Impact of Vaccination on Th2 Immunity in Infancy

NCT02213341 | Terminated

• 1 other identifier: DAIT CoFAR9
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Hypersensitivity

Keywords

Milk Allergy; Egg Allergy; Peanut Allergy; Infant Vaccination

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Family history to atopy

Procedure: Skin prick allergen test; Procedure: Blood draw

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: Skin prick allergen test; Procedure: Blood draw

Interventions

Skin prick allergen test PROCEDURE

To test for hypersensitivity to milk, egg, or peanut

Negative blood test to allergy; Positive blood test to milk, egg, and/or peanut

Blood draw PROCEDURE

Also known as: venipuncture

Negative blood test to allergy; Positive blood test to milk, egg, and/or peanut

Eligibility Criteria

• Age: 5 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

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

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Consortium of Food Allergy Research: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Food Hypersensitivity; Milk Hypersensitivity; Egg Hypersensitivity; Peanut Hypersensitivity

Interventions

Blood Specimen Collection; Phlebotomy

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Therapeutics

Study Officials

• Hugh A. Sampson, MD

  Icahn School of Medicine at Mt. Sinai

  PRINCIPAL INVESTIGATOR

• Scott Sicherer, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: January 1, 2015
• Primary Completion: June 14, 2016
• Study Completion: June 14, 2016
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (1)