ATLANTA, Oct. 20 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta based biotechnology company, developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, announced today it has shipped both DNA and MVA components of its AIDS vaccine to the HIV Vaccine Trials Network (HVTN) pharmacy, for use in the upcoming Phase 2a human clinical trial. This Phase 2a study will involve 150 vaccinees and 75 placebo (control) participants. These trials serve as a major milestone, as Phase 2a trials are the most advanced trials to-date for GeoVax.
Dr. Robert McNally, President and CEO of GeoVax Labs Inc., commented, "The shipment of the vaccine to the HIV Vaccine Trials Network is a significant step in preparation for the largest clinical trial yet to be undertaken by GeoVax. Multiple completed Phase 1 safety trials refined the dose and vaccine delivery intervals to optimize the immune responses considered desirable to achieve protection against the HIV-1 virus causing AIDS."
Further, a Biological Master File has been submitted to the Food and Drug Administration (FDA) for review of the manufacturing data for the product shipped to HVTN for use in the Phase 2a trial. The FDA completes its review within four weeks. Upon FDA clearance, HVTN's pharmacy will release GeoVax's DNA and MVA vaccines for its planned Phase 2a trial commencement.
GeoVax AIDS vaccines are designed to prevent development of Acquired
Immunodeficiency Disease (AIDS) caused by the virus known as HIV-1 by
vaccinating individuals prior to virus infection. The vaccine regimen
employs a two component "prime-boost strategy." Trial participants are
first administered 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 3 major proteins of the
AIDS virus. These proteins mimic more than 50% of the
|SOURCE GeoVax Labs, Inc.|
Copyright©2008 PR Newswire.
All rights reserved