Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Flublok™ Quadrivalent by Sanofi, Inc.; VaxigripTetra™ by Sanofi, Inc.
Intervention description: 0.5 mL intramuscular dose of Flublok; 0.5 mL intramuscular dose of Vaxigrip
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: Open-label trial. Eligible HCP who report already having been vaccinated with Vaxigrip at the time they are approached to join the study will be eligible to participate.
Enrollment: 577.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Healthcare personnel; Immunogenicity; Repeat vaccination

Summary:

      This randomized, open-label, active-controlled trial will assess humoral immune responses to
      a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4)
      compared with standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among
      healthcare personnel (HCP) vaccinated during the previous 2018-19 season with IIV4. The trial
      will be conducted at two hospital sites in Israel during the 2019-20 influenza season among
      HCP who were enrolled in the Study of Healthcare Personnel with Influenza and other
      Respiratory Viruses in Israel (SHIRI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥18

          -  Current member of Clalit Health Services

          -  Consent to randomized receipt of influenza vaccination with either RIV4 or IIV4, or,
             if already vaccinated in the current year outside of the study, consent to receive a
             post-vaccination blood draw

          -  Participated in the SHIRI study and received influenza vaccination during the 2018-19
             influenza season (Group 1)

          -  Participated in any year of the SHIRI study, not vaccinated in 2018-2019, but
             vaccinated in at least one study year (Group 1 supplemental)

          -  Participated in the SHIRI study during all three years, regardless of vaccination
             status (Group 1 supplemental)

          -  Participated in any year of the SHIRI study and had PCR-confirmed influenza virus
             infection during any of the three study years (Group 2)

        Exclusion Criteria:

          -  Already received an influenza vaccine during the current influenza season

          -  Not willing or able to get the flu vaccines being used in this study;

          -  Previous hypersensitivity reaction to the study vaccines, or any vaccine, as reported
             by the subject

          -  Received any non-influenza vaccine (e.g., Hepatitis B or other vaccine recommended for
             HCP) in the 4 weeks prior to the first study visit or plans to receive a vaccine in
             the 4 weeks following the first study visit

          -  Currently participating in a study that involves an experimental agent (vaccine, drug,
             biologic, device, blood product, or medication), or has received an experimental agent
             within 1 month prior to enrollment in this study, or expects to receive an
             experimental agent during participation in this study.

          -  Any condition or employment status that the potential participant or local study site
             principle investigator (PI) believes may interfere with successful completion of the
             study prior to December 2019, including being currently pregnant.