An observational study in Infant Immunity Response and Immunoglobulin Diversity, sponsored by Duke University. Completed at 3 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-29.
Sponsored by Duke University · Observational
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.
Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
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Exclusion Criteria:
collection of blood/stool/breast milk samples and information about feeding changes and introduction of solid foods. - Cord Blood sample, stool samples monthly and blood sample at 6 month and 12 months of age
Procedure: blood sample/ stool sample
collection of blood/stool samples and information about feeding changes and introduction of solid foods. Coord blood sample, stool samples monthly and blood sample at 6 month and 12 month of age.
Procedure: blood sample/ stool sample
blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home.
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
Ran from Jan 2015 to primary completion in Nov 2017, 34 months.
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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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