Respiratory Tract Infections Clinical Trial
Official title:
Phase I, Open Label Study of a DNA Vaccine's Ability to Increase the Immune Response to the Trivalent Seasonal Influenza Vaccine in the Elderly
The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will be safe and generally well tolerated in healthy elderly adult volunteers and will result in greater immunogenicity when used to prime the immune response to a dose of a trivalent inactivated seasonal vaccine.
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 H1N1
influenza virus. 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 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 H1N1 influenza
virus genes in the study vaccine.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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