Safety and Immunogenicity of a Live Attenuated H7N9 Influenza Virus Vaccine in Healthy Adults
Condition: Influenza A Virus, H7N9 Subtype
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease
      in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of
      a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. A single dose
      of inactivated subvirion H7N9 influenza vaccine will be administered 3 months later.
    

Detailed description: 
      H7N9 AI viruses have recently caused a large outbreak of severe respiratory disease in humans
      in China. A vaccine for use in the event of an H7N9 AI pandemic is an important research
      priority. Previous studies have shown that when subjects who received a live bird flu vaccine
      received a subsequent "booster" dose of inactivated bird flu vaccine, a vigorous antibody
      response was detected. The inactivated vaccine served as a way to probe the immune response
      to the initial live vaccine. The purpose of this study is to evaluate the safety,
      infectivity, and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus
      vaccine in healthy adults, and to administer a booster dose of an inactivated subvirion H7N9
      influenza vaccine 3 months later.

      This study will enroll healthy adults who are willing to remain in an isolation unit in an
      inpatient clinic for several days during the study. They will be randomly assigned to receive
      either one dose (Group 1) or two doses (Group 2) of the live attenuated H7N9 A/Anhui/13 ca
      influenza virus vaccine, which will be delivered by a nasal spray device. Participants in
      both groups will receive one "booster" dose of inactivated subvirion H7N9 influenza vaccine 3
      months later in an outpatient setting. All participants will be admitted to the inpatient
      clinic and will receive one dose of the live attenuated H7N9 A/Anhui/13 ca influenza virus
      vaccine 2 days after entering the clinic. Participants will remain in the inpatient clinic
      for approximately 9 days after receiving the vaccine. While in the clinic, participants will
      undergo medical history reviews, blood collections, urine collections, physical examinations,
      nasal wash procedures, and vital sign measurements.

      Participants in Group 1 will attend a study visit at Day 28 and undergo a medical history
      review, blood collection, and a nasal wash. Participants in Group 2 will be readmitted to the
      inpatient clinic 2 days prior to receiving a second dose of the live attenuated H7N9
      A/Anhui/13 ca influenza virus vaccine at Day 28. They will remain in the clinic for
      approximately 9 days after receiving the vaccine; while in the clinic, they will take part in
      the same study procedures as during the first inpatient visit.

      All participants will attend a study visit at Day 56 and undergo a medical history review,
      blood collection, and a nasal wash. At Day 98, all participants will receive one "booster"
      dose of the inactivated subvirion H7N9 influenza vaccine, as outpatients. They will attend
      additional study visits on Days 101, 105, 112, 126, 154, and 180, which may include medical
      history reviews; physical examinations; and urine, blood, and nasal secretion collections.
    

Intervention name(s): Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine; Inactivated subvirion H7N9 influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Participants will receive approximately 10^7.0 focus forming units (FFU) of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine. The vaccine will be delivered by an Accuspray nasal spray device (0.25 mL per nostril for a total of 0.5 mL of vaccine).; Participants will receive 30 mcg of the inactivated subvirion H7N9 vaccine by intramuscular injection.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention