INFLUENZA A/H5N1 VACCINE GIVEN ALONE OR WITH ALUMINUM HYDROXIDE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 大约600名年龄在65岁及以上的健康成人将参加这项随机、对照、剂量范围的临床试验。符合研究条件的受试者将被随机分成8组，分别接种含3.75、7.5、15或45微克H5N1血凝素的氢氧化铝佐剂甲型H5N1流感疫苗，或不含佐剂的含3.75、7.5、15或45微克H5N1的甲型H5N1流感疫苗。受试者将接受相隔大约28天的两次肌肉注射疫苗。疫苗管理将由一名非盲目的疫苗管理员执行，他不会参与后续评估。接种后将在诊所观察受试者至少15分钟，受试者将在每次接种后七天内保持记忆辅助器，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后的第2天和第8天返回诊所，对记忆辅助、AE和伴随的药物评估进行审查，并进行有针对性的体检(如果有)。免疫原性评估的血清将在每次免疫前、每次免疫后大约一个月和第二剂疫苗接种后六个月获得。在接种第一剂疫苗后，在开始接种第二剂疫苗之前，安全监测委员会(SMC)会议期间可获得的所有七天安全数据将由SMC进行审查。

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.