PHASE I, OPEN-LABEL, SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF AN H5 INFLUENZA PLASMID VACCINE (INO-3401) IN HEALTHY ADULTS PREVIOUSLY VACCINATED WITH VGX-3400X
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, INO-3401, 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 up 30 healthy adult subjects who have participated in study FLU-001. It is hypothesized that a booster dose with INO-3401 + EP will be well tolerated and immunogenic.
Phase I, Open Label Study to Evaluate Safety, Tolerability and Immunogenicity of Multiple Combinations of H1 and H5 Influenza Hemagglutinin Plasmids Administered ID Followed by in Vivo Electroporation With CELLECTRA®-3P in Healthy Adults
This is a Phase I, parallel design open label study to evaluate safety, tolerability and immunogenicity of nine different formulation of two individual H1 and one H5 HA plasmid administered intradermally followed by electroporation in healthy adults
100 项与 INO-3401 相关的专利(医药)