergy. The approach the investigators will use for peanut allergy is called desensitization. A person becomes desensitized to a food by taking small, increasing amounts of the food to help the body become used to the food so that it no longer causes a severe allergic reaction.
The study also looks at the safety and immune system effects of the investigational study product, peanut protein. The word "investigational" means the study product is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
This project is designed to study if peanut oral immunotherapy (POIT) will desensitize subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity and cause long-term tolerance.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults|
- To treat peanut-allergic subjects with POIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes long-term tolerance. [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- To determine the effect that POIT has on the peanut-specific cellular and humoral response in peanut-allergic subjects. [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
|Experimental: Peanut protein||
Drug: powdered peanut protein
Active peanut allergy will be confirmed in all subjects with Double Blind Placebo Controlled Food Challenge (DBPCFC) 2 gm peanut protein oral food challenge prior to entry into the study. Oral desensitization begins with the modified rush. The first dose is 0.1 mg of peanut protein, the dose is doubled every 30 minutes until a maximum of 6 mg of peanut protein. The daily dose will be given at home until the scheduled escalation visit. Subjects return for escalation visits in the Food Allergy Study Center (FACS) every two weeks. The maintenance phase begins once the subject reaches 2300mg. This dose is taken daily. The maintenance phase begins once the subject reaches 2300mg which they take daily at home. All subjects will have a Double-Blind Placebo-Controlled Food Challenge (DBPCFC) at the end of 18 months of POIT to assess for desensitization.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274429
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Wesley Burks, MD||Duke University|