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Trial record 7 of 7 for:    "Cow Milk Allergy" | "Immunoglobulins"

Impact of Vaccination on Th2 Immunity in Infancy

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ClinicalTrials.gov Identifier: NCT02213341
Recruitment Status : Terminated (Lack of enrollment.)
First Posted : August 11, 2014
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Consortium of Food Allergy Research
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment
Food Hypersensitivity Procedure: Skin prick allergen test Procedure: Blood draw

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.

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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Vaccination on Th2 Immunity in Infancy
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 14, 2016
Actual Study Completion Date : June 14, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Positive blood test to milk, egg, and/or peanut
Family history to atopy
Procedure: Skin prick allergen test
To test for hypersensitivity to milk, egg, or peanut

Procedure: Blood draw
Other Name: venipuncture

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
To test for hypersensitivity to milk, egg, or peanut

Procedure: Blood draw
Other Name: venipuncture




Primary Outcome Measures :
  1. Allergen-specific IgE [ Time Frame: baseline and day 28 ]
    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.


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213341


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Consortium of Food Allergy Research
Investigators
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Principal Investigator: Hugh A. Sampson, MD Icahn School of Medicine at Mt. Sinai
Principal Investigator: Scott Sicherer, MD Icahn School of Medicine at Mount Sinai

Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02213341     History of Changes
Other Study ID Numbers: DAIT CoFAR9
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Milk Allergy
Egg Allergy
Peanut Allergy
Infant Vaccination
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Vaccines
Immunologic Factors
Physiological Effects of Drugs