A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew, or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT).
A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT). Enrolled participants must be positive at or before the 300 mg (443 mg cumulative) dosing level of FA protein. OIT treatment groups will be cashew or shrimp. All cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC. Participants that pass their food challenge with no or mild objective reactions to up to a cumulative 2043 mg of the FA allergen in their OIT at the end of this phase (primary outcome) will be considered desensitized and have successfully met the primary endpoint. All participants then will continue in the study by undergoing withdrawal from OIT for 6 weeks to examine mechanisms underlying sustained responsiveness (SU) which will be defined as a participant's passing a DBPCFC with no or mild objective reaction to up to a cumulative 2043 mg of the FA allergen in their DBPCFC at week 58. Those participants who pass the Week 58 challenge up to a cumulative of 2043 mg will be given the option to continue the withdrawal phase up to Week 64 which will be end of study. Week 58 will be end of study for those who do not opt for this continuation of withdrawal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
All cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC.
Sean N Parker Center For Allergy and Asthma Research
Palo Alto, California, United States
Expression of CD28 in the CD4+ Allergen Specific (CD154+)
Expression of CD28 in the CD4+ allergen specific (CD154+) T-cells at baseline and 52 weeks, reported as the percentage of allergen specific (reactive) cells.
Time frame: baseline and 52 week
Expression of CD28+ Allergen Specific (CD154+) T-cells
Expression of CD28+ allergen specific (CD154+) T-cells at baseline, week 52, and week 58, reported as the percentage of allergen specific (reactive) cells.
Time frame: baseline, week 52 and week 58
Expression of the Mechanistic Markers Vis Luminex Assay
Expression of the following measures in CD4+CD28+ allergen specific (CD154+) T-cells at baseline, week 52, and week 58. Data were collected for IFN-gamma, IL-4 and IL-10 via Luminex assay. Data collection was planned for receptor diversity in allergen specific T cell CDR3b as compared to non-specific T cells, and TGF beta, but these data were not collected. The median value (with full range) of mean fluorescence intensity across participants is reported for each time point.
Time frame: baseline, week 52, and week 58
Expression of the Mechanistic Marker Via Flow Cytometry
Expression of the following measures in CD4+CD28+ allergen specific (CD154+) T-cells at baseline, week 52, and week 58. Data were collected for GPR15 via flow cytometry resulting in mean fluorescence intensity. Data collection was planned for receptor diversity in allergen specific T cell CDR3b as compared to non-specific T cells, and TGF beta, but these data were not collected. The median value (with full range) of mean fluorescence intensity across participants is reported for each time point.
Time frame: baseline, week 52, and week 58
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