INFLUENZA CVD 18000

点击翻译按钮获取中文摘要

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.