INFLUENZA A/H5N1 VACCINE GIVEN ALONE OR WITH ALUMINUM HYDROXIDE

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。子项目和 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 ug H5 N1血凝素（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 ug H5 N1无佐剂甲型H5 N1流感疫苗。 受试者将接受两次肌肉注射疫苗，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。 接种后将在诊所观察受试者至少15分钟，受试者将在每次免疫接种后7天内保持记忆辅助，以记录口腔温度以及全身和局部不良事件（AE）。 受试者将在每次免疫接种后第2天和第8天返回诊所，以审查记忆辅助、AE和伴随药物评估，并进行有针对性的体格检查（如有指征）。 将在每次免疫接种前、每次免疫接种后约1个月和接种第二剂疫苗后6个月获得用于免疫原性评价的血清。 在接种第一剂疫苗后，在开始接种第二剂疫苗前，SMC将审查安全性监查委员会（SMC）会议时获得的所有7天安全性数据。

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 ug of H5N1 hemagglutinin (HA), or influenza A/H5N1 vaccine containing 3.75, 7.5 15 or 45 ug of H5N1 without adjuvant. Subjects will receive two intramuscular 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 adverse events (AE) for seven 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 each immunization, approximately one month after each immunization, and six months after receipt of the second dose of vaccine. Following administration of the first dose of the vaccine, all seven day safety data available at the time of the safety monitoring committee (SMC) meeting will be reviewed by the SMC prior to initiating administration of the second dose of vaccine.