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News: HIV vaccine FIVE years away?! Passed first human trials!
Member Since: 1/6/2012
Posts: 12,011
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HIV vaccine FIVE years away?! Passed first human trials!
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Canadian scientists testing a preventative HIV vaccine announced on Tuesday that they have cleared a major hurdle, saying initial results from human clinical trials show no adverse effects.
Developed by researchers at the University of Western Ontario, the first and only preventative HIV vaccine based on a genetically modified killed whole-virus, has shown promising results after Phase 1 trials.
“These are very exciting results,” said Dr. Chil-Yong Kang, professor of virology at the university’s Schulich School of Medicine and Dentistry. “It is, really, a major milestone.”
Last year, the vaccine, called SAV001-H, was approved by the United States Food and Drug Administration to begin human clinical trials. It’s the only HIV vaccine currently being developed in Canada.
Kang’s vaccine is unique in that it uses a killed whole HIV-1 virus to activate the immune response — a strategy that has been used before to develop successful vaccines for influenza, polio, rabies and hepatitis A.
The human immunodeficiency virus used in the vaccine has been genetically altered to render it nonpathogenic, or unable to cause disease. Kang and his research team further inactivated the virus using chemicals and radiation.
Because this strategy has been successful for other viral diseases, there is hope that this vaccine will work, said Kang, adding, “Surprisingly, no one used our strategy before.”
As part of Phase 1, which began in March, 24 healthy men and women with HIV were selected to participate at two Los Angeles hospitals. The initial part of the study was designed to evaluate how safe and tolerable the vaccine was.
Participants, aged 18 to 50, were randomized into two treatment groups and recieved the vaccine or a placebo. (Eighteen people were given the vaccine and six were given a placebo.)
“There were no adverse effects,” said Kang.
Participants have undergone monthly checkups and to date, there have been no local reactions, or symptoms since the SAV001-H injection. The biggest complaint was a sore arm — but that only lasted a day and is expected with any injection, said Kang.
“And after the vaccination, the level of (HIV-1) antibodies increased significantly. That means our vaccine is working to stimulate the immune responses.”
“Phase 1 was the biggest hurdle,” said Kang, adding this success paves the way for upcoming clinical trials.
Phase 2, set to begin next year, will be tested on about 600 HIV-negative volunteers at high risk for HIV infection. Researchers will measure their immune response to the vaccine.
The CIHR Canadian HIV Trials Network (CTN), which facilitates HIV clinical trials of the highest scientific and ethical standards, will test the vaccine during Phase 2, said Kang.
The second phase will take about a year and if all runs smoothly, researchers will advance to the final phase.
Phase 3 will enrol about 6,000 HIV-negative volunteers at high risk for the disease. Half the participants would be vaccinated and half unvaccinated. They will be tracked for three years to see how many in each group became infected with HIV.
The second and third phase of testing will be carried out in Canada, the United States and in various European countries.
“In order to make enough volunteers available for the vaccination I think we need to have this trial available in many different countries,” said Kang.
If the vaccine proves effective and “everything goes well,” it could be on the market in about five years, he said. It would be given to high-risk groups such as sex workers, men who have sex with men, injection drug users and hemophiliacs, he said.
To date, HIV/AIDS has killed more than 28 million people worldwide, and more than 34 million people currently live with the infection.
Kang began studying HIV in 1987 and has been working with his team on developing the vaccine for about a decade.
Kang and his research team received funding from Sumagen Canada, a company that was created in 2008 to support the development of the vaccine. It’s a subsidiary of Sumagen Co. Ltd., a Korean-based pharmaceutical venture company.
There are about two dozen other HIV vaccines being tried worldwide.
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http://www.thestar.com/living/health...say-developers
Quote:
HIV vaccine possibly five years away
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.
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http://www.londoncommunitynews.com/2...ve-years-away/
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Banned
Member Since: 6/12/2012
Posts: 6,002
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YAASSSS I just read this earlier.
Were getting closer 
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Member Since: 1/2/2012
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Banned
Member Since: 5/1/2012
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this is what we call progress people
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Member Since: 3/29/2011
Posts: 758
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eh i'd prefer if they cured cancer
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Member Since: 1/3/2010
Posts: 21,098
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Is it too early to be happy? 
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Member Since: 1/2/2011
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Member Since: 5/28/2010
Posts: 29,225
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Quote:
Originally posted by ThePatrickk
eh i'd prefer if they cured cancer
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Member Since: 8/7/2010
Posts: 4,179
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Quote:
Originally posted by ThePatrickk
eh i'd prefer if they cured cancer
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How about both.
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Member Since: 2/18/2012
Posts: 25,853
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Quote:
Originally posted by ThePatrickk
eh i'd prefer if they cured cancer
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It doesn't matter, both are horrible diseases that take lives.
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This is amazing progress
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Member Since: 9/22/2011
Posts: 9,178
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This is amazing news! I hope it works out, we need this breakthrough.
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Member Since: 11/27/2011
Posts: 15,434
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Amazing!
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Member Since: 3/3/2012
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Quote:
Originally posted by ThePatrickk
eh i'd prefer if they cured cancer
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Yeah... because it is as easy as deciding which they would like to cure first 
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Member Since: 12/2/2011
Posts: 52,765
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making progress
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Member Since: 5/8/2012
Posts: 15,801
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nice 
Quote:
Originally posted by ThePatrickk
eh i'd prefer if they cured cancer
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wat
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Member Since: 4/21/2011
Posts: 10,659
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Read this this morning. Fantastic news.
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Member Since: 10/1/2011
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Member Since: 8/29/2011
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Yes
Hopefully we can spread it to poor countries if and when we get it. 
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Member Since: 6/18/2012
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Banned
Member Since: 12/29/2002
Posts: 19,803
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Not to be pessimistic, but Phase 1 is nothing to get excited about. Several clinical trials have failed in Phase 2 or Phase 3, so I'll wait a bit more to be optimistic 
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