PAID-UP: High Threshold Peanut Challenge Study

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02698033
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 20
• Actual Duration (Months): 44.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peanut Allergy	Drug: Peanut flour; Other: Toasted oat flour

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Dec 9, 2015
• Actual Primary Completion Date: Jul 7, 2016
• Actual Study Completion Date: Aug 22, 2019

Arms and Interventions

Arm

Intervention/Treatment

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

Drug: 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.; Other: 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.

Outcome Measures

Primary Outcome Measures

1. Consistency of High Threshold Reactivity [4 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Wayne G Shreffler, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 18, 2016

More Information

Publications

None provided.

• Responsible Party: Wayne G. Shreffler, MD, PhD, Director, Food Allergy Center, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02698033
• Other Study ID Numbers: 2015P001519; 5U19AI095261-02
• First Posted: Mar 3, 2016
• Last Update Posted: Oct 3, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Wayne G. Shreffler, MD, PhD, Director, Food Allergy Center, Massachusetts General Hospital: food allergy; peanut; food challenge
• Additional relevant MeSH terms: Peanut Hypersensitivity

Study Results

Participant Flow

Arm/Group Title	Peanut Flour
Arm/Group Description	Double Blind Oral food challenge to peanut Peanut flour: A 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.
Period Title: Overall Study
STARTED	7
COMPLETED	6
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Peanut Flour
Arm/Group Description	Double-blind food challenge with peanut flour 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.
Overall Participants	7
Age (Count of Participants)
<=18 years	6 85.7%
Between 18 and 65 years	1 14.3%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	2 28.6%
Male	5 71.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Consistency of High Threshold Reactivity
Description	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
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

1 refused repeat challenge due to other allergic reactivity at time of scheduled procedure

Arm/Group Title	Peanut Flour
Arm/Group Description	Double-blind food challenge with peanut flour 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.
Measure Participants	6
Count of Participants [Participants]	6 85.7%

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	Patient recall of adverse events, with emphasis on accidental ingestion reactions.
Arm/Group Title	Peanut Flour
Arm/Group Description	Double-blind food challenge with peanut flour 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.
All Cause Mortality
	Peanut Flour
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Serious Adverse Events
	Peanut Flour
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Peanut Flour
	Affected / at Risk (%)	# Events
Total	0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.