Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains that infect people is important. The purpose of this study is to determine the safety of and immune response of an investigational AI vaccine in healthy adults against the H7N3 strain of avian influenza.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Vaccine administered by nasal spray
University of Rochester Vaccine Evaluation Isolation Unit, St. Mary's Hospital
Rochester, New York, United States
Frequency of vaccine-related reactogenicity events
Time frame: During inpatient stage
Area under the curve of nasal viral shedding
Time frame: Days 2 through 9
Development of serum antibody assessed by either HAI or MN assays
Time frame: Throughout study
Number of participants infected with the recombinant vaccine candidate
Time frame: Throughout study
T-cell mediated and innate immune responses against recombinant vaccine candidate
Time frame: Throughout study
Development of serum bank for testing effectiveness of vaccine against future viruses
Time frame: Throughout study
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Enrollment
20