Pandemic Influenza Plasmid DNA Vaccines (Needle)
Phase 1
Completed
- Conditions
- Influenza
- Registration Number
- NCT00709800
- Lead Sponsor
- Vical
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety and Tolerability of VCL-IPT1 and VCL-IPM1 in adult subjects 6 months
- Secondary Outcome Measures
Name Time Method Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 6 months
Trial Locations
- Locations (3)
Accelovance
🇺🇸San Diego, California, United States
SNBL
🇺🇸Baltimore, Maryland, United States
SUNY at Stonybrook, Stony Brook Medical Center
🇺🇸Stony Brook, New York, United States
Accelovance🇺🇸San Diego, California, United States