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| Name | Class |
|---|---|
| University of South Florida | OTHER |
| Children's Hospital Los Angeles | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfed | 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 |
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| Bottlefed | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample/ stool sample | Procedure | blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine response | post immunization antibody titers (via ELISA) to Hib, tetanus, diphtheria, pertussis and pneumococcal polysaccharide serotypes contained in the Prevnar 13 vaccine. | 12 months |
| Antibody activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Sleasman, MD | Duke University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| UNC Chapel Hill |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Four 2.6 ml ACD tubes will be collected . All blood will be processed for pyrosequencing, TBNK, CBC and differential, platelets, sera plasman and PBMC's. Stool samples
Functional activity of antibodies measured by opsonophagocytic activity to Pneumococcal and Hib vaccine
| 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. | 12 months |
| Chapel Hill |
| North Carolina |
| 27514 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |