Clinical Trial: Impact of Vaccination on Th2 Immunity in Infancy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Impact of Vaccination on Th2 Immunity in Infancy

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 Summary: 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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: August 7, 2014
Date Started: August 2014
Date Completion:
Last Updated: November 7, 2016
Last Verified: November 2016