Evaluating the Safety and Immunogenicity of a H7N9 Vaccine for the Prevention of Influenza H7N9 Disease in Adults 50 to 70 Years Old
Condition: Influenza A Virus, H7N9 Subtype
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      H7N9 viruses have caused an outbreak of severe respiratory disease in 2013-2014 in China that
      affected many older adults. This study will evaluate the safety of and immune response to a
      live attenuated H7N9 vaccine in adults 50 to 70 years old.
    

Detailed description: 
      H7N9 viruses caused an outbreak of severe respiratory disease in China in 2013-2014, which
      was associated with severe respiratory illness, acute respiratory distress syndrome (ARDS),
      intensive care unit (ICU) admissions, and death. The outbreak affected older adults and
      highlighted the need for a vaccine that is effective in this population. Prior studies have
      demonstrated the safety and immunogenicity of a vaccination regimen in which administration
      of the experimental H7N9 vaccine (H7N9 Anhui 2013/AA ca) was followed by an H7N9 inactivated
      vaccine in younger adults. This study will evaluate the safety and immunogenicity of a
      similar vaccination regimen in healthy adults, 50 to 70 years old, who are H7N9 seronegative.

      Participants will be admitted to the inpatient unit 2 days before they will receive their
      first vaccination with the H7N9 Anhui 2013/AA ca vaccine. All participants will receive one
      dose of the H7N9 vaccine, delivered as a nasal spray, on Day 0. While in the inpatient unit,
      study procedures will include physical examinations, medical history reviews, nasal swabs,
      and blood and urine collections. On Day 9, participants will be discharged from the inpatient
      unit provided they meet certain medical criteria. If not, they will remain in the isolation
      unit until the criteria are met.

      On Day 26, participants will be readmitted to the inpatient unit, and on Day 28, they will
      receive one dose of the H7N9 vaccine delivered as a nasal spray. Participants will remain in
      the inpatient unit until Day 37 and will take part in all of the same study procedures that
      occurred during the first inpatient stay. On Day 56, all participants will attend a study
      visit for a blood collection and nasal swab. On Day 98, all participants will receive one
      dose of the inactivated subvirion H7N9 vaccine. They will attend study visits on Days 101,
      105, 112, 126, 154, and 180, which will include the same study procedures that occurred
      during the inpatient visits.
    

Intervention name(s): H7N9 Anhui 2013/AA ca; Inactivated subvirion H7N9 vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 10^7.0 fluorescent focus units (FFU); 0.5 mL of vaccine will be delivered as a nasal spray by an Accuspray device (0.25 mL per nostril); 30 mcg
Other intervention name(s): H7N9 (6-2) AA ca recombinant vaccine; A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca; H7N9 A/Anhui/13 ca pLAIV; H7N9 pIIV
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention