Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

Vical

Status and phase

Completed

Phase 1

Conditions

Influenza

Treatments

Biological: PBS

Biological: VCL-IPT1

Biological: VCL-IPM1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00694213

IPT1-102

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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