NCT00709800

Pandemic Influenza Plasmid DNA Vaccines (Needle)

A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Vical · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system response will be studied throughout the trial.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	VCL-IPT1	IM, 0.1 mg/mL, 2 injections, 0 and 21 days
BIOLOGICAL	VCL-IPT1	IM, 0.5 mg/mL, 2 injections, 0 and 21 days
BIOLOGICAL	VCL-IPT1	IM, 1 mg/mL, 2 injections, 0 and 21 days
BIOLOGICAL	VCL-IPM1	IM, 1 mg/mL, 2 injections, 0 and 21 days
BIOLOGICAL	PBS	IM, 1 mL, 2 injections, 0 and 21 days

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-09-01
• First posted: 2008-07-03
• Last updated: 2009-02-12

Locations

3 sites across 1 country: United States