Impact of Vaccination on Th2 Immunity in Infancy

NCT ID: NCT02213341

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-06-14

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

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) 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.

Conditions

Food Hypersensitivity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Positive blood test to milk, egg, and/or peanut

Family history to atopy

Skin prick allergen test

Intervention Type: PROCEDURE

To test for hypersensitivity to milk, egg, or peanut

Blood draw

Intervention Type: PROCEDURE

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.

Skin prick allergen test

Intervention Type: PROCEDURE

To test for hypersensitivity to milk, egg, or peanut

Blood draw

Intervention Type: PROCEDURE

Interventions

Skin prick allergen test

To test for hypersensitivity to milk, egg, or peanut

Intervention Type: PROCEDURE

Blood draw

Intervention Type: PROCEDURE

Other Intervention Names

venipuncture

Eligibility Criteria

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

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 7 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Consortium of Food Allergy Research

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugh A. Sampson, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mt. Sinai

Scott Sicherer, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Related Links

https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT)

http://www.cofargroup.org/

Consortium of Food Allergy Research (CoFAR)

Other Identifiers

DAIT CoFAR9

Identifier Type: -

Identifier Source: org_study_id