TECHNOLOGY & PRODUCTS

Human Clinical Trials

Preventative Human Clinical Trials

Human clinical trials for the preventative use of the GeoVax HIV/AIDS vaccine have been conducted by the HIV Vaccine trials Network (HVTN). The HVTN, funded and supported by the U.S. National Insitute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of HIV/AIDS vaccines.

Completed – Phase 1 Human Clinical Trial (HVTN 045)

A phase 1 human safety trial primarily to test the safety of the GeoVax DNA vaccine was approved by the Food and Drug Administration (FDA) and initiated in early 2003. Conducted at three (3) sites in the USA by the HVTN, this phase 1 trial concluded in late 2004 and successfully demonstrated the safety of GeoVax's AIDS vaccine.

Completed – Phase 1a/1b Human Clinical Trials (HVTN 065)

Human trials testing the GeoVax DNA and MVA vaccines as a prime-boost regimen started at five sites in the United States in April 2006. The first trial tested 1/10th doses (low dose) of the DNA and MVA vaccines for safety and immune responses. Once the 1/10th dose was proven safe, a second trial was initiated to test safety of the full dose of the GeoVax DNA and MVA vaccines. Both trials used two DNA primes at weeks 0 and 8, and two MVA boosts delivered at weeks 16 and 24. A third trial tested a single DNA prime at week 0 followed by MVA boosts at weeks 8 and 24. A fourth trial tested priming and boosting with MVA alone, with the MVA delivered at week 0, 8 and 24. Trials 3 and 4 used full doses of the vaccines.

Highlights of these trials included:

  • GeoVax vaccines were well tolerated with no or mild, local and systemic reactions in the majority of trial participants.
  • 80 percent of both low and full dose trial participants responded to the vaccine which stimulated anti-HIV T cell (white blood cells) and antibody responses.
  • More volunteers had antibody responses to the full dose than to the low dose vaccine, whereas response rates for T cells were similar for the doses of the vaccine.
  • Two DNA primes were more effective than one or no DNA prime at eliciting T cell responses.
  • The 2nd MVA vaccination positively increased CD8 T cell and antibody responses.

The excellent safety and immunogenicity results of HVTN 065 formed the basis for the GeoVax AIDS vaccine progressing to phase 2a trials through the HVTN. Of the more than 80 protocols sponsored by the HVTN, only 5 have progressed to phase 2. GeoVax is extremely pleased its vaccine has merited progression to phase 2.

Ongoing – Phase 2a Human Clinical Trial (HVTN 205)

The HVTN-sponsored GeoVax phase 2a trial started in early 2009 and will include 225 participants, 150 vaccine recipients and 75 receiving placebos. Participants will be enrolled at 13 sites in North America and two sites in South America. The trial regimen is using two doses of DNA, administered at week 0 and the second at week eight, and two doses of MVA, administered at week 16 and the second at week 24. The goal of the trial is to provide additional safety and immunogenicity data to support a phase 2b "Proof of Concept" study.

Therapeutic Human Clinical Trials

Currently, therapeutic trials are being planned by GeoVax to determine the vaccines' ability to supplant the need for continuing drug treatment in infected people currently on drug therapy. The first therapeutic trial under consideration is an open label phase 1 clinical trial in infected individuals who started drug treatment within the first year of infection. GeoVax will support this trial whose targeted start date is late 2009.