Phase 1b Influenza Vaccine Study in Healthy Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see whether a single vaccination (injection) with the
      investigational influenza vaccine is safe in healthy subjects. The study is also designed to
      evaluate four different dose formulations of the vaccine to see which gives the best immune
      response.
    

Detailed description: 
      Prophylactic vaccination against influenza is indicated for "at risk" populations including
      patients suffering from chronic respiratory diseases (including asthma), chronic heart
      disease, chronic renal failure, diabetes mellitus and immunosuppression due to disease or
      treatment. Vaccination of the elderly (>65 years) and the residents of nursing homes is also
      recommended. The current influenza vaccines available contain subunits from two influenza A
      viruses and an influenza B virus and consist either of inactivated whole virus or subunits of
      haemagglutinin and neuraminidase.

      The investigational influenza vaccine (FLU-v) contains multiple highly conserved T cell
      epitopes that are present on most influenza viruses, which have been identified as reactive
      in different human leukocyte antigen (HLA) populations; thus making it unlikely that anybody
      in the vaccinated population would be unable to mount an immune response to at least one of
      the epitopes contained in the vaccine.

      This study will be the initial exploration of FLU-v in humans, and aims to assess the safety,
      tolerability, and immunogenicity in healthy subjects.

      Subjects will be randomised to receive either Low Dose or High Dose FLU-v with or without
      adjuvant, or placebo with or without adjuvant. Twenty-four (24) subjects will be randomized
      to Low Dose and 24 subjects to High Dose. To mitigate risk, a staggered dosing approach will
      be used. One subject will receive Low Dose FLU-v without adjuvant, and one subject will
      receive placebo without adjuvant, followed 6 hours later by one subject receiving Low Dose
      FLU-v with adjuvant, and one subject receiving placebo with adjuvant. All 4 subjects will be
      observed overnight. At least 72 hours later and in the absence of any clinically-significant
      safety signals (as determined by a Safety Review Committee) the remaining 20 subjects of the
      Low Dose group will be dosed. If deemed appropriate by the Safety Review Committee a second
      sentinel cohort of 4 subjects will be observed overnight prior to completing the remaining
      subjects of the Low Dose group. Following a satisfactory review of safety data from the
      combined Low Dose cohorts, subjects in the High Dose group will be vaccinated using the same
      staggered dosing approach as used in Low Dose.
    

Intervention name(s): Influenza vaccine (FLU-v); FLU-v Control
Intervention type(s): Biological; Biological
Intervention description(s): Comparison of different dosages of FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection of (Low Dose / High Dose with adjuvant / water for injection); Adjuvant only or water for injection only Administration: a single subcutaneous injection
Other intervention name(s): FLU-v
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Tolerability; Immunogenicity; Influenza; Virus; Vaccine