Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity in Healthy Adult Males of a DNA Plasmid Vaccine for HS Avian Influenza (VGX-3400) Administered by Intramuscular (IM) Injection Followed by Electroporation (EP)
Research Hypothesis: VGX-3400 (DNA plasmids encoding the hemagglutinin (HA), neuraminidase (NA), and M2e-NP antigen of the H5N1 avian influenza virus) administered to healthy adult males by IM injection followed by EP will be generally well tolerated and immunogenic.
Phase I, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity in Healthy Adults of a DNA Plasmid Vaccine for H5 Avian Influenza (VGX-3400X) Administered by Intramuscular (IM) Injection Followed by Electroporation (EP)
DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans. The investigators have developed a DNA vaccine, VGX-3400X, which includes plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will be delivered via electroporation (EP) which uses the CELLECTRA constant current device to deliver a small electric charge following injection, since animal studies have shown that this delivery method increases the immune response to vaccine. The vaccine will be given to 30 healthy adult subjects. It is hypothesized that VGX-3400X + EP will be well tolerated and immunogenic.
100 项与 VGX-3400 相关的专利(医药)