By Sean Meyer/London Community News/Twitter: Newswriter22
A working HIV vaccine could be saving lives in just five years time based on the preliminary results shared by researchers at Western University
The first and only preventative HIV vaccine, based on genetically modified killed whole-virus has been “making steady progress” according to Dr. Chil-Yong Kang, who spoke with media on Tuesday (Nov. 6), at Western’s Siebens Drake Research Institute. Kang, along with Dr. Dong Joon Kim, spokesperson for Sumagen Co. Ltd., said the vaccine being developed by his team at the Schulich School of Medicine and Dentistry “holds tremendous promise for success.”
Kang said the results showed “absolutely no adverse effects, except for some minor and minimal muscular and joint pain at the point of injection.” That result, Kang said, can be expected with any injection.
The announcement today that 24 patient enrollment has progressed smoothly and with no adverse effects observed — including local reactions, signs/symptoms and laboratory toxicities — proves the vaccine offers “safety and tolerability in humans” and opens the door to beginning phase two in approximately a year’s time.
“We don’t anticipate any problems because our results show very clean and clear results,” Kang said. “It takes about a year for phase two clinical trials. The phase three takes about three years, you have to vaccinate and wait for the natural infections. (A working vaccine could be developed) in five year’s time.”
Kang received government approval for the study on the vaccine on Dec. 16, 2011, with clinical trials starting in March with 24 HIV-infected men and women between ages 18 and 50.
The phase one clinical trials study the adverse effect of the vaccine in the human body. Not only were there no adverse effects, but also rather Kang said there was a 32-fold increase in antibodies working against HIV.
The interim data showed significant increases in the HIV-1 antibody formations after the vaccine was introduced, compared to the base line in some patients. Even though this study is a blinded until completion, Kang said these results are encouraging for the potency of the vaccine.
With these interim results, Kim said Sumagen is confident of the safety of the vaccine and the potency of inducing immune responses in human trials.
“We found the virus 30 years ago, 1983. During 30 years, our humankind and the big pharmaceutical companies tried to develop a preventative HIV vaccine. But until now, none had been successful,” Kim said. “Theoretically, we expect our vaccine can prevent HIV/AIDS. It should be safe and it should succeed in inducing the immune responses from the human body. Today’s result is what we expected. It is good news.”
HIV/AIDS has killed more than 28 million people worldwide and more than 34 million people currently live with the virus infection. Other HIV vaccines evaluated through human clinical trials have focused on specific components of HIV. Kang’s vaccine — identified as SAV001-H — uses a killed whole HIV virus, much like the killed whole virus vaccines for polio, influenza, rabies and hepatitis A.
The HIV is genetically engineered so it is non-pathogenic and can be produced in large quantities.
Kim explained Sumagen has invested $60 million in the project to-date and is expecting to spend another $30-$40 million on the phase two of the project. In order to complete phase three, Kim said the cost could be another $100 million.
While Kim said Sumagen is excited about what developing the vaccine could mean in both terms of both humankind and company commercialization, Kang focused on what it would mean to him personally.
“My personal motivation is I’m a virologist; I like to save lives. That is my strongest motivation,” Kang said. “Edward Jenner developed the vaccine against small pox and he saved millions and millions of lives over the years. If we can eradicate HIV or prevent HIV infection, that will be the happiest achievement I could accomplish.”
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