CLINICAL TRIAL: INFLUENZA VACCINE ALONE OR WITH ALUMINUM HYDROXIDE TO HEALTHY YO

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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. The purpose of this study is to determine the safety and effectiveness of an avian flu vaccine given with or without an adjuvant, a substance used to boost the immune response. The information will be used to design a an avian flu vaccine which could produce an effective immune response at the lowest effective dose. This is a Phase I, multicenter, staged, randomized, double-blind, placebo-controlled, dosage ranging study of the safety, reactogenicity, and preliminary immunogenicity of a Vero cell-grown, inactivated, whole virus influenza A/H5N1 vaccine administered with or without aluminum hydroxide adjuvant by the intramuscular (IM) route as a 2-dose regimen (Day 0 and Day 28). Approximately 300 healthy young adults (aged 18 to 40 years inclusive) will be enrolled by five sites. Subjects will be enrolled over a 2-3 month period. The Stanford site expects to enroll a total of about 60 subjects-15-20 subjects in Stage 1 and 40-45 subjects in Stage 2. Each subject will be randomly assigned to receive 2 doses of either saline placebo, or 7.5 or 15 ?g of the influenza A/H5N1 virus vaccine with or without aluminum hydroxide, or 45 ?g of the influenza A/H5N1 virus vaccine without aluminum hydroxide (N=50/dose group) by IM injection. Vaccine preparation and administration will be performed by an unblinded vaccine administrator, who will not be involved in subsequent study procedures. All study assessments will be performed by blinded study personnel and subjects will be blinded as much as practical to treatment assignment. The study will be conducted in 2 stages (1 and 2). During Stage 1, 90 subjects who meet the entry criteria for the study will be randomized to receive saline placebo or 7.5 mg (with or without aluminum hydroxide), 15 mg (with or without aluminum hydroxide), or 45 mg (without aluminum hydroxide) (6 groups; N=15 per group). Blood for safety evaluations (including total white blood cell count [WBC], hemoglobin [Hgb], platelet count, alanine aminotransferase [ALT], and serum creatinine) will be obtained from all subjects in Stage 1 cohort at screening, and before and 1 week after each vaccination. The Safety Monitoring Committee (SMC) will meet approximately 10 days after enrollment and completion of first vaccination of subjects in Stage 1 to review available clinical and laboratory safety data. If no clinical or laboratory safety-related issues or dose-limiting toxicities are noted during the week after administration of the first dose of vaccine during Stage 1, then all Stage 1 subjects will receive second vaccination. Furthermore, the SMC will meet to review a complete clinical and laboratory safety data package for Stage 1 prior to initiation of the enrollment of 210 additional subjects into each vaccine group during Stage 2 (N=50 per group total).