H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses
Condition: Avian Influenza; H1N1 Influenza; Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single center, randomized, partially-blinded, Phase II, small, targeted,
      prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18
      to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an
      intramuscular monovalent inactivated influenza A/H7N9 virus vaccine given with and without
      AS03 adjuvant, and an intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v
      virus vaccine. The primary objectives are (1) assessing the serum anti-HA
      hemagglutination-inhibition (HAI) response to influenza A/H7N9 antigen (with and without
      adjuvant) at Day 57 (approximately one month after the second study vaccination with A/H7N9
      vaccine with or without AS03) and influenza A/H3N2v antigen at Day 29 (approximately one
      month after the study vaccination with A/H3N2v), and (2) identifying differentially expressed
      genes in human immune cells on Days 2, 4, and 29 (following the first study vaccination with
      A/H7N9 vaccine with or without AS03) and on Days 30, 32, and 36 (following the second study
      vaccination with A/H7N9 vaccine with or without AS03), compared to baseline assessments
      performed prior to each study vaccination (Days -7, 1, and 29).
    

Detailed description: 
      This is a single center, randomized, partially-blinded, Phase II, small, targeted,
      prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18
      to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an
      intramuscular monovalent inactivated influenza A/H7N9 virus vaccine manufactured by Sanofi
      Pasteur given with and without AS03 adjuvant manufactured by GlaxoSmithKline, and an
      intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v virus vaccine
      manufactured by Sanofi Pasteur. The primary objectives are (1) assessing the serum anti-HA
      hemagglutination-inhibition (HAI) response to influenza A/H7N9 antigen (with and without
      adjuvant) at Day 57 (approximately one month after the second study vaccination with A/H7N9
      vaccine with or without AS03) and influenza A/H3N2v antigen at Day 29 (approximately one
      month after the study vaccination with A/H3N2v), and (2) identifying differentially expressed
      genes in human immune cells on Days 2, 4, and 29 (following the first study vaccination with
      A/H7N9 vaccine with or without AS03) and on Days 30, 32, and 36 (following the second study
      vaccination with A/H7N9 vaccine with or without AS03), compared to baseline assessments
      performed prior to each study vaccination (Days -7, 1, and 29). The secondary objectives are:
      (1) compare plasma cytokine and chemokine profiles at specific time points and between
      treatment arms at post vaccination points, (2) assess the neutralizing antibody responses to
      influenza A/H7N9 antigen (with and without adjuvant) at Day 57 (approximately one month after
      the second study vaccination with A/H7N9 vaccine with or without AS03) and influenza A/H3N2v
      antigen at Day 29 (approximately one month after the study vaccination with A/H3N2v vaccine),
      and (3) identify differentially expressed genes in human immune cells on Days 2, 4, and 8
      following one intramuscular dose of influenza A/H3N2v vaccine compared to baseline
      assessments performed prior to study vaccination (Day -7 and Day 1).
    

Intervention name(s): AS03; Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203; Monovalent influenza A/H7N9 virus vaccine
Intervention type(s): Drug; Biological; Biological
Intervention description(s): AS03 oil-in-water emulsion adjuvant.; Inactivated monovalent subvirion H3N2v vaccine containing hemagglutinin (HA) of A/Minnesota/11/2010 NYMC X-203 virus.; Monovalent influenza A/H7N9 virus vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: A/H5N1; A/H7N9; ASO3 Adjuvant; influenza; monovalent; pH1N1; vaccines