A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza Virus
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, parallel design open label study to evaluate safety, tolerability and
      immunogenicity of nine different formulation of two individual H1 and one H5 HA plasmid
      administered intradermally followed by electroporation in healthy adults
    

Detailed description: 
      The use of DNA plasmids containing genes that express viral antigens may be a promising way
      to formulate a vaccine that can effectively prevent infection and disease caused by the H5N1
      avian influenza virus and H1N1 influenza viruses. Plasmid vectors are simple to construct and
      are easy to manufacture at a relatively low cost. Vaccination with plasmids that express
      influenza proteins should induce the development of serum antibodies and might also induce
      significant quantities of secretory IgA antibodies and/or CMI. The DNA sequences included in
      the vaccine could also result in the proliferation of T lymphocytes that could broaden the
      effectiveness of the vaccine to include variant strains of H5N1 and H1N1 with antigenically
      modified HA (i.e., drifted strains).

      Electroporation (EP) is a technology in which a transmembrane electrical field is applied to
      increase the permeability of cell membranes to create microscopic pathways (pores) and
      thereby enhance the uptake of drugs, vaccines, or other agents into target cells. Their
      presence allows macromolecules, ions, and water to pass from one side of the membrane to the
      other. The presence of a constant field influences the kinetics of directional translocation
      of the macromolecular plasmid, such that the plasmid delivery in vivo has been sufficient to
      achieve physiological levels of secreted proteins. ID injection of a plasmid followed by EP
      has been used very successfully to deliver therapeutic genes that encode for a variety of
      hormones, cytokines, or enzymes in a variety of species. EP is currently being used in humans
      to deliver cancer vaccines and therapeutics as well as in gene therapy. The expression levels
      are increased by as much as 3 orders of magnitude over plasmid injection alone.

      The use of EP via the CELLECTRA® device should increase the expression of H5N1 and H1N1
      influenza virus genes in the study vaccines.
    

Intervention name(s): INO-3605; INO-3609; INO-3401; INO-3609; INO-3605 AND INO-3609; INO-3510; INO-3609; INO-3609; Seasonal Influenza vaccine; INO-3609
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.9mg of INO-3605 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.; 0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.; 0.9mg of 3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.; 0.3mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.; 0.45mg each of INO-3605 AND INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.; 0.3mg each of INO-3605, INO-3609 AND INO-3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.; 0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 16 and 24.; 0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0 and Week 8; 0.5ml of vaccine delivered IM; 1.8mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Universal Influenza; Intradermal DNA vaccine; Electroporation; H1 and H5; DNA Vaccination; Influenza; INO-3510