Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 3/1/2019 |
| Start Date: | August 2007 |
| End Date: | February 2011 |
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
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.
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.
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
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