A PHASE I STUDY OF INACTIVATED VERO CELL-CULTURE INFLUENZA A/H5N1 GIVEN ALONE

单独给予灭活 VERO 细胞培养 A/H5N1 流感的 I 期研究

• 批准号: 7608174
• 负责人: JAMES D CAMPBELL
• 金额: $ 8.98万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608174
• 关键词: Adjuvant; Adult; Aluminum Hydroxide; Computer Retrieval of Information on Scientific Projects Database; Dose; Funding; Goals; Grant; Influenza; Institution; Intramuscular Injections; Personal Satisfaction; Phase; Range; Research; Research Personnel; Resources; Safety; Source; Treatment Protocols; United States National Institutes of Health; Vaccines; Vero Cells; base; dosage; immunogenicity; influenzavirus; novel

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 goals of this study are to assess the safety, reactogenicity, and immunogenicity of a novel Vero cell culture-derived whole virus (WV) influenza A/H5N1 vaccine at various dosage levels with or without aluminum hydroxide adjuvant when administered by intramuscular (IM) injection to healthy adults. We hypothesize that a dosage level in the range of 7.5 mg to 15 mg of adjuvanted WV influenza A/H5N1 vaccine, or a dosage level on the range of 7.5 mg to 45 mg of nonadjuvanted WV influenza A/H5N1 vaccine will be well tolerated and will result in acceptable immunogenicity when administered in a 2-dose regimen. Further, we hypothesize that addition of aluminum hydroxide adjuvant will significantly enhance the immunogenicity of the vaccine when similar dosage levels of adjuvanted and nonadjuvanted vaccine (based on HA content) are compared.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究的目的是评估新型Vero细胞培养的全部病毒（WV）流感的安全性，反应性和免疫原性，当通过肌内（IM）注射对健康的成年人的肌内（IM）注射时，在各种剂量水平上具有各种剂量水平，并没有羟化氢氧化物佐剂。我们假设在7.5 mg至15 mg的WV型WV流感A/H5N1疫苗范围内的剂量水平在7.5 mg至45 mg 45毫克的非持续的WV型WV流感A/H5N1疫苗的范围内会受到2次的耐受性，并且在2.5 mg至45 mg的剂量水平上会受到2次的良好性。此外，我们假设在比较类似的辅助疫苗（基于HA含量）时，添加氢氧化铝佐剂将显着增强疫苗的免疫原性。