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Over the course of Phase I, patients have not experienced negative effects while taking SAV001-H

The first HIV vaccine for prevention has had a successful Phase I Clinical Trials in the United States, and is preparing to move on to Phase II and Phase III. 

The preventative HIV vaccine (called SAV001-H) was developed by Dr. Chil-Yong Kang and a team of researchers at the University of Western Ontario's Schulich School of Medicine & Dentistry as well as researchers from Sumagen Co. Ltd. Unlike other HIV vaccines that underwent clinical trials, SAV001-H contains a killed whole HIV-1 rather than just one specific part of HIV as an antigen or genetic vaccine using recombinant DNA. 

Phase I of clinical trials for the first HIV preventative vaccine started in March 2012. Infected men and women ranging from 18-50 years of age were separated into two groups, where one received SAV001-H and the other a placebo. 

Over the course of Phase I, patients have not experienced negative effects while taking SAV001-H. This includes signs/symptoms, laboratory toxicities and local reactions. 

"We have proven that there is no safety concern of SAV001-H in human administration and we are now prepared to take the next steps towards Phase II and Phase III clinical trials," said Dr. Dong Joon Kim, spokesperson for Sumagen. "We are delighted to be one step closer to the first commercialized HIV vaccine."

Also, interim data showed a large increase in HIV-1 antibody formations after SAV001-H was given to patients. 

The humoral immune responses still need to be analyzed, but these initial results are promising. This could make SAV001-H the first commercially available HIV prevention vaccine in the United States at some point. 

There has been great progress for preventative HIV drugs in the U.S. lately. Back in July, the U.S. Food and Drug Administration (FDA) approved the HIV prevention pill called "Truvada." 

Source: University of Western Ontario

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RE: lonnnnng way still
By kingmotley on 11/8/2012 4:38:22 AM , Rating: 2
If I am not mistaken (and I could be), there are certain things that can get onto a "fast track" FDA approval process that bypasses a number of the time consuming things needed. HIV cures/immunizations are one of those because of the sheer number of fatalities involved simply outweigh the possibility that you may get headaches in 20 years because of it, etc.

RE: lonnnnng way still
By MozeeToby on 11/8/2012 11:33:31 AM , Rating: 2
The fast track process has a lot to do if whether or not there are other effective treatments available. How things would balance out in this case... I'm not sure. On the one hand, the "sheer number of fatalities" from HIV/AIDS in the US is high, but not insanely so. Ten thousand people dying a year is obviously bad, but an unproven vaccine could cause much more damage, even if it's only flaw is not being effective you could see a rise in cases if it changes people's perceptions enough. But of course, this is a preventative vaccine, not a therapeutic one. I've not seen anyone saying that this will cure HIV, the idea of allowing 10's of thousands of people to get infected with a fatal disease while we wait for approval is not going to be an easy pill to swallow.

I think the real problem that a lot of people just don't realize is how hard it is going to be to actually get a vaccine to the people who need it. And I'm not even talking about places like Sub-Sahara Africa, I'm talking about poor neighborhoods on the coasts. Generally, the people who die from AIDs in the US are those who cannot afford treatment (incidentally, those are the same people who knowingly or unknowingly keep the disease spreading). Those are, again, the same people who are least likely to sign up for a vaccine; especially one that is relatively unproven.

You also have to remember that the subject is rife with conspiracy theories: at various times people have accused the US government of creating the virus (as if we have the knowledge and technology to create something as complex as HIV now, let alone 4 decades ago) to kill off blacks and/or homosexuals. And it sounds ridiculous, until you hear about things like the Tuskagee and Guatemala studies and the paranoia is more understandable.

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