Impact of Vaccination on Th2 Immunity in Infancy

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.

Study Overview

• Status: Terminated
• Conditions: Food Hypersensitivity
• Intervention / Treatment: Procedure: Blood draw; Procedure: Skin prick allergen test

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.

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infants who are scheduled to receive their ~6 month (third dose of primary series) vaccines including the DTaP vaccine as part of routine care.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive blood test to milk, egg, and/or peanut; Family history to atopy	Procedure: Blood draw; Other Names: venipuncture; Procedure: Skin prick allergen test; To test for hypersensitivity to milk, egg, or peanut
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.	Procedure: Blood draw; Other Names: venipuncture; Procedure: Skin prick allergen test; To test for hypersensitivity to milk, egg, or peanut

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Consortium of Food Allergy Research
• Investigators: Principal Investigator: Hugh A. Sampson, MD, Icahn School of Medicine at Mt. Sinai

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 14, 2016
• Study Completion (Actual): June 14, 2016

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimate): August 11, 2014

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Peanut Allergy; Egg Allergy; Milk Allergy; Infant Vaccination
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: DAIT CoFAR9