Inching closer to a cure for AIDS

According to the HIV Vaccine Trial Network, after an experimental vaccine
has been tested in laboratory and animal studies to determine its safety and
immune response, it must successfully complete three stages of testing in
people before it can be licensed.

 

The Phase l clinical trials, if approved, will double-check the safety of the vaccine using HIV positive volunteers. The second stage – Phase ll trials – would then assess the immunogenicity of the vaccine.

 

Human trials are necessary to test the efficacy of the vaccine in protecting against HIV infection because the HIV virus does not cause AIDS-like symptoms in animals, says Kang. However, the immune responses in the animal trials have been promising, he says.

 

Since the AIDS virus was recognized in 1983, there have been numerous trials through pharmaceutical companies to develop vaccines; however, no commercialized vaccine has been developed to date.

 

If the vaccine is given the go-ahead to enter into human clinical trials, it will be at least four years before Kang expects to have statistically significant analysis, and possibly allow the vaccine to be marketed.

 

Through Western, Sumagen Canada has secured patents for the vaccine in over 70 countries in the world, including the United States, the European Union and South Korea. According to the firm, the animal testing has resulted in good antibody reactions in immunology tests, with no adverse effects or safety risks.

 

Sumagen says it is prepared to begin the clinical trial in the U.S. immediately following FDA approval.

 

Kang’s vaccine uses a killed whole HIV-1, much like Jonas Salk’s killed whole polio virus vaccine. The HIV-1 is genetically engineered so that it is non-pathogenic and can be safely injected, and can be produced in large quantities. The idea is the vaccine would prime T-cells to destroy cells harboring HIV, essentially curing a patient of the virus.

 

“In HIV there are at least six major sub-types, so you have to make a vaccine against each and every sub-type in order to have a really effective vaccine,” says Kang. “If this virus vaccine works, then we can use the same strategy to customize the vaccine against different viruses in different regions in the world.”

 

Kang’s vaccine has been manufactured at a bio-safety level 3 (BSL3) good manufacturing practice (GMP) facility in the United States.

 

That may soon change, as London, and Western, are currently one of four organizations on a short list of Canadian cities under consideration by the federal government to build Canada’s first HIV vaccine manufacturing facility.

 

Part of the funding for the secure, ultra high-tech $88-million HIV vaccine manufacturing facility will come from the Bill and Melinda Gates Foundation.

 

Kang is hopeful London and Western’s bid will be successful, as having a facility closer to home will help his research. It would also be more convenient.

“When we were looking for facilities like this to manufacture our vaccine we
could find only a few around the world,” he says. “This kind of facility near us
would help us to manufacture our candidate vaccine and also future vaccines.”

“This is exhilarating and promising news for London,” says Ted Hewitt,
Vice-President (Research and International Relations) at Western.

“We have our work cut out for us, as I am sure the competition will
be tough, but London and Western have a great history of research and
manufacturing success. This is exemplified by the leading research of
Dr. Yong Kang in developing an HIV/AIDS vaccine.”

Mayor Anne Marie DeCicco-Best was hopeful Western and London will
have a larger role in curbing the scourge of HIV/AIDS.

“HIV/AIDS has taken more than 25 million lives and today 35 million people
are living with HIV,” she says. “London now has an opportunity to show that we
can play a key role in saving lives around the world. We are ready.”

Western and other contenders have submitted a full proposal for the facility,
with a decision possibly by year’s end.

For Kang, each milestone reached brings his research one step closer to
fruition, and the possibility of saving millions of lives.

“We have been working on this project for over 20 years,” says Kang.

“It has been a long, painful process, but we have gotten to this stage now, to
test our vaccine, and see whether or not it can prevent HIV infections. Despite
the tremendous amount of scientists working on this project, to date there has
not been an effective vaccine.”

Kang and his team have invested years getting to this point; even so,
they are not alone in having created a vaccine that could potentially curb the
deadly toll of this virus.

“At the moment the wisdom of mankind is struggling with this challenge,”
says Kang.

According to the HIV Vaccine Trial Network, there are 13 ongoing clinical
trials, each representing years of work and countless dead ends, each approaching
the potential solution in a different way, and each representing hope.

“Over the 20-year period there has been some ups and downs because
of the failure of some of the well-known trials. However our strategy is not
the same as the others, so in some way we are encouraged to see whether our
vaccine strategy will work better,” says Kang.

Hewitt says after a long and intensive process, the fact Kang has been
issued one of only a very few HIV vaccine patents in the world, is testament
to his outstanding years of research at Western.

The application for the approval of Phase 1 human clinical trials is a very
important milestone for our vaccine development... we hope this vaccine is it,
and hopefully this vaccine will prevent HIV infection and save millions of lives.

 

“He has developed the technology to take it this far in a process where dozens of other potential vaccines, from much larger institutions globally, have failed,” says Hewitt. “We are tremendously proud of Dr. Kang’s accomplishments to this point.”

 

Kang says while he sees the trials of fellowscientists worldwide fail, which he admits can be discouraging, he is confident his approach to the vaccine is a step others have not taken.

 

“It has been a tremendous effort to engineer or design a vaccine,” says Kang, adding “this type of research and development is so important for humankind to saving millions of lives.

 

“The success of this vaccine will really help the millions and millions of people around the world affected by HIV/AIDS. We can save lives.”