GeoVax

Corporate history

Formed in 2001 in Atlanta, Georgia, the approach used in HIV-1 vaccine development was originally based on preclinical work done by Dr. Harriet Robinson from 1992 to 2002. In 2002 laboratory space, equipment and personnel were acquired and work on an HIV-1 vaccine development plan began, and in May 2006 human clinical trials of the drug began.

GeoVax HIV-1 Vaccine

From preclinical results (using SHIV) 96% of primates (22/23) were protected from the virus over a three and a half year period when vaccinated, while by contrast five out of six primates died within eight months after being infected when left untreated. The vaccine works with a combined DNA vaccine and MVA (modified vaccinia Ankara) vaccine both of which lead to the insertion of genes into primate DNA which leads to foreign protein expression. With the GeoVax vaccine a variety of HIV proteins (both surface and internal) are expressed from genes which include the Env, Pol and Gag genes.

Therapeutic Vaccine Clinical Trials

During 2010, the AIDS Research Consortium of Atlanta (ARCA) began patient recruitment for a Phase 1 clinical trial sponsored by GeoVax Labs, Inc., investigating GeoVax’s DNA/MVA vaccine as a treatment for individuals already infected with HIV. The trial is primarily designed as a safety study, but will also collect and report data on the vaccine’s ability to elicit protective immune responses and control re-emergent virus during a pause in drug treatment. As part of the trial protocol, a volunteer must have begun drug treatment in the first year of infection and have achieved 6 months of stable viral control on drug treatment before entry into the trial and receipt of the first vaccination.

Preventative Vaccine Clinical Trials

GeoVax published results of Phase 1 safety and immunogenicity testing for its preventative vaccine trial on March 1, 2011. Based on published results, GeoVax will be advancing two regimens forward into the Phase 2a HVTN 205 trial. Regimens selected for advancement are the DDMM combination, which produced the highest T cell response rates, and the MMM combination. The MMM regimen produced the highest antibody-induced immune response.

The DDMM regimen consists of priming with two doses of the pGA2/JS7 recombinant DNA vaccine and boosting with two doses of VA/HIV62B recombinant MVA vaccine. The MMM regimen consists of priming and boosting with a total of three doses of the recombinant MVA vaccine.

HVTN 205 Study—In early 2009, the HVTN began enrolling patients in a preventative Phase 2 clinical trial sponsored by GeoVax Labs, Inc. This study is investigating a prime-boost approach using GeoVax’s combination DNA/MVA vaccine. During 2010, the study was expanded from 225 to 300 participants to include an arm gathering additional data on three MVA injections, without the use of the DNA component, which is an addition to the original arm testing two DNA priming and two MVA boosting injections. Preliminary results were announced by the company on December 9, 2010. Preliminary results indicate an excellent safety profile and highly reproducible immunogenicity subsequently confirmed by the official publication above in The Journal of Infectious Diseases.

Phase 2a Clinical Trial Expansion

In April 2011, GeoVax Labs, Inc. in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN) announced an expansion of the current Phase 2a clinical trial to include a new component. The new trial is HVTN 094 and will be conducted by the HIV Vaccine Trials Network. "Specifically, the HVTN plans to clinically test a novel vaccine product developed by GeoVax scientists that expresses human granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with inactivated HIV proteins. The novel vaccine consists of a recombinant DNA vaccine co-expressing human GM-CSF and non-infectious HIV virus-likeparticles. The DNA vaccine is used to prime immune responses that are subsequently boosted by vaccination with a recombinant modified vaccinia Ankara (MVA) vectored vaccine. The MVA expresses the HIV virus-like-particles, but does not express GM-CSF. The regimen builds on the GeoVax DNA/MVA vaccine that is currently in Phase 2a clinical testing through the HVTN."