Impact of Vaccination on Th2 Immunity in Infancy

Stopped early

Conditions studied: Food Hypersensitivity

In brief

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.

Key facts

Study ID

NCT02213341

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

77

Starts

2015-01-01

Expected to finish

2016-06-14

Last updated by the study team

2019-07-23

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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