Status:
TERMINATED
Impact of Vaccination on Th2 Immunity in Infancy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Consortium of Food Allergy Research
Conditions:
Food Hypersensitivity
Eligibility:
All Genders
5-7 years
Brief Summary
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...
Detailed Description
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) v...
Eligibility Criteria
Inclusion
- 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:
- A negative skin prick test to egg, milk, and peanut
- A negative IgE to egg, milk, and peanut
- Group 2 participants must have all of the following:
- A positive family history of allergic disease
- Atopic Dermatitis not requiring prescription medication
- A positive IgE to milk, egg, and/or peanut
- If Group 1 enrollment is completed first, participants must have all of the following to be enrolled in Group 2:
- A family history of atopy
- Atopic dermatitis not requiring prescription medication
- 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
- History of anemia requiring any treatment
- Previous allergic reaction to any food, defined as itching, rash, hives, swelling, vomiting, diarrhea, sneezing, rhinorrhea, wheezing, breathing difficulty, or passing out immediately after food ingestion.
- Evidence of non-IgE-mediated reaction to milk or soy (i.e. milk/soy protein intolerance) or evidence of food protein induced enterocolitis syndrome (FPIES)
- Severe atopic dermatitis (liberally defined as requiring prescription medication)
- Unable to obtain serum sample for determination of egg, milk and peanut IgE levels
- Use of short-acting anti-histamines (diphenhydramine, etc.) more than one time within 3 days of skin testing or on the day of skin testing
- Any history of intravenous or oral steroid medication
- Known underlying immune defect/deficiency or bleeding disorder
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 14 2016
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT02213341
Start Date
January 1 2015
End Date
June 14 2016
Last Update
July 23 2019
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029