Evaluating the Safety and Immune Response to a Live H7N9 Influenza Virus Vaccine Followed by an Inactivated H7N9 Influenza Virus Vaccine, Given at Varying Intervals
Condition: Influenza A Virus, H7N9 Subtype
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose
      of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca
      influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying
      intervals.
    

Detailed description: 
      H7N9 avian influenza (AI) viruses have been responsible for a recent outbreak of illness in
      humans in China, which was associated with severe respiratory illnesses resulting in acute
      respiratory distress syndrome (ARDS) and intensive care unit (ICU) admissions. The purpose of
      this study is to evaluate the safety, infectivity, and immunogenicity of a live attenuated
      H7N9 A/Anhui/13 cold adapted (ca) influenza virus vaccine followed by a boost with an
      inactivated subvirion H7N9 vaccine at varying intervals.

      This study will enroll participants into five cohorts. Participants in Cohorts 1, 2, 3, and 4
      will be admitted to an isolation unit on Study Day -2. On Study Day 0, participants will
      receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine via a nose spray device.
      While in the isolation unit, participants will undergo a physical examination and nasal wash
      each day, and a blood collection on select days. Participants will remain in the isolation
      unit for at least 9 days after receiving the vaccine, but possibly longer, depending on their
      test results.

      Participants in Cohorts 1 and 2 will return to the isolation unit 4 to 8 weeks after
      receiving the first vaccine (at approximately Day 28). They will receive the second dose of
      the H7N9 A/Anhui/13 ca influenza virus vaccine and repeat all of the same procedures that
      occurred after the first vaccination.

      Participants will then receive one dose of the inactivated subvirion H7N9 vaccine 1 month
      (Cohort 1) or 2 months (Cohort 2) after receiving the second vaccine.

      Participants in Cohorts 3 and 4 will receive the inactivated subvirion H7N9 vaccine either 1
      month (Cohort 4) or 2 months (Cohort 3) after receiving one dose of the live attenuated
      vaccine. For Cohorts 1-4, participants study visits will occur 7, 14, 28, and 90 days after
      receiving the vaccine and will include a medical history review, physical examination, and
      blood collection at select visits.

      Participants in Cohort 5 will receive one dose of the inactivated subvirion H7N9 vaccine at
      Day 0 and one dose at Day 28. Study visits will occur on Days 0, 7, 28, 35, 42, 56, and 118,
      and will include blood collections and physical examinations. Participants in Cohort 5 will
      not be admitted to the isolation unit.
    

Intervention name(s): H7N9 A/Anhui/13 ca influenza virus vaccine; Inactivated subvirion H7N9 vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Participants will receive approximately 10^7.0 fluorescent focus units (FFU) of the vaccine; the vaccine will be administered with a nose spray device.; Participants will receive a dose of 30 mcg of the vaccine; the vaccine will be administered as an injection.
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention