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

NCT01405885 Phase 1 COMPLETED

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

Details

Lead sponsor	Inovio Pharmaceuticals
Phase	Phase 1
Status	COMPLETED
Enrolment	116
Start date	2011-05
Completion	2013-08

Conditions

• Healthy

Interventions

• INO-3605
• INO-3609
• INO-3401
• INO-3609
• INO-3605 AND INO-3609
• INO-3510
• INO-3609
• INO-3609
• Seasonal Influenza vaccine
• INO-3609

Primary outcomes

• Safety and tolerability of nine different formulation of multiple combination of H1 and H5 HA plasmid administered ID followed by electroporation in healthy adult subjects — Day 0 through Month 12
  Frequency and severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events

Countries

United States