GeoVax Starts 2 New HIV/AIDS Vaccine Human Trials
HIV/AIDS Vaccine Human Trials
GeoVax Labs starts 2 new AIDS vaccine clinical (human) trials.
These FDA compliant trials were previously scheduled to start later in 2007 and are the 3rd and 4th in a 4 clinical trial series intended to evaluate both human safety and immune responses to GeoVax's HIV/AIDS vaccines.
GeoVax's vaccines are designed to prevent Acquired Immunodeficiency Disease ("AIDS") in humans caused by the virus known as HIV-1 (Human Immunodeficiency Virus), by vaccinating individuals with its DNA and MVA vaccines prior to infection with the virus.
Starting April 2006, the 1st of these 4 human trials evaluated a low dose (1/10th of the vaccine dose) vaccination program. Preliminary results from this blinded trial demonstrated excellent vaccine safety and positive anti- HIV-1 immune responses to the vaccine in 9 of 11 participants where 9 people received GeoVax HIV/AIDS vaccines and 2 received placebos. All trial participants were normal healthy individuals. Final results will be compiled for later public release.
The 2nd of 4 human trials, initiated September 2006, was designed to evaluate results from full dose administration of GeoVax HIV/AIDS vaccines. Recent data indicates excellent safety in this full dose trial. Additional results from ancillary testing conducted at Emory University by Dr. Harriet Robinson demonstrated positive anti-HIV-1 immune responses in the majority of vaccine recipients. Official immune response data will be available later this year.
Excellent results from the 1st and 2nd trial of this 4 trial series have allowed the accelerated start of human trials #3 and #4. These trials began more than a month earlier than originally anticipated.
Due to exceptionally good results, GeoVax's scientific team believes its vaccine may perform equally as well in trial #3 which administers fewer vaccine doses and trial #4 which utilizes only GeoVax's MVA vaccine. "Success in these trials could lead to a simpler vaccine regime making it easier to vaccinate people," stated Dr. Harriet Robinson, PhD., GeoVax's Co-founder and Scientific Advisory Board Chairperson.
Don Hildebrand, GeoVax CEO/President/Co-founder, commented, "We are pleased with the results obtained to date from our ongoing full dose vaccine human trial. The excellent vaccine safety profile demonstrated was key to accelerating the start date of these new human trials. Equally important are the positive immune responses observed in people receiving only 1/10th of a dose of our vaccines. This is very encouraging news."
These human trials, utilizing GeoVax's AIDS vaccines, are conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded and supported by the National Institutes of Health (NIH), is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax's DNA and MVA vaccines was also funded and supported by the National Institutes of Health and National Institute of Allergy and Infectious Diseases.