Immunology Core

免疫学核心

• 批准号: 7727559
• 负责人: Chien-Fu Hung
• 金额: $ 18.41万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7727559
• 关键词: Advisory Committees; Biological Assay; Biometry; CD8B1 gene; Cellular Assay; Cellular Immunity; Clinical Trials; Conflict of Interest; Critiques; Data; Data Analyses; Data Storage and Retrieval; Development; Ensure; Enzyme-Linked Immunosorbent Assay; Flow Cytometry; Funding; Future; Gardasil; Goals; HPV-High Risk; Head; Human Papillomavirus; Human Resources; Human papilloma virus infection; Human papillomavirus 16; Human papillomavirus 6; Immune response; Immunoglobulin G; Immunology; Immunology procedure; In Vitro; Individual; Instruction; Interferon Type II; Label; Laboratories; Lymphocyte; Malignant neoplasm of cervix uteri; Measures; Outcome Measure; Pathology; Peptides; Performance; Peripheral Blood Mononuclear Cell; Phase; Phenotype; Prevention; Procedures; Proteins; Protocols documentation; Quality Control; Reagent; Reproduction spores; Research Personnel; Resources; Sampling; Serum; Services; Specimen; Staining method; Stains; Standardization; Testing; Tissues; Training; Vaccinated; Vaccine Antigen; Vaccines; Virus-like particle; Work; assay development; base; cytokine; data acquisition; data management; database structure; design; enzyme linked immunospot assay; good laboratory practice; immunogenicity; interest; novel; novel vaccines; primary outcome; programs; response

The Immunology Core (Core D) is a new core that was established after discussion by the SPORE Internal and External Advisory Committees and in response to the previous critique of our renewal application. The principal goal of the Core is to establish standardized assays of cellular and humoral immune responses to the vaccines being developed and tested by the four projects of the SPORE program. Standardization will be achieved by use of uniform reagents and protocols, trained personnel and stringent quality control measures. Centralized performance of these assays will facilitate head-to-head comparisons of vaccines that use the same primary immunological outcome measures and provide for efficient use of resources. Because some SPORE investigators have a financial interest in the vaccines that are being tested, assessment of immunogenicity by an independently directed laboratory will also allay concerns over possible conflicts of interest. The services provided by the Core to the individual projects are the following. For Project I, the assays include serum IgG-specific HPV 16 L1 virus like particle (VLP) enzyme linked immunosorbent assay (ELISA) and HPV 16, 31 and 33 in vitro pseudovirion neutralization assays. The latter 2 types are included to assess possible cross neutralization of genetically related types. For Project II, the Core will perform an ELISA to detect serum IgG directed against the vaccinogen, HPV L2 11-200x3 protein and in vitro pseudovirion neutralization assays for HPV 6 and 11 and 15 high risk HPV types. For the subset of subjects vaccinated with Gardasil, serum samples will be tested in the HPV 16 VLP ELISA and HPV 6, 11, 16, 18, 31, 33 and 45 pseudovirion neutralization assays. For Projects III and IV, the Core will perform IFN- gamma ELISPOT assays on unfractionated peripheral blood mononuclear cells (PBMC) following overnight stimulation with pools of E6 or E7 peptides. The CD8+ and CD4 + phenotype of the responding lymphocytes will be confirmed by intracellular cytokine staining and flow cytometry. Secondary immunologic assays, assays specific to an individual project and novel immunologic assay development will be performed and perfected by the investigators within the individual projects and only transferred to the Immunology Core when fully optimized and standardized. The Immunology Core will interact extensively with the individual projects as well as the Tissue/Pathology Core (Core C), which will provide specimens, and the Biostatistlcs/Data Management Core (Core B), which will perform data analyses. RELEVANCE (See Instructions): The Immunology Core will perform standardized assays to assess immune responses to new vaccines for prevention and treatment of human papillomavirus infection.

免疫学核心（核心D）是经过SPORE讨论后建立的新核心 内部和外部咨询委员会，并回应先前对我们续约的批评 应用程序.核心的主要目标是建立细胞和体液免疫的标准化测定方法。 免疫反应的疫苗正在开发和测试的四个项目的孢子计划。 标准化将通过使用统一的试剂和方案、经过培训的人员和严格的 质量控制措施。这些检测试剂盒的集中性能将促进头对头比较 使用相同的主要免疫结果指标并提供有效使用 资源因为一些SPORE调查人员对正在进行的疫苗有经济利益， 由独立指导的实验室进行免疫原性评估也将减轻对 可能的利益冲突。核心为各个项目提供的服务如下。 对于项目I，检测包括血清IgG特异性HPV 16 L1病毒样颗粒（VLP）酶联免疫吸附试验（ELISA）。 免疫吸附测定（ELISA）和HPV 16、31和33体外假病毒体中和测定。后者 包括2种类型，以评估遗传相关类型的可能交叉中和。对于项目II， 中心将进行ELISA检测针对疫苗原HPV L2 11- 200 x3蛋白的血清IgG 以及用于HPV 6和11以及15高风险HPV类型的体外假病毒体中和测定。为子集 在接种Gardasil的受试者中，将在HPV 16 VLP ELISA和HPV 6，11， 16、18、31、33和45假病毒体中和测定。对于项目III和IV，核心将执行IFN- 过夜后对未分级外周血单核细胞（PBMC）的γ ELISPOT测定 用E6或E7肽库刺激。应答淋巴细胞的CD 8+和CD 4+表型 将通过细胞内细胞因子染色和流式细胞术确认。二级免疫测定， 将进行特定于单个项目的试验和新型免疫试验开发， 由研究者在各个项目中完善，仅转移到免疫学核心 完全优化和标准化。免疫学核心将与个人广泛互动 项目以及将提供标本的组织/病理学核心（核心C），以及 生物统计员/数据管理核心（核心B），将进行数据分析。 相关性（见说明）： 免疫学核心将进行标准化检测，以评估对新疫苗的免疫反应， 预防和治疗人乳头瘤病毒感染。