Dec 212011

The first of its kind in terms of using a killed whole virus approach

Due to ongoing research at the University of Western Ontario, in five years, kids might be able to receive a HIV/AIDS vaccine as they would a mumps or measles shot.

Researchers from Western were joined by local representatives from all levels of government, along with Sumagen Canada, at the university on Tuesday (Dec. 20) to announce the launch of the FDA-approved human clinical trials of the first preventative HIV vaccine based on a genetically modified “killed whole virus.”

“The preventative vaccine is to make people immunized and those antibodies can prevent the infection of HIV,” said Dr. Chil-Yong Kang, a virologist at Western. “It’s actually safe and we are confident this vaccine will be safe and will induce immune responses in humans.”

This is also the only HIV vaccine under development in Canada and the first of its kind in terms of using a killed whole virus approach.

Kang and his team at Western, with support of Sumagen Canada, a South Korea pharmaceutical company, developed the vaccine. The SAV001 vaccine has been proven to stimulate strong immune responses in preliminary toxicology tests with no adverse effects or safety risks.

More than 28 million people around the world with HIV/AIDS have died from complications of the virus since it was diagnosed in the early-1980s. Currently there are 35 million people who currently live with the infection. Kang said the team at Western has been working on a vaccine for around a decade.

There were three failed human trials happened from 2003-2009 that focused on different approaches to developing a vaccine. The first looked at specific components of HIV as an antigen (a molecule that’s foreign to the body), the second looked at a genetic vaccine using recombinant (or artificially formed) DNA, and the third looked at an artificial virus carrying HIV genes.

But, Kang said he and his team took a different approach to the problem.

“We did not use the other strategies others have,” Kang said. “This is the first time we developed a vaccine using the killed whole virus strategy.”

Similar to the killed whole virus vaccines for polio, influenza, rabies and hepatitis A, where a dead virus is introduced to the body to spark immune system responses, this genetically engineered virus, called HIV-1, is non-pathogenic, meaning it can’t cause the disease.

But before the vaccine can be commercialized, it must go through three phases of human clinical trials.

The first phase, involving 40 HIV-positive volunteers, is set to begin next month and will focus on the vaccine’s safety. The second phase, involving 600 HIV-negative volunteers who are in the high-risk category for HIV infection, will measure immune responses. The third phase, 6,000 HIV negative volunteers who are also in the high-risk category for HIV infection, will measure the efficiency of the vaccine compared to a non-vaccinated group.

The first two phases should take around a year each. The final step should take around three years.

“If it is safe and effective and certainly people can receive this vaccine,” Kang said. “For the phase one and phase two clinical trials, we are very confident. But Phase three, god only knows, we’ll see.”

The vaccine will be produced in Maryland and Colorado. Western President Amit Chakam said those locations were picked because there isn’t the capacity in Canada to produce the vaccine.

“If we had that capacity here … I’m pretty sure they would have considered that as a possibility,” Chakam told reporters after the announcement, adding while there’s a less entrepreneurial-focused pharmaceutical business environment in Canada, the results of the trial could help spark that type of a climate, not to mention the benefit for the university.

“If it is successful, it’ll be a jackpot for Western in terms of claiming our stage in the world as an institution that does something important,” he said. “Sometimes you need those jackpots to raise your profile.”

Dr. Dong Joon Kim, a Sumagen representative, said the company has been supporting this project since 2005.

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