INFLUENZA CVD 18000

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 大约600名年龄在65岁及以上的健康非卧床成人将入组这项随机、对照、剂量范围探索临床试验。符合研究入选标准的受试者将被随机分为8组，分别接受含3.75、7.5、15或45 mg H5 N1 HA的氢氧化铝佐剂甲型/H5 N1流感疫苗或含3.75、7.5、15或45 mg H5 N1无佐剂甲型/H5 N1流感疫苗。受试者将接受2次肌肉注射（IM）疫苗，间隔约28天。疫苗接种将由未设盲的疫苗接种人员进行，该人员将不参与后续评估。接种后将在门诊观察受试者至少15分钟，每次免疫后7天，受试者将保持记忆辅助记录口腔温度以及全身和局部AE。受试者将在每次免疫接种后的第2天和第8天返回诊所，审查记忆辅助工具、AE和合并用药评估，并进行有针对性的体格检查（如果有指征）。在免疫前、每次免疫后约1个月和接种第二剂疫苗后6个月采集用于免疫原性评价的血清。

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. Approximately 600 healthy ambulatory adults aged 65 years and older will be enrolled into this randomized, controlled, dose-ranging clinical trial. Subjects who meet the entry criteria for the study will be randomized into 8 groups to receive aluminum hydroxide-adjuvanted influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mg of H5N1 HA, or influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mg of H5N1 without adjuvant. Subjects will receive 2 intramuscular (IM) doses of vaccine separated by approximately 28 days. Vaccine administration will be performed by an unblinded vaccine administrator, who will not be involved in subsequent assessments. Subjects will be observed in the clinic for at least 15 minutes after inoculation, and subjects will maintain a memory aid to record oral temperature and systemic and local AEs for 7 days after each immunization. Subjects will return to the clinic on Days 2 and 8 after each immunization for a review of the memory aid, AE and concomitant medication assessment, and a targeted physical examination (if indicated). Serum for immunogenicity evaluations will be obtained before immunization, approximately 1 month after each immunization, and 6 months after receipt of the second dose of vaccine.