Production of seasonal candidate plasmid DNA vaccines for use in human clinical trials. It is expected that these vaccines will be tested for safety and efficacy in Phase I trials in humans alone or as part of prime boost regimens. If found to be safe, these vaccines may proceed to testing in advanced clinical development programs. Several different serotypes of influenza vaccines are being manufactured, filled and released in compliance with current Good Manufacturing Practices (cGMP) that will be tested in preclinical (animal) challenge-efficacy studies.
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