High Threshold Peanut Challenge Study

NCT ID: NCT02698033

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-09
• Study Completion Date: 2019-08-22

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.

Conditions

Peanut Allergy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Low dose challenge passed

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

Peanut flour

Intervention Type: 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.

Toasted oat flour

Intervention Type: 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.

Interventions

Peanut flour

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.

Intervention Type: DRUG

Toasted oat flour

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wayne G. Shreffler, MD, PhD

Director, Food Allergy Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne G Shreffler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5U19AI095261-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015P001519

Identifier Type: -

Identifier Source: org_study_id