High Threshold Peanut Challenge Study

The primary objective of the study is to identify and characterize a sub-population of high-threshold peanut allergic individuals and characterize their immunological phenotype in comparison with the low-threshold peanut allergic individuals enrolled in the adult PN OIT study (NCT01750879).

Clinical Objective:

To evaluate the clinical status of peanut-sensitized individuals previously passing a DBPCFC to 443 mg as being either: non-allergic, stably high-threshold allergic or more clinically reactive on repeat exposure.

Inclusion criteria

• Failure to react to 443 mg of peanut protein during the DBPCFC1 visit of protocol 2012p002153 / AADCRC MGH-004.
• Males and females of all ethnic/racial groups aged 7-55 years old who are otherwise healthy.
• Willingness to sign consent (or for parent/guardian to sign consent).
• Willingness to sign the assent form, if consent provided by parent/guardian.

Exclusion criteria

• History of severe anaphylaxis
• Severe or Moderate asthma
• Poorly controlled asthma
• Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions
• Inability to cooperate with and/or perform oral food challenge procedures
• Primary Immune Deficiency
• Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
• Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
• Use within the past 6 months of other systemic immunomodulatory treatments
• Clinical signs or symptoms of anemia
• Hematocrit <0.36 for adult females or <0.38 for adult males
• Hematocrit <0.34 for children 7-18 years of age
• Weight <23 kg