H7N9 Boost in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will be an open-label phase 2 clinical trial of a single dose of an inactivated
      H7N9 influenza vaccine (non-adjuvanted). The subjects of the study will have previously
      participated in DMID trial 07-0023, evaluating inactivated Influenza A/H7N7 vaccine. In the
      previous study healthy adults 18 to 40 years old were randomized to receive two doses, 28
      days apart, of placebo or 7.5, 15, 45, or 90 ug of the influenza vaccine by IM injection in a
      1:1 ratio (N=25/vaccine group and 25 in placebo group). The primary objectives are to 1)
      assess the safety and reactogenicity of a single dose A/H7N9 vaccine in individuals who
      previously received two IM doses of an A/H7N7 vaccine or are A/H7 vaccine-naïve and 2) To
      assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9
      approximately 28 days following receipt of a single dose of A/H7N9 vaccine in individuals who
      previously received two IM doses of A/H7N7 vaccine or are A/H7 vaccine-naïve.
    

Detailed description: 
      This is a Phase II, open-label study in up to 50 males and non-pregnant females, 19 to 50
      years old, inclusive, who are in good health and meet all entry criteria. The study is
      designed to assess the safety, reactogenicity, and immunogenicity of a single dose of a
      monovalent inactivated influenza A/H7N9 virus vaccine (45 mcg of HA/0.75 mL) manufactured by
      Sanofi Pasteur administered to healthy adults who previously received two doses of monovalent
      inactivated influenza A/H7N7 virus vaccine manufactured by Sanofi Pasteur or one or two doses
      of placebo in Protocol 07-0023. All subjects will receive a single dose of the inactivated
      influenza A/H7N9 vaccine delivered intramuscularly. Reactogenicity will be measured by the
      occurrence of solicited injection site and systemic reactions from the time of the study
      vaccination Day 1/Visit 01 through 8 days after the study vaccination. Unsolicited
      non-serious adverse events (AEs) will be collected from the time of the study vaccination
      through roughly 28 days after the study vaccination. Serious adverse events (SAEs) and
      new-onset chronic medical conditions will be collected from the time of the study vaccination
      through roughly 6 months after the study vaccination. Immunogenicity testing against A/H7N9
      and A/H7N7 antigens will include performing hemagglutination inhibition (HAI) and
      neutralizing (Neut) antibody assays on serum obtained immediately prior to the study
      vaccination, and roughly 8 and 28 days after the study vaccination.

      An additional 60 mL of venous blood will be drawn immediately prior to the study vaccination,
      and roughly 8 and 28 days after the study vaccination for exploratory cellular immunology
      assays.

      The duration of this study for each subject will be roughly 6 months. The primary objectives
      are 1. to assess the safety and reactogenicity of a single dose monovalent inactivated
      influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses
      of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 2. To
      assess the serum hemagglutination inhibition (HAI) antibody responses against A/H7N9 roughly
      28 days following receipt of a single dose of a monovalent inactivated influenza A/H7N9 virus
      vaccine in individuals who previously received two intramuscular doses of a monovalent
      inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve.

      The secondary objectives are 1. To assess study-vaccine related unsolicited non-serious
      adverse events following receipt of one dose of a monovalent inactivated influenza A/H7N9
      virus vaccine in individuals who previously received two intramuscular doses of a monovalent
      inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 2. To assess new-onset
      chronic medical conditions following receipt of one dose of a monovalent inactivated
      influenza A/H7N9 virus vaccine in individuals who previously received two intramuscular doses
      of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve.3) To
      assess the serum HAI antibody responses against A/H7N9 at baseline and about 8 days following
      receipt of a single dose of a monovalent inactivated influenza A/H7N9 virus vaccine in
      individuals who previously received two intramuscular doses of a monovalent inactivated
      influenza A/H7N7 virus vaccine or are A/H7 vaccine-naïve. 4. To assess the serum neutralizing
      (Neut) antibody responses against A/H7N9 at baseline and roughly 8 and 28 days following
      receipt of a one dose of a monovalent inactivated influenza A/H7N7 virus vaccine or are A/H7
      vaccine-naïve.
    

Intervention name(s): Monovalent influenza A/H7N9 virus vaccine
Intervention type(s): Biological
Intervention description(s): Monovalent influenza A/H7N9 virus vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza,Open-Label, Vaccine, Intramusclar, H7N7, H7N9, Non-adjuvanted, sub-study