High Threshold Peanut Challenge Study

NCT02698033 | Completed Results DMC

• 2 other identifiers: 2015P0015195U19AI095261-02
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peanut Allergy

Keywords

food allergy; peanut; food challenge

Outcome Measures

Primary Outcomes (1)

• Consistency of High Threshold Reactivity

  The proportion of high-threshold peanut allergic individuals among participants who previously failed to react to a 443 mg peanut protein challenge in NCT01750879 who also reacted \>443 cumulative total dose on repeat challenge

  4 weeks

Study Arms (1)

Low dose challenge passed

Individuals who tolerated without dose limiting symptoms the screening food challenge for a parent interventional trial

Drug: Peanut flour; Other: Toasted oat flour

Interventions

Peanut flour DRUG

A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.

Low dose challenge passed

Toasted oat flour OTHER

A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.

Low dose challenge passed

Eligibility Criteria

• Age: 7 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

PBMC

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Wayne Shreffler
• Organization: Massachusetts General Hospital

wshreffler@mgh.harvard.edu

6177266147

Study Officials

• Wayne G Shreffler, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Food Allergy Center

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: March 3, 2016
• Study Start: December 9, 2015
• Primary Completion: July 7, 2016
• Study Completion: August 22, 2019
• Last Updated: October 3, 2019
• Results First Posted: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share