Preventive vaccine against HIV/AIDS to be tested on patients soon: GeoVax Labs
GeoVax Labs, Inc will soon begin clinical studies of its preventive vaccine against HIV infection.
GeoVax’s unique two component vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara (MVA), is designed to stimulate both anti-HIV T cell and anti-HIV antibody immune responses.
Stimulation of both T cells and antibodies differentiates the GeoVax vaccine from many other vaccine candidates. GeoVax’s DNA and MVA vaccines are used in a prime-boost protocol in which priming is done with the DNA and boosting with the MVA.
Both the DNA and MVA express the three major proteins of the AIDS virus: Gag, Pol, and Env, and produce non-infectious virus-like-particles. These particles contain proteins that mimic more than half of the components of the AIDS virus, but cannot cause AIDS.
This multi-protein approach is designed to elicit a broad multi-target protective T cell response. The Env protein is designed to elicit a protective antibody response against the natural form of the virus envelope glycoprotein as well as protective T cells.
The Phase 2a preventative trial using the preventive vaccine against HIV has started enrolling patients at the last 2 of its 13 sites.
GeoVax Labs is now enrolling patients at two locations in Peru for Phase 2a trial, the company said.
“We have engaged a full-service Clinical Research Organization (CRO) to support our therapeutic human clinical vaccine trials. They will be providing assistance for clinical trial management; clinical, medical and safety monitoring; data management, biostatistics and medical writing services,” stated Robert McNally, Ph.D., president and chief executive officer, GeoVax.
The preventative trial, designated as HVTN 205, is being conducted by the HIV Vaccine Trials Network (HVTN).
The HVTN, funded and supported by the National Institutes of Allergy and Infectious Diseases (NIAID), is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines.
The HVTN has sponsored over 80 Phase 1 trials for the initial evaluation of safety and immunogenicity of candidate HIV/AIDS vaccines. The results of these trials have merited only five Phase 2 trials.
GeoVax is currently preparing an Investigational New Drug application (IND) for its Phase 1 therapeutic trial for US FDA.
This initial trial will be conducted in Atlanta and enroll individuals who began successful antiretroviral therapy within the first year of infection.
The goal of this trial is to determine the safety and immunogenicity of the vaccine in patients with well-controlled infections who started on antiretroviral therapy drugs within six months of testing positive for HIV.
“Based on the success of the simian prototype of the GeoVax vaccine in controlling established infections in the non-human primate model, we believe our vaccine should be effective in at least some infected humans,” said Dr. Harriet Robinson, Chief Scientific Officer and a developer of the vaccine.
Studies on the therapeutic potential of the simian prototype for the GeoVax vaccine have been conducted in Dr. Rama Rao Amara’s laboratory at the Emory Vaccine Center and the Yerkes National Primate Research Center.
These studies showed the vaccine achieving 100-fold reductions in viral RNA in infected non-human primates placed on drugs within four to five months of infection, then vaccinated while on drugs, and, once the vaccine response was in place, released from drugs.
GeoVax has completed a Pre-IND meeting with the U.S. FDA in December and are well into the process for submission of an IND for a Phase 1 trial.
HIV is a worldwide disease with different subtypes (or clades) of the virus predominating in different regions of the world. Clade B is the predominant subtype in North America. Globally, most infections involve subtypes AG, B, and C.
33 million people are currently infected globally and it is estimated that there will be 2.5 million new infections this year.
Since the beginning of the epidemic, over a million people in the U.S. have contracted the virus. Every 9 1/2 minutes, someone in the U.S. is infected with AIDS.
Globally, HIV is the top killer among women of reproductive age.
In 2008, antiretroviral treatment in low and middle income countries was restricted to about 3 million people.
In the United States, about 50% of those who are infected are estimated to be on drug treatment.
HIV infects 60,000 new new people annually in the United States alone. Antiretroviral drugs, which have to be taken for life, have side effects and are expensive, costing on average $18,000 per year.
GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents.
GeoVax’s AIDS vaccine technology is the subject of 20 issued or filed patent applications.
GeoVax AIDS vaccines are designed for use in uninfected people to prevent acquisition of HIV-1 and limit the progression to AIDS should a person become infected.
GeoVax’s core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Chief Scientific Officer, through a collaboration of colleagues at Emory University’s Vaccine Center, the National Institutes of Health (NIH), The Centers for Disease Control and Prevention (CDC) and GeoVax.
HIV Vaccine Trials Network (HVTN) is based in Seattle, Washington.
Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided additional support to GeoVax AIDS vaccine development program with a $18 million IPCAVD grant awarded in late 2007.