Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Influenza is a virus infection that causes sickness from the nose to the lungs. It is thought
      that type 1 interferon (a protein that helps the immune system fight viruses) will make flu
      vaccines more effective. This study will determine if type 1 interferon added to a specific
      flu vaccine will help the immune system of healthy adults fight off infection better than
      vaccine alone. Ninety volunteers, ages 18-40, will participate in this study. They will
      attend 3 study visits and have a final follow-up study visit, email, or phone call about six
      months after the vaccination. Volunteers will receive a single dose of study vaccine sprayed
      into the nose. Study procedures including blood samples and nasal washes (the inside of the
      nose is washed out) will be collected to evaluate immune system responses.
    

Detailed description: 
      Influenza is primarily a virus infection of the respiratory tract mucosa from the nose to the
      terminal bronchioles. Immunity to influenza virus infection is mediated primarily by antibody
      in respiratory secretions at the mucosal surface. To meet the need for improved inactivated
      vaccines, one potential approach is to increase the frequency and magnitude of antibody in
      secretions by administering inactivated influenza virus vaccine (IVV) intranasally and to
      optimize responses by including a mucosal adjuvant. The primary hypothesis of this study is
      that Type 1 interferon (IFN) will provide an adjuvant effect at the respiratory mucosal
      surface for production of IgA and/or IgG antibody to the influenza strains when added to IVV
      and administered intranasally. The primary objective of the study is to determine whether
      including type 1 IFN with IVV, administered intranasally, to healthy adults will enhance
      antibody responses in nasal secretions compared to intranasal administration of IVV alone.
      This is a single-center, randomized, double-blind, clinical trial to determine if type 1 IFN
      will act as a mucosal adjuvant for antibody responses to influenza viruses after
      administration with IVV intranasally. Subjects will be healthy adults between the ages of 18
      and 40. The study will enroll 30 subjects in each of three groups, a group given 0.6 ml of
      IVV, a group given 0.6 ml of IVV containing 1M units of IFN and a group given 0.7 ml of IVV
      containing 10M units of IFN. The vaccine or vaccine/interferon combination will be
      administered to the subjects intranasally once. Blood and nasal secretions will be obtained
      before vaccination and again two and four weeks after immunization. Each subject will be
      asked to complete a memory aid for seven days and to report any unexpected adverse events
      (AEs) to study personnel. The subject will report to the clinic or be contacted by phone or
      e-mail at six months after vaccination regarding occurrence of any unreported serious adverse
      events (SAEs). The three nasal secretions will be used for testing for IgA and IgG antibody
      to the A/H1N1 and A/H3N2 HA in enzyme-linked immunosorbent assay (ELISA) tests. The three
      blood samples will be tested in HAI and neutralization tests for antibody to the A/H1N1 and
      A/H3N2 vaccine antigens.
    

Intervention name(s): Trivalent inactivated influenza virus vaccine (2006-2007 formulation); Type 1 interferon
Intervention type(s): Biological; Biological
Intervention description(s): Commercially available trivalent inactivated influenza virus vaccine without or with 1 of 2 dosages of commercially available type 1 interferon administered once by nasal instillation. Dosages: 0.6 ml of IVV or 0.7 ml of IVV.; Commercially available lyophilized IFN; dosages 1 M unit (Mu) of IFN; 10 M units (Mu) of IFN.
Intervention MeSH terms: Interferons
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: interferon, vaccine, influenza