PILOT STUDY TO OPTIMIZE AND STANDARDIZE UMBILICAL CORD BLOOD COLLECTION AND T

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to evaluate and standardize specimen collection procedures and laboratory methods prior to initiation of a DMID-sponsored, IRB-approved clinical study entitled "A Phase II, Randomized, Blinded Study of the Safety and Immunogenicity of Pentavalent DTaP-HepB-IPV Combination Vaccine (Pediarix) Administered to Healthy Neonates and Infants at Birth, 2 and 6 Months of Age with DTaP (Infanrix) Administered at 15 Months of Age Relative to a Routine Infant Schedule at 2, 4, 6 and 15 Months of Age (IRB# 10410-01[100]; PI Joel Ward; NIH/DMID# 03-062)." In the clinical study, we will be collecting cord blood samples at birth and peripheral blood samples at specified intervals to assess the infant's immune response to a vaccine schedule starting at birth compared with the standard immunization schedule starting at 2 months of age. In this pilot study, we will be able to carefully assess and confirm: 1) our procedures for obtaining umbilical cord blood, 2) the methods for ensuring immune cell viability, freezing and shipping, 3) the conditions for optimization of immune cell isolation procedures, and 4) the range of antigen concentrations required for immune cell stimulation. Information gathered during the pilot study will be used for formalizing the procedures we will use in the larger clinical study.