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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是在启动一项dmid赞助的、irb批准的临床研究之前，评估和标准化样本收集程序和实验室方法，该研究名为“一项II期、随机、盲法研究，研究五价DTaP- hepb - ipv联合疫苗（Pediarix）的安全性和免疫原性，该疫苗用于健康新生儿和出生时2个月和6个月的婴儿，在15个月大时接种DTaP （Infanrix）相对于常规婴儿时间表2,4，6和15个月大（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指定间隔的外周血样本，以评估婴儿对出生时开始的疫苗接种计划的免疫反应，并将其与2个月大时开始的标准免疫计划进行比较。在这项试点研究中，我们将能够仔细评估和确认：1)我们获得脐带血的程序，2)确保免疫细胞活力、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.