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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的目的是在DMID赞助的、IRB批准的临床研究开始之前，评估和标准化样本采集程序和实验室方法，该研究题为“A阶段，随机、盲目研究五价DTaP-HepB-IPV联合疫苗(Pediarix)对出生时、2个月和6个月大的健康新生儿和婴儿的安全性和免疫原性，相对于2、4、6和15个月的常规婴儿时间表(IRB#10410-01[100]；PI Joel Ward；NIH/DMID#03-062)。”在临床研究中，我们将收集出生时的脐带血样本和特定时间间隔的外周血样本，以评估婴儿对出生时开始接种疫苗计划的免疫反应，并与从2个月大开始的标准免疫计划进行比较。在这项初步研究中，我们将能够仔细评估和确认：1)我们获取脐带血的程序；2)确保免疫细胞存活、冷冻和运输的方法；3)优化免疫细胞分离程序的条件；以及4)免疫细胞刺激所需的抗原浓度范围。在试点研究期间收集的信息将用于正式确定我们将在更大的临床研究中使用的程序。

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.