Dec 1 2008
GeoVax Labs, Inc. has announced that the launch of its Phase 2a Human Vaccine Trials will take place in twelve sites across North and South America.
These trials are conducted in collaboration with The National Institutes of Health (NIH), and the HIV Vaccine Trials Network (HVTN).
"It is of significant importance to report this major development on this very day in which the world commemorates WORLD AIDS DAY. Despite setbacks reported recently with other vaccine trials, our vaccine is progressing and paving the way for a solution that would potentially make this commemorative day more joyful," commented Dr. Robert McNally, GeoVax's President and CEO.
Dr. Harriet Robinson, Vice President of Research and Development of GeoVax Labs, Inc., stated, "We feel privileged to be in the position to launch our Phase 2a human trial. Going forward, each clinical site's review board will start the vaccination process, when deemed appropriate and ready. Accordingly, HVTN's pharmacy will release the vaccines to each designated institution as directed by each site's local review board."
Trial site arrangements and other details of the study were confirmed in a recent meeting held in Seattle, Washington, between the HVTN and GeoVax's scientific personnel. The Phase 2a human clinical trial will involve 150 vaccinees and 75 placebo (control) participants. The vaccine regimen employs a two-component "prime-boost strategy." Trial participants will first be administered a GeoVax HIV-1 DNA vaccine which "primes" the immune system followed by the second vaccine, GeoVax's HIV-1 MVA (Modified Vaccinia Virus) boost. Both vaccines express the three major proteins of the AIDS virus. These proteins mimic more than 50% of the components of the AIDS virus (HIV-1) but cannot cause AIDS. GeoVax AIDS vaccines are designed to prevent HIV-1 virus infection which causes Acquired Immunodeficiency Disease (AIDS).
The Seattle meeting also achieved further progress with GeoVax's therapeutic trial. Information on this and other developments will be reported in a timely fashion in the near future.