backtop


Print 22 comment(s) - last by JonnyDough.. on Nov 10 at 2:42 PM


  (Source: topnews.in)
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



Comments     Threshold


This article is over a month old, voting and posting comments is disabled

Volunteers wanted!
By heerohawwah on 11/7/2012 10:44:28 PM , Rating: 1
Is it just me or am I the only one who thinks it might be best NOT to put this vaccine to the test after being immunized? Group org...parties all around...
yikes.




RE: Volunteers wanted!
By inperfectdarkness on 11/8/2012 2:12:28 AM , Rating: 2
They are probably going to test largely in Africa. No offense to anyone reading this--Africa has the world's largest HIV-positive population. Finding test subjects who will potentially be exposed to HIV in the near future is going to be much easier there.


RE: Volunteers wanted!
By inperfectdarkness on 11/8/2012 2:15:34 AM , Rating: 2
Exempting So-Cal's thousands of porn stars, of course.


RE: Volunteers wanted!
By fishman on 11/8/2012 6:59:22 AM , Rating: 5
Actually, the rate of AIDS infection in the porn industry is very, very low.


RE: Volunteers wanted!
By kattanna on 11/8/2012 11:10:54 AM , Rating: 2
quote:
They are probably going to test largely in Africa.


and hopefully.. when they do get a viable vaccine, it will also be one of the first places to be widely deployed..freely.

I could actually see it as something the gates foundation would pick up the bill for.


RE: Volunteers wanted!
By Master Kenobi (blog) on 11/8/2012 6:06:26 PM , Rating: 1
There's a good chance of it. Gates won't jump on it unless the data looks good. He's a skeptic and for good reason.


RE: Volunteers wanted!
By JonnyDough on 11/10/2012 2:42:28 PM , Rating: 2
The really beautiful thing about research is that you could start a company in Africa with the data, without transporting the actual virus there. If the FDA drags their feet, it could easily become a patent in some other country first. This happens all the time.


lonnnnng way still
By excrucio on 11/8/2012 12:21:22 AM , Rating: 2
This was on reddit few days ago. It will be another 7-10 years before we see it on the market, if it gets all the way through. long process. but one can hope for the future




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.


Virus Myth
By Myrandex on 11/8/2012 2:44:08 PM , Rating: 2
Check out Wrongful Death and Are You Positive? both by Davis. These fictional works are quite interesting and are on this topic. They are free ebooks available from both amazon and Barnes and noble. There is scientific facts in these books though and it really can open your mind about AIDs. After reading them I'm not exactly ready to go looking for someone who is considered to have aids to test out theories mentioned in the books, but they are a good read and I would recommend it to anyone.

Jason




mmm...
By Macuser89 on 11/7/12, Rating: 0
I Already Have My HIV Prevention Vaccine
By Arsynic on 11/8/12, Rating: -1
By MozeeToby on 11/8/2012 11:15:35 AM , Rating: 2
44% of people with HIV don't know they have it. Some 10% percent of people with HIV have it at levels that can't be detected by standard tests. So, what you're really saying is "don't have sex" which, while effective, is quite boring and not advice that will be realistically followed by the majority of the population.


By xti on 11/8/2012 11:55:56 AM , Rating: 2
1. meet someone at the bar...
2. take them home
3. Q: do you have aids?
4. Return to said bar unsatisfied
5. See #1


RE: I Already Have My HIV Prevention Vaccine
By leviathan05 on 11/8/2012 12:20:12 PM , Rating: 2
And all the people who get it from non-sexual exchange? Screw them right?


RE: I Already Have My HIV Prevention Vaccine
By chripuck on 11/8/2012 2:33:36 PM , Rating: 1
Yes, because blood banks still don't screen for it...

Oh, I forgot, there are HIV bandits running around sticking needles in movie theater seats.

There are SOME people that get it via non sexual manners, but this is largely a self-inflicted disease. Put it this way, even if a vaccine was available tomorrow I wouldn't get it for myself.


By leviathan05 on 11/8/2012 2:58:08 PM , Rating: 2
I won't feel safe starting my intravenous drug addiction until I receive this vaccine. I don't know about you.


RE: I Already Have My HIV Prevention Vaccine
By tayb on 11/8/2012 6:41:01 PM , Rating: 2
quote:
There are SOME people that get it via non sexual manners, but this is largely a self-inflicted disease. Put it this way, even if a vaccine was available tomorrow I wouldn't get it for myself.


I have an acquaintance who works as a night nurse who was infected with HIV from a patient freaking out during some test or blood drawing. It's not just self inflicted. Accidents happen.


By JonnyDough on 11/10/2012 2:39:45 PM , Rating: 3
Not to mention that HIV-1M has been calculated to have been around since at least the early 1900's, and an estimated 3 million people or so around the world are affected by it annually. It's sad that I can tell when my fellow American's post by their ethnocentrism. Hey self-indulged children, guess what? The world is bigger and more important than just you.


By ClownPuncher on 11/8/2012 2:55:02 PM , Rating: 2
Neat post, as usual.


By KITH on 11/8/2012 6:48:47 PM , Rating: 2
Yeah, you're an athol, all right.


"We’re Apple. We don’t wear suits. We don’t even own suits." -- Apple CEO Steve Jobs














botimage
Copyright 2014 DailyTech LLC. - RSS Feed | Advertise | About Us | Ethics | FAQ | Terms, Conditions & Privacy Information | Kristopher Kubicki