Clinical trial NCT02698033: High Threshold Peanut Challenge Study
Official title: Follow-Up Protocol For Peanut Allergic Individuals With Documented Objective Clinical Unresponsiveness to a Double-Blind Placebo-Controlled Food Challenge With Peanut Protein
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peanut Allergy
Keywords: food allergy
peanut
food challenge
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses.

Brief summary: This protocol is designed to better characterize a sub-population of peanut sensitized individuals who may be non-allergic, despite significant sensitization, or who may be allergic, but at high threshold doses. By specifically targeting participants who met the initial screening criteria of the active adult PN OIT study, Protocol 2012p002153 / AADCRC MGH-004 (MGH-004), but failed to react during the pre-treatment 443 mg challenge to peanut, the investigators anticipate that the investigators will identify individuals who have become spontaneously tolerant, despite persistent sensitization. The investigators might also find that clinical sensitivity persists but only with higher thresholds, or that sensitivity has increased (or is variable) since the previous allergen exposure. By repeating DBPCFCs through to a full serving dose (7.4 gram), the investigators will distinguish participants who react only at higher doses from those who were not truly peanut allergic, address whether their sensitivity has changed, and have the opportunity to further investigate their immune response to peanut allergen.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Consistency of High Threshold Reactivity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Wayne G Shreffler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: