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

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

Conditions

• Healthy

Interventions

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.

Sponsors & Collaborators

• Inovio Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Mark Bagarazzi, M.D. · Inovio Pharmaceuticals

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2013-08-31

Completion

2013-08-31

Countries

• United States

Study Locations