Impact of Vaccination on Th2 Immunity in Infancy

Food Hypersensitivity Clinical Trial

Official title:

Impact of Vaccination on Th2 Immunity in Infancy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02213341
• Other study ID #: DAIT CoFAR9
• Status: Terminated
• Start date: January 2015
• Est. completion date: June 14, 2016

Study information

• Verified date: July 2019
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 studying the immune cells and allergy responses in the blood prior to and after receipt of the third DTaP vaccine.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: June 14, 2016
• Est. primary completion date: June 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 7 Months

Eligibility

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

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity

Intervention

Procedure:
• Skin prick allergen test
To test for hypersensitivity to milk, egg, or peanut
• Blood draw

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Consortium of Food Allergy Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Consortium of Food Allergy Research (CoFAR)
•   Division of Allergy, Immunology, and Transplantation (DAIT)
•   National Institute of Allergy and Infectious Diseases (NIAID)