Bionor Immuno initiates Phase IIb HIV vaccine trial

This randomized, double-blind, placebo-controlled trial is being conducted in HIV infected patients with the potential to offer an important drug free break in their current antiretroviral therapy. The company anticipates that trial results will be available by year end 2009.

According to the company, earlier observations of HIV patients showed that sustained immune responses to the protein p24 in the HIV virus were associated with delayed disease progression. Building on this observation, Vacc-4x is comprised of four modified synthetic peptides, each of which correspond to a conserved domain of the p24 protein.

The modified peptides in Vacc-4x are said to be designed to amplify and extend immunity to this protein, which could allow for extended drug free periods and may delay disease progression.

Richard Pollard, head of the infectious diseases division at The University of California, Davis Medical School, Sacramento, California, said: “This is the largest current therapeutic vaccine trial in the world involving 345 patients. This trial will establish a solid foundation for HIV immune therapies if we can maintain immunogenicity during drug free periods.”