This study will follow 40 healthy, vaginally delivered infants that are primarily (\>/- 75%) breast fed and 40 infants that are exclusively formula fed for at least the first 4 months of life from birth until 12 month age. Visits - Subjects will be consented prior to delivery, visit 1. Subject will be seen if possible after delivery for instruction on stool collection and distribution of supplies, visit 2. Subject will be seen at 6 months of age post immunization, visit 3. Subject will be seen prior to 12 month visit. Study staff will contact via phone/email to collect information about feeding changes.
Cord Blood will be collected at birth if possible and peripheral blood will be collected at 6 month of age (5 to 10 days after receiving their standard 6 month immunizations) and at 12 months of age prior to their 12 month immunization. Additionally, stool samples will be collected within the first week of live and once monthly through 12 months of age. Breastfeeding mothers will collect breast milk once monthly at the same time as the stool specimen during the period of breastfeeding.
Study Type
OBSERVATIONAL
Enrollment
85
blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home.
Children's Hospital Los Angeles
Los Angeles, California, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Molecular profile of human IgG and IgA by pyrosequencing.
B cell priming and immunoglobulin diversity following immunizations at 2 and 4 month of age by modulating the microbial colonization of infant gut by pyrosequencing by using isotype specific primers.
Time frame: 12 months
Vaccine response
post immunization antibody titers (via ELISA) to Hib, tetanus, diphtheria, pertussis and pneumococcal polysaccharide serotypes contained in the Prevnar 13 vaccine.
Time frame: 12 months
Antibody activity
Functional activity of antibodies measured by opsonophagocytic activity to Pneumococcal and Hib vaccine
Time frame: 12 months
Plasma level of B cell activating factor and/or a proliferation-inducing ligand
Degree of B cell differentiation and activation in B cell by BD bioscience Canto flow cytometry.
Time frame: 12 months
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