The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), approved Novavax, Inc., an additional commitment of approximately $1.0 million to fund the third year of a 4 1/2 year research program.

Novavax is developing a novel HIV/AIDS virus-like particle (VLP) vaccine as part of an NIH Integrated Preclinical/Clinical AIDS Vaccine Development Program comprised of scientists from the University of Alabama at Birmingham, Emory University, and Harvard Medical School. All three institutions are working with Novavax in a collaboration to accelerate HIV/AIDS vaccine development.

Dr. Gale Smith, Vice President of Vaccine Development, explains, "We believe the only realistic solution to the global HIV/AIDS pandemic is an effective vaccine. Novavax is extremely pleased to be working with such an acknowledged group of world leaders in developing a novel HIV/AIDS vaccine. Our research is based on our insect cell technology for the production of recombinant virus particles that mimic HIV-1, but without the risk of infection."

According to Dr. Beatrice Hahn, one of the principal investigators at the University of Alabama at Birmingham, "Globally circulating strains of HIV-1 are extraordinarily variable, and this diversity poses a major obstacle to AIDS vaccine development. Currently, all candidate vaccines are derived from contemporary HIV-1 isolates, often selected solely based on availability. With VLP vaccines produced by Novavax, we are now testing whether consensus immunogens can elicit broadly cross-reactive immune responses and thus protect against a wide range HIV-1."

In the first two years of the program, Novavax developed a process to manufacture HIV-1 VLPs from consensus sequences of the HIV-1 envelope glycoprotein, the principle target for virus neutralization. These synthetic genes were shown to be incorporated into particles that are structurally similar to HIV-1. Scientists at UAB, Emory, and Harvard discovered that the novel HIV/AIDS VLP vaccines induced a range of immune responses and antibodies in small animals and non-human primates that neutralized both laboratory strains and acute, contemporary HIV-1 isolates. The objectives for the team during 2006 are to maximize efficiency of incorporation of the HIV-1 envelope glycoprotein into particles. Novavax then plans to begin preparations for human clinical trials of an improved HIV/AIDS VLP vaccine.

Novavax's virus-like particle (VLP) vaccines use recombinant DNA technology to produce antigenic structures that mimic a virus to produce a protective immune response without the risk of infection or disease. Viral proteins can self-assemble into VLPs when over-expressed in certain cells. The use of VLP technology has already been proven with the success of the hepatitis B vaccine and more recently with developmental human papillomavirus vaccines. This is the first time that VLP technology has been applied to create a potential HIV/AIDS vaccine and is the same technology Novavax is using to produce influenza VLP vaccines that are readily adaptable and could be scaled up to meet a surge in demand during a pandemic, stated the release.