Impact of Vaccination on Th2 Immunity in Infancy

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Terminated

Conditions

Food Hypersensitivity

Treatments

Procedure: Blood draw

Procedure: Skin prick allergen test

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT02213341

DAIT CoFAR9

Details and patient eligibility

About

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.

Full 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) 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.

Enrollment

77 patients

Sex

All

Ages

5 to 7 months old

Volunteers

Accepts Healthy Volunteers

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:
- 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 criteria

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