INFLUENZA A/H5N1 VACCINE GIVEN ALONE OR WITH ALUMINUM HYDROXIDE

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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.