Influenza
Conditions
Keywords
Pandemic Influenza, Avian Influenza, DNA Vaccines, Antibody, T Cells, HA/NP/M2, Biojector
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.
Interventions
Sponsors
Vical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 | 6 months |
Countries
United States
Outcome results
None listed