Human Trial Results Show Excellent Safety Data, Positive Immune Responses From GeoVax's DNA/MVA AIDS Vaccines

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geovaxATLANTA, February 05, 2007 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. , an Atlanta-based biotechnology company, today reported successful early results from two ongoing AIDS prevention Phase I human vaccine trials. Results from the first low dose trial indicate a good safety profile as well as positive immune responses in human volunteers receiving 1/10th dose of GeoVax's AIDS vaccine.

Results from a second larger full dose trial also indicate a good safety profile in participants. The GeoVax vaccines being tested are designed to prevent the development of Acquired Immunodeficiency Disease ("AIDS") caused by the virus known as HIV-1 by vaccinating individuals prior to infection with the AIDS virus.

Early results from GeoVax's preventative HIV/AIDS vaccine human trials:

  • Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006
  • Indicate that as low as 1/10th of a full dose of GeoVax's HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients
  • Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006
  • Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007
  • Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated

 

The 1/10th dose trial, begun April, 2006, is evaluating GeoVax's AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.

"We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine," said Dr. Harriet Robinson, GeoVax's Chief Scientific Advisor and developer of the AIDS vaccine. "This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax's DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax's MVA vaccine at week 16 and again at week 24."

The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.

Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non- human primates for more than 3 1/2 years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax's vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.

More information will be released on the full dose trial when available later in 2007. GeoVax's AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV- 1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.

The human trials, utilizing GeoVax's AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, 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 the National Institute of Allergy and Infectious Diseases.