Bionor Pharma has recently concluded a stage 2b trial of the therapeutic vaccine Vacc-4x. Dr. Jan van Lugen of the University Medical Centre Hamburg-Eppendorf in Germany led the trial and announced the results at the AIDS Vaccine 2011 Conference in Bangkok. Initially the trial was considered a failure because the vaccine did not increase the levels of white blood cells in trial participants.
However, a later follow up with the trial participants revealed that participants who received the vaccine had significantly lower virus loads (up to 70% decrease), and approximately a third of the participants who received the vaccine were off antiretroviral therapy for over a year after receiving the vaccine. The study consisted of 135 HIV positive adults on antiretroviral therapy, two thirds of which received the vaccine and one third of which received the placebo. Participants were given the vaccine a total of six times.
A new trial will be starting in Germany in 2012 which will combine Vacc-4x with Revlimid (lenalidomide). Revlimid is currently used to treat multiple myeloma, and has been shown to induce immune response and reduce inflammation. It is hoped that the combination will increase the effectiveness of the vaccine.
Vacc-4x includes protein fragments similar to those found in HIV. Bionor believes that these fragments will create a heightened immune response in HIV/AIDS patients, increasing their ability to control the infection. For more information, see the press release on the Bionor Pharma website.