CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D021183: Peanut Hypersensitivity NIH

(Synonyms: Peanut H, Peanut Hype, Peanut Hypersensitivity)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug1347 Liquid Peanut Extract Wiki 0.71
drug1832 Placebo Glycerin SLIT Wiki 0.71
drug81 ASP0892 Wiki 0.71
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D005512 Food Hypersensitivity NIH 0.71
D006967 Hypersensitivity, NIH 0.41

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0012393 Allergy HPO 0.41

There are 2 clinical trials

Clinical Trials


1 Peanut Sublingual Immunotherapy Induction of Clinical Tolerance of Newly Diagnosed Peanut Allergic 12 to 48 Month Old Children

Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. [Time Frame: Baseline, 36 months] Secondary Objectives: A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance). To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein: 1) peanut specific IgE, IgG, and IgG4 response, 2) peanut specific basophil activation, 3) mast cell responses through skin prick testing, and 4) specific T-cell cytokine responses and T regulatory cell (TReg) activation. The investigators anticipate that the effect of peanut SLIT will occur by induction of TRegs, conversion of T cells from an allergic (TH2) to a non-allergic (TH1) lymphocyte response (measured by cytokines, antibody levels, and skin prick test size), a change in peanut-specific basophil activation, or through a combination of the above. [Time Frame: Baseline, 39 months]

NCT02304991 Peanut Hypersensitivity Food Allergy Food Hypersensitivity Peanut Allergy Drug: Liquid Peanut Extract Drug: Placebo Glycerin SLIT
MeSH:Hypersensitivity Food Hypersensitivity Peanut Hypersensitivity
HPO:Allergy

Primary Outcomes

Description: The primary outcome is to detect a statistically significant difference in reaction thresholds to peanut between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. The difference is measured through utilization of an extreme value hazard function.

Measure: Percentage of participants desensitized to peanut using peanut SLIT as an early intervention in subjects ages 1 to 4 years

Time: From baseline to 36 months

Secondary Outcomes

Description: Detect a statistically significant difference between reaction thresholds to peanut of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance).

Measure: Statistically significant difference in the challenge scores of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance)

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in peanut specific IgE levels

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in peanut specific IgG levels

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in peanut specific IgG4 levels

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in peanut specific basophil activation

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in responses of mast cell as measured by prick skin testing to peanut

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in specific T-cell cytokine responses

Time: From baseline to 39 months

Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.

Measure: The change in T regulatory cell activation

Time: From baseline to 39 months

Description: Incidence of all serious adverse events during the study

Measure: Incidence of all serious adverse events during the study

Time: From baseline to 39 months

2 A Phase 1, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine

The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal (ID) injection in adolescent participants with peanut allergy.

NCT03755713 Peanut Allergy Drug: ASP0892 Drug: Placebo
MeSH:Peanut Hypersensitivity

Primary Outcomes

Description: Adverse Events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). AEs starting or worsening after the first dose of study drug up through study completion will be considered treatment-emergent.

Measure: Safety as assessed by Treatment Emergent Adverse Events (TEAEs)

Time: Up to Day 576

Description: Participants will be asked to record local reactogenicity (pain, tenderness; erythema/redness, Induration/Swelling) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).

Measure: Safety as assessed by local reactogenicity reactions

Time: Up to Day 50

Description: Participants will be asked to record systemic reactogenicity (nausea/vomiting, diarrhea, headache, fatigue, myalgia) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (Potentially Life Threatening).

Measure: Safety as assessed by systemic reactogenicity reactions

Time: Up to Day 50

Description: Number of participants with potentially clinically significant vital sign values.

Measure: Number of participants with vital signs abnormalities and/or adverse events

Time: Up to Day 576

Description: Number of participants with potentially clinically significant laboratory values.

Measure: Number of participants with laboratory value abnormalities and/or adverse events

Time: Up to Day 576

Description: Anti-LAMP-1 antibody formation for all participants will be summarized for each treatment by visit using descriptive statistics.

Measure: Safety assessed by Anti-LAMP-1 antibody

Time: Up to Day 576


HPO Nodes