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High Threshold Peanut Challenge Study (PAID-UP)

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ClinicalTrials.gov Identifier: NCT02698033
Recruitment Status : Completed
First Posted : March 3, 2016
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital

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
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.

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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 : December 9, 2015
Actual Primary Completion Date : July 7, 2016
Actual Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort 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.




Primary Outcome Measures :
  1. Consistency of High Threshold Reactivity [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
PBMC


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698033


Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Wayne G Shreffler, MD, PhD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital:
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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 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2016    Key Record Dates
Results First Posted: October 3, 2019
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital:
food allergy
peanut
food challenge
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate