Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.


Clinical Trial Description

To effectively address the Primary Objectives of this pilot study, 30 subjects aged 6-21 years with: (1) a convincing clinical history of PA, (2) a serum IgE specific to peanut of >0.35 kUa/L and a skin prick test (SPT) wheal >3 mm, will be enrolled. Subjects will be recruited from the Johns Hopkins Pediatric Allergy Clinic.

Participants will undergo an initial screening visit that will include a medical history, physical exam, skin testing, and phlebotomy. Informed consent and assent will be obtained. At the next two visits, 20 participants will complete a double-blind placebo-controlled food challenge (DBPCFC). Eligible subjects will be randomized in a 1:1 ratio into two groups. One group will receive active SLIT with placebo OIT and the other group will begin active OIT with placebo SLIT dose escalation. Over the next 16 weeks of the study, subjects will undergo SLIT and OIT dose increases. A maintenance dose will then be taken at home daily for 12 months. A DBPCFC will be completed after 6 months and 12 months of home dosing. Those patients who pass the DBPCFC will be taken off SLIT and OIT for 4 weeks. A final challenge will be administered at the end of this period.

Ten additional peanut-allergic subjects age 6-21 years will be enrolled and followed as longitudinal controls for the mechanistic studies. These subjects will follow a modified schedule compared to those subjects receiving study treatment and will be evaluated by phlebotomy, end point titration prick skin testing, and saliva collection. These patients will continue strict avoidance of peanut unless otherwise advised by their personal physician. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01084174
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2010
Completion date January 2013

See also
  Status Clinical Trial Phase
Completed NCT01904604 - Peanut Epicutaneous Phase II Immunotherapy Clinical Trial Phase 2
Enrolling by invitation NCT04885959 - The Effects of Traditional Asian Diet on Gut Microbiome and Metabolome in Healthy Volunteers and Pregnancy on Subsequent Infant's Allergy Development N/A
Recruiting NCT03974555 - Epidemiological Investigation and Cohort Study on Food Allergy in Children Aged 3 to 6 Years in Wenzhou and Taizhou Urban Areas
Recruiting NCT05177744 - Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease
Completed NCT01420705 - Bacille Calmette-Guérin (BCG) Vaccine and Atopy N/A
Completed NCT00850668 - Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults Phase 1
Withdrawn NCT00736112 - Food Allergy - Tubes - Adenoids (FATA) Trial N/A
Active, not recruiting NCT00298337 - Use of Probiotic Bacteria in Prevention of Allergic Disease in Children 1999-2008 Phase 2/Phase 3
Completed NCT03693456 - Food Allergy Diagnostic Test Response to Previous Oral Challenge Response N/A
Completed NCT00461097 - Oral Immunotherapy for Childhood Egg Allergy Phase 2
Completed NCT02606721 - Food Allergy Challenge Diagnostic Study
Active, not recruiting NCT02457416 - Take Away Food Allergy; Inducing Tolerance in Children Allergic to Peanut N/A
Completed NCT02825069 - Study on the Induction of Food Tolerance in Babies N/A
Completed NCT02350660 - Oral Immunotherapy for Peanut and Mammalian Meat Allergies N/A
Completed NCT00597675 - Oral Immunotherapy for Peanut Allergy (PMIT) Phase 2
Completed NCT00932828 - Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study Phase 2
Completed NCT01373242 - Sublingual Immunotherapy for Peanut Allergy and Induction of Tolerance Phase 1/Phase 2
Completed NCT00578656 - An Interventional Study of Milk Allergy Phase 0
Completed NCT00356174 - An Observational Study of Childhood Food Allergy N/A
Completed NCT03639337 - Colonization and Persistence Capacity of a Multi-strain Probiotics in Pediatric Food Allergy to Milk or Egg. N/A