Group Study of the Safety of and Immune Response to a Single Dose of Bird Flu Vaccine (H7N3) in Healthy Adults

The current pandemic risk associated with avian influenza H7N3 infection is significant, as
an increasing number of humans are infected. H7 influenza transmission usually occurs in
humans when they are exposed through direct contact to infected poultry or surfaces and
objects contaminated by infected poultry feces. A pandemic occurs when a new influenza
subtype emerges that infects humans, causes serious illness, and spreads easily between
humans. The development of a safe and effective vaccine is necessary. The purpose of this
study is to evaluate the safety and immunogenicity of a one-dose administration of the live,
attenuated AI virus vaccine, H7N3 (6-2) AA ca Recombinant (A/chicken/British
Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca).

This study will last approximately 180 days. Participation in this study includes one 12-day
hospital stay in an isolation unit at the University of Rochester Vaccine Evaluation
Isolation Unit at St. Mary's Hospital in Rochester, NY. All participants will receive one
dose of vaccine in nasal spray form at study entry. Participants will be admitted to the
isolation unit 2 days prior to vaccination. A targeted physical exam, vital signs
measurement, and nasal wash will occur daily following each vaccination until discharge.
Participants will be discharged after two consecutive nasal washes on or after Day 7 are
negative. Blood and urine collection will occur at selected timepoints throughout the study.
Follow-up outpatient visits will occur approximately at Days 28, 56, and 180. A nasal wash
and adverse events evaluation will occur at each follow-up visit.