A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines Administered With the Biojector® 2000 Needle-Free System

Vical3 sites in 1 country47 target enrollmentAugust 2007

ConditionsInfluenza

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza
Sponsor: Vical
Enrollment: 47
Locations: 3
Primary Endpoint: Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with the Biojector® 2000, 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's response will be studied throughout the trial.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

February 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 to 45 years of age
•Able to provide informed consent and be followed for 6 months

Exclusion Criteria

•No immunomodulatory therapy within the past 6 months
•No evidence of immunodeficiency or pregnancy
•No laboratory or evidence of clinically significant medical disease
•No history of previous pDNA immunization
•No influenza immunization within the past 30 days
•No blood donations within 30 days of screening visit
•No history of bleeding disorder
•No use of aspirin and/or anticoagulants within 2 weeks of the administration of the investigational vaccines