NCT01405885

A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza Virus

Phase I, Open Label Study to Evaluate Safety, Tolerability and Immunogenicity of Multiple Combinations of H1 and H5 Influenza Hemagglutinin Plasmids Administered ID Followed by in Vivo Electroporation With CELLECTRA®-3P in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Inovio Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	INO-3605	0.9mg of INO-3605 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
BIOLOGICAL	INO-3609	0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
BIOLOGICAL	INO-3401	0.9mg of 3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
BIOLOGICAL	INO-3609	0.3mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
BIOLOGICAL	INO-3605 AND INO-3609	0.45mg each of INO-3605 AND INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
BIOLOGICAL	INO-3510	0.3mg each of INO-3605, INO-3609 AND INO-3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
BIOLOGICAL	INO-3609	0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 16 and 24.
BIOLOGICAL	INO-3609	0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0 and Week 8
BIOLOGICAL	Seasonal Influenza vaccine	0.5ml of vaccine delivered IM
BIOLOGICAL	INO-3609	1.8mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-07-29
• Last updated: 2014-03-03

Locations

3 sites across 1 country: United States