AlphaVax, a North Carolina-based vaccine company, presented an analysis of blinded results recently at the AIDS Vaccine 2006 meeting in Amsterdam from a phase 1 clinical trial, run in collaboration with the Division of AIDS (DAIDS) at the National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN), evaluating a prototype HIV vaccine incorporating the HIV gag gene made using the company's alphavaccine technology.
Preliminary analysis of the blinded data, making an assumption that the placebo recipients generated no immune response, suggests that the vaccine induced an antibody response to the HIV gag antigen in 100 per cent of the recipients at the highest dose tested and in a majority of the recipients at a 10-fold lower dose. In addition, the vaccine was well tolerated and no vaccine-related safety issues were identified in the clinical trial.
"While definitive conclusions must await completion and unblinding of the study, we are very encouraged by the immunogenicity and safety profile of this candidate vaccine," said Jeff Chulay, MD, AlphaVax's chief medical officer. "Our alphavaccine platform has been proven extensively in preclinical models and we are pleased that these data are beginning to be confirmed in humans." AlphaVax is working with its partners to advance a second-generation multigene HIV vaccine into clinical trials, as well as alphavaccines against influenza, cytomegalovirus (CMV) and other important diseases. "These results demonstrate the potential of our vaccine platform," commented Peter Young, AlphaVax president and CEO, "and we are excited about harnessing this potential in products against not only HIV but many other significant threats to public health."