Immunogenicity and Safety of Live Attenuated Influenza Vaccine (Flumist) Administered by Nasal and Sublingual Route
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Background: It is well established that live attenuated organisms can be highly effective
      vaccines, immune responses elicited can often be of greater magnitude and of longer duration
      than those produced by non-living antigens and are often able to confer protection after a
      single dose. Unlike killed influenza vaccine preparations injected by the parenteral route,
      live influenza vaccines are able to induce potent secretory (mainly IgA) antibody responses
      in the airway mucosae and can also evoke cell mediated responses. T cell proliferation,
      cytokine production, cytotoxic T cell responses and antibody-dependent cell cytotoxicity have
      all been elicited by live attenuated vaccines.

      There has been a history of the use of live attenuated flu vaccines as safe and effective
      vaccines for the prevention of flu in animals and humans. Live-attenuated cold-adapted
      influenza vaccines have been proved to be highly efficacious to protect against clinical fly
      symptoms. Among these, FluMist, a nasal vaccine formulation developed by Medimmune Inc, has
      been approved by the US FDA. Recent side by side clinical trials have demonstrated that this
      nasal vaccine was significantly superior to conventional killed flu vaccine in protecting
      against flu symptoms.

      Sublingual administration of live influenza virus at a dose lethal by the nasal route was
      well tolerated and did not redirect virus to the olfactory bulb. In addition, in a recent
      Phase I clinical study (NCT00820144) conducted in France, the sublingual administration of
      recombinant cholera toxin B subunit (rCTB,up to 1 mg) in healthy adult volunteers was found
      to be safe.

      A major issue has arisen regarding the ease with which vaccines could be administered to
      young children, especially infants, and to elderly subjects in whom nasal vaccination has not
      been possible and/or approved due to difficulties of administering nasal vaccines in infants
      and to undesired side effects related to frequent rhinitis and sneezing episodes in elderly
      subjects. This study is designed to investigate the safety, tolerability and immunogenicity
      of a new route of administration of vaccines, using the nasal FluMist formulation as
      prototype vaccine.

      Objectives: To evaluate the immunogenicity and safety of a nasal and sublingual influenza
      virus vaccine (FluMist) in healthy adult volunteers

      Study design: This will be a randomized study on a total 40 subjects; each 20 subjects will
      receive vaccine via nasal and sublingual route, respectively
    


Intervention name(s): Influenza vaccine; Influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Administration of 1 dose (0.2 ml) by nasal route; Administration of 1 dose (0.2 ml) by sublingual route
Other intervention name(s): Flumist (2011-2012); Flumist (2011-2012)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Influenza vaccine; nasal route; sublingual route; immunogenicity; safety