Reduction of Peanut Reactivity and Immune Modulation With Anti-IgE Therapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Allergy, Allergy, Neurology |
| Therapuetic Areas: | Neurology, Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/19/2019 |
| Start Date: | January 2015 |
| End Date: | December 2020 |
Pilot Study to Collect Blood From Research Subjects Allergic and Non-allergic to Peanut to Study Immune Modulation With Anti-IgE Therapy in Mice
This pilot study is will examine the pathways involved in allergic response, primarily in
food allergy; specifically peanut allergy. We will also study non-allergic donors as well as
patients with atopic disorders, primarily as control subjects. We believe that this study
will lead to discovery of significant pathways involved in the allergic pathway that can be
explored in more detail during follow-up studies in order to address mechanistic questions
that cannot be answered in a pilot trial. We believe that such a pilot study represents the
ideal approach to identify effective therapeutic interventions and to simultaneously better
understand the underlying mechanistic properties involved in the allergy cascade. We think
that this study forms the basis for a novel avenue of research into the pathogenesis of
allergic pathways, a disease that is still associated with significant morbidity and
mortality.
food allergy; specifically peanut allergy. We will also study non-allergic donors as well as
patients with atopic disorders, primarily as control subjects. We believe that this study
will lead to discovery of significant pathways involved in the allergic pathway that can be
explored in more detail during follow-up studies in order to address mechanistic questions
that cannot be answered in a pilot trial. We believe that such a pilot study represents the
ideal approach to identify effective therapeutic interventions and to simultaneously better
understand the underlying mechanistic properties involved in the allergy cascade. We think
that this study forms the basis for a novel avenue of research into the pathogenesis of
allergic pathways, a disease that is still associated with significant morbidity and
mortality.
The study aims to characterize the pathways involved in the allergic response, primarily in
food allergy; specifically peanut allergy. We will also study non-allergic donors as well as
patients with atopic disorders, primarily as control subjects. All eligible study
participants will have documented elevated total IgE levels, peanut positivity or another
antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens) prior to being
enrolled in the study. Our study will focus on allergic as well as non-allergic individuals.
We plan on collecting samples from a total of 60 patients during one time point (peanut
allergic individuals, non-atopic/allergic individuals, atopic individuals-other than peanut
allergy). We believe that such a pilot study represents the ideal approach to identify
effective therapeutic interventions and to simultaneously better understand the underlying
mechanistic properties involved in the allergy cascade. We plan to obtain a detailed history
prior to enrollment as well as objective data (ie SPT as well as Immunocap testing results).
There will be 3 study groups and studies will be performed on approximately 20 peanut
allergic patients, 20 non-allergic controls, and 20 allergic/atopic (non-peanut allergic, but
allergic to indoor/outdoor allergen) individuals. There will be one blood draw required at
each visit (weeks 0, 4, 8). Each blood draw will require 105 ml of whole blood to be
collected in ten heparinized 10-mL tubes and one EDTA tube. We plan to assess the levels of
total IgE and IgG as well as antigen specific IgG and IgE in the peripheral blood of
patients. We will specifically perform ELISA testing that detects these levels. We will also
perform in vitro CD4+ T cell proliferation assays. For this purpose, patients' peripheral T
cells will be isolated with a combination of magnetic beads and flow cytometric sorting.
food allergy; specifically peanut allergy. We will also study non-allergic donors as well as
patients with atopic disorders, primarily as control subjects. All eligible study
participants will have documented elevated total IgE levels, peanut positivity or another
antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens) prior to being
enrolled in the study. Our study will focus on allergic as well as non-allergic individuals.
We plan on collecting samples from a total of 60 patients during one time point (peanut
allergic individuals, non-atopic/allergic individuals, atopic individuals-other than peanut
allergy). We believe that such a pilot study represents the ideal approach to identify
effective therapeutic interventions and to simultaneously better understand the underlying
mechanistic properties involved in the allergy cascade. We plan to obtain a detailed history
prior to enrollment as well as objective data (ie SPT as well as Immunocap testing results).
There will be 3 study groups and studies will be performed on approximately 20 peanut
allergic patients, 20 non-allergic controls, and 20 allergic/atopic (non-peanut allergic, but
allergic to indoor/outdoor allergen) individuals. There will be one blood draw required at
each visit (weeks 0, 4, 8). Each blood draw will require 105 ml of whole blood to be
collected in ten heparinized 10-mL tubes and one EDTA tube. We plan to assess the levels of
total IgE and IgG as well as antigen specific IgG and IgE in the peripheral blood of
patients. We will specifically perform ELISA testing that detects these levels. We will also
perform in vitro CD4+ T cell proliferation assays. For this purpose, patients' peripheral T
cells will be isolated with a combination of magnetic beads and flow cytometric sorting.
Inclusion Criteria for Groups 1-3:
Group 1: Peanut allergic individuals (n=20)
- 18-65 years of age
- Positive ImmunoCAP test (Optional)
- Documented elevated total IgE levels, peanut positivity or another antigen/allergen
specific elevated IgE (ie common indoor/outdoor allergens)
- Experienced at least one of the following symptoms within 60 minutes of exposure:
- Skin-related symptom (i.e., hives and edema)
- Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive
coughing, and dyspnea)
- Gastrointestinal-related symptom (i.e., vomiting and diarrhea)
Group 2: Allergic/atopic individuals (not allergic to peanut; n=20)
- 18-65 years of age.
- Positive ImmunoCAP test (Optional)
- Documented elevated total IgE levels or an indoor/outdoor antigen/allergen (other than
peanut) specific elevated IgE (ie common indoor/outdoor allergens).
- Experienced at least one of the following symptoms within 60 minutes of exposure:
- Skin-related symptom (i.e., hives and edema).
- Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive
coughing, and dyspnea).
- Gastrointestinal-related symptom (i.e., vomiting and diarrhea)
Group 3: Non-allergic individuals (healthy controls; n=20)
- 18-65 years of age.
- Negative ImmunoCAP test (Optional)
- Documented absence or low total IgE levels, or negativity for an antigen/allergen
specific elevated IgE (ie common indoor/outdoor allergens).
- Has not experienced at least one of the following symptoms within 60 minutes of
exposure to a particular substance:
- Skin-related symptom (i.e., hives and edema).
- Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive
coughing, and dyspnea).
- Gastrointestinal-related symptom (i.e., vomiting and diarrhea)
Exclusion Criteria for Groups 1-3:
- Prior therapy with anti-IgE
- Steroid use greater than 10 mg/d prednisone or equivalent 30 days prior to enrollment
- Any immunosuppressive drug use within 3 months prior to screening (mycophenolate
mofetil, hydroxychloroquine, azathioprine, methotrexate, leflunomide, rituximab,
cyclophosphamide, intravenous immunoglobulin, plasmapheresis)
- Ongoing chronic infection (viral, bacterial or fungal) including known HIV, Hepatitis
B/C
- Acute infection receiving any antibiotics within 30 days prior to screening
- Probiotics (greater than estimated 109 cfu or organisms per day) within 30 days prior
to enrollment (with the exception of fermented beverages, milks or yogurts).
- Malignancy within one year prior to screening (with the exception of non-metastatic
squamous or basal cell skin carcinomas and cervical carcinoma if received curative
surgical treatment)
- Known illicit drug or alcohol abuse
- Pregnancy
We found this trial at
1
site
New York, New York 10021
Principal Investigator: Odelya Pagovich, MD
Phone: 646-962-2672
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