Pandemic Influenza Plasmid DNA Vaccines (Needle)

Completed · Phase 1

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00709800

Run by

Vical

People needed

56

Starts

2007-08-01

Last updated by the study team

2009-02-12

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Accelovance — San Diego, California, United States
• SNBL — Baltimore, Maryland, United States
• SUNY at Stonybrook, Stony Brook Medical Center — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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