Infant Immunity Response and Immunoglobulin Diversity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREblood sample/ stool sample
blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home.
Sponsors
University of South Florida
Children's Hospital Los Angeles
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Self-declared pregnant woman * Age 18 years or older at the time of consent * Willing and able to sign consent and follow study schedule * Planned vaginal delivery * Willing to primarily breastfed or formula feed for the first four months
Exclusion criteria
* Planned delivery by C-Section * Unwillingness to exclusively breast feed or formula feed their infant for at least the first 4 months * Unwillingness to receive standard immunizations on the schedule recommended by the American Academy of Pediatrics * Chronic maternal condition that may influence infant immunity including but not limited to: maternal HIV, immunodeficiency, use of immunosuppressive medications, malignancy or autoimmunity * Known fetal medical conditions such as congenital malformations * Use of immune modulating/immune suppressive medication and prophylactic antibiotics during pregnancy * Any condition that may prevent a mother who plans to breast feed from breast feeding * Any condition that in the opinion of the investigator would interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Molecular profile of human IgG and IgA by pyrosequencing. | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine response | 12 months | post immunization antibody titers (via ELISA) to Hib, tetanus, diphtheria, pertussis and pneumococcal polysaccharide serotypes contained in the Prevnar 13 vaccine. |
| Antibody activity | 12 months | Functional activity of antibodies measured by opsonophagocytic activity to Pneumococcal and Hib vaccine |
| Plasma level of B cell activating factor and/or a proliferation-inducing ligand | 12 months | Degree of B cell differentiation and activation in B cell by BD bioscience Canto flow cytometry. |
Countries
United States
Outcome results
None listed