GeoVax Labs, Inc., a biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, has completed enrollment in a nine-patient phase I/II clinical trial testing the safety, immunogenicity and ability of its DNA/MVA vaccine to elicit protective immune responses in HIV-infected individuals. The primary goal of this study is to document the safety and immunogenicity of GeoVax’s vaccine in HIVpositive patients with well-controlled infections using oral HIV drug medication.

Following vaccination, the trial includes a short period of drug-interruption to evaluate the ability of the vaccine to control the infection in the absence of continuing drug therapy. The phase I/II trial (designated GV-TH-01) consists of priming with a recombinant DNA vaccine followed by boosting with a recombinant modified vaccinia Ankara (MVA) vaccine.

The vaccine regimen elicits both antiviral antibody that can block infection and antiviral T cells that can recognise and kill infected cells. The trial is being conducted at the AIDS Research Consortium of Atlanta, the Alabama Vaccine Research Center at the University of Alabama, Birmingham and the AIDS Research Alliance of Los Angeles.

Robert McNally, Ph.D., president and CEO of GeoVax, stated, “This pilot study is our first trial investigating use of a therapeutic vaccine to address the need for a treatment that is better tolerated and less costly than the HIV oral medications currently available. We anticipate having meaningful data from the programme later this year.”

Harriet Robinson, GeoVax’s chief scientific officer, said, “Our next step planned for our therapeutic vaccine development programme is a phase I clinical trial to investigate the use of our vaccine in combination with standard-of-care drug therapy in young adults. This trial will likely be conducted by the International Maternal Paediatric Adolescent AIDS Clinical Trial Group (IMPAACT). One of the hopes for therapeutic vaccination is that combining a vaccine with drugs will allow the eradication of virus from an infected individual. Drugs primarily prevent infection whereas a vaccine can both block infection and kill infected cells.”

HIV infection, which can lead to AIDS, is a pandemic that can affect anyone, regardless of race, gender, age, or sexual orientation. 33 million people are currently infected globally. Since the beginning of the  epidemic, more than a million people in the US have contracted the virus. Every 9 1/2 minutes, someone in the U.S. is infected with HIV. Globally, HIV is the top killer among women of reproductive age. 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. GeoVax vaccines are currently designed to function against clade B.