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Lack of enrollment.
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| Name | Class |
|---|---|
| Consortium of Food Allergy Research | OTHER |
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The purpose of this study is to assess the responses in the immune system of infants after they receive the vaccine against diphtheria, tetanus, and pertussis (DTaP). The investigators will do this by studying the immune cells and allergy responses in the blood prior to and after receipt of the third DTaP vaccine.
This is a single-site study of infants who are scheduled to receive their third series (~6 month) vaccinations, as routine care, to investigate whether the diphtheria, tetanus, and pertussis (DTaP) vaccination has an effect on specific immunoglobulin E (IgE) levels to milk, egg, or peanut. Infants will be assigned to one of two groups depending on the infant's sensitization to milk, egg, and peanut.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive blood test to milk, egg, and/or peanut | Family history to atopy |
| |
| Negative blood test to allergy | A negative skin prick test to egg, milk, and peanut and a negative Immunoglobulin E (IgE) to egg, milk, and peanut. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin prick allergen test | Procedure | To test for hypersensitivity to milk, egg, or peanut |
|
| Measure | Description | Time Frame |
|---|---|---|
| Allergen-specific IgE | Magnitude of increase of allergen-specific IgE. For each child, the maximum allergen-specific IgE change to milk, egg, or peanut will be considered as the primary endpoint. | baseline and day 28 |
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Inclusion Criteria:
Written informed consent from parent/guardian
General good health without other known need for blood draws that would conflict with the study volume requirements
Aged 5 months - 7 months, any race/ethnicity, any gender
Subjects must not have yet received their third DTaP vaccination, which typically is given at 6 months of age. Subjects must have previously received two doses of the DTaP vaccination, at ages 2 months and 4 months
Willingness to return for follow-up testing as defined in the protocol and consent if screening tests indicate eligibility
Group 1 participants must have all of the following:
Group 2 participants must have all of the following:
If Group 1 enrollment is completed first, participants must have all of the following to be enrolled in Group 2:
If Group 2 enrollment is completed first, participants must have all of the following to be enrolled in Group 1:
-No personal or family history of atopic disease
Exclusion Criteria:
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Infants who are scheduled to receive their ~6 month (third dose of primary series) vaccines including the DTaP vaccine as part of routine care.
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| Name | Affiliation | Role |
|---|---|---|
| Hugh A. Sampson, MD | Icahn School of Medicine at Mt. Sinai | Principal Investigator |
| Scott Sicherer, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| Consortium of Food Allergy Research (CoFAR) |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D016269 | Milk Hypersensitivity |
| D021181 | Egg Hypersensitivity |
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000074924 | Nut and Peanut Hypersensitivity |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Whole blood
| Blood draw | Procedure |
|
|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |