Looks promising..they've been down this road before but it seems to be a much more optimistic starting point. Here's hoping it'll go down in history as another Canadian breakthrough like insulin.
TORONTO — Canadian researchers have received approval to begin human testing of an experimental HIV vaccine.
The U.S. Food and Drug Administration has given the go-ahead to researchers at the University of Western Ontario to test the vaccine, which is based on a genetically modified killed whole virus.
The researchers says Phase I of the clinical trial, which will begin in January, will test the safety of the vaccine in 40 HIV-positive volunteers.
The SAV001 vaccine, developed by Dr. Chil-Yong Kang and his team with support from Sumagen Canada, has been shown to stimulate a strong immune response in preliminary toxicology tests.
If the SAV001 vaccine is found to be safe, it would require two more clinical trials that prove it works before it could be brought to market.
Phase II would measure immune responses to the vaccine in people who are HIV negative but at high risk of infection and Phase III would test the efficacy of the vaccine in a larger group of similarly at-risk individuals.
"FDA approval for human clinical trials is an extremely significant milestone for our vaccine," Kang said in a statement Tuesday.
HIV-AIDS has killed more than 28 million people worldwide, and more than 35 million people currently live with the infection.
There have been numerous attempts by pharmaceutical companies and academic institutions worldwide to develop vaccines, but no commercialized vaccine has yet been developed.
You have to realize that most Christian "moral values" behaviour is not really about "protecting" anyone; it's about their desire to send a continual stream of messages of condemnation towards people whose existence offends them. - Darth Wong alias Mike Wong
"There is nothing wrong with being ignorant. However, there is something very wrong with not choosing to exchange ignorance for knowledge when the opportunity presents itself."
Question: Why does this Canadian University require/need approval from the US FDA? Or is this just part of the process for approving the vaccine's use within the US?
"If it's true that our species is alone in the universe, then I'd have to say that the universe aimed rather low and settled for very little." -George Carlin (1937-2008)
"Have some of you Americans actually seen Football? Of course there are 0-0 draws but that doesn't make them any less exciting." -Dr Roberts, with quite possibly the dumbest thing ever said in 10 years of SDNet.
Question: Why does this Canadian University require/need approval from the US FDA? Or is this just part of the process for approving the vaccine's use within the US?
I think it just means that they meet the requirements of being accepted as a legitamate clinical trial. The States are mentioned because...well...it's America. The most influential country in the world and arguably the focal point of the epidemic from a public viewpoint..(although realisticaly Africa was and is the true genesis and hot bed).
You have to realize that most Christian "moral values" behaviour is not really about "protecting" anyone; it's about their desire to send a continual stream of messages of condemnation towards people whose existence offends them. - Darth Wong alias Mike Wong
"There is nothing wrong with being ignorant. However, there is something very wrong with not choosing to exchange ignorance for knowledge when the opportunity presents itself."
Darth Fanboy wrote:Question: Why does this Canadian University require/need approval from the US FDA? Or is this just part of the process for approving the vaccine's use within the US?
The latter. It's basically the FDA saying that they've reviewed the plans for the trial and the experiment design, and that they're prepared to accept the results as legitimate. Legally, that's only important if (realistically, when) they want the vaccine approved for use in the U.S., because having the trial design already approved will speed up the review process. The FDA is also pretty rigorous in its standards, so having the trial's design vetted by them may also make other regulatory agencies take the trial more seriously. It's a way to say "No, this isn't a b.s. experiment "sponsored" by a drug company to show how wonderful their new product is. We had a third party check and certify its design beforehand."
Question: Why does this Canadian University require/need approval from the US FDA? Or is this just part of the process for approving the vaccine's use within the US?
I think it just means that they meet the requirements of being accepted as a legitamate clinical trial. The States are mentioned because...well...it's America. The most influential country in the world and arguably the focal point of the epidemic from a public viewpoint..(although realisticaly Africa was and is the true genesis and hot bed).
Infection rates in the States are rising again, too. Modern treatments are good enough that HIV-positive Americans aren't progressing to AIDS and dying within a few years for the most part (as long as those treatments are available, the programs have suffered some major cuts in the last few years) and so it isn't hitting the public awareness the way it did in the 80s, but HIV is still a major, major problem in the US.
A vaccine would be amazing. I won't let my hopes get too high because we've been down similar paths before, but I can't even think of words that would accurately convey my feelings if this one actually works.
"You were doing OK until you started to think."
-ICANT, creationist from evcforum.net
I've recently seen a story about a gene therapy / vaccine in development.
The idea was that HIV is hard to vaccinate against as the virus kills the cells that would produce the anti bodies you want to target the virus. This version instead of working on white blood cells instead caused muscle tissue to produce anti bodies, the HIV can't target the muscles so cant overcome the anti body production and is over whelmed. Its a rather unique idea although I assume it can't be down regulated i.e. you would continue to produce anti-bodies for the whole of your life regardless of if you were infected or now where as for normal vaccines your body would up regulate when you get infected and have a low anti body load the rest of the time.
As mentioned, the obstacles in getting an effective vaccine against HIV have been immense. We don't have a wonderful track record on viral diseases in the first place as a rule with a couple of notable exceptions...But we are getting more and more capable of getting down to the nitty gritty of cellular life so to speak and I honestly think that we'll see tremendous advances in the next couple of decades.
That being said, I'll cross my fingers this current trial will bear fruit. I presume it's only useful in preventing infection and not in any way helpful in combatting it once contracted. There were some studies I remember seeing fairly recently that seems to suggest they were having some marked success along that front as well..but I don't think this would be anything more then preventative at best.
You have to realize that most Christian "moral values" behaviour is not really about "protecting" anyone; it's about their desire to send a continual stream of messages of condemnation towards people whose existence offends them. - Darth Wong alias Mike Wong
"There is nothing wrong with being ignorant. However, there is something very wrong with not choosing to exchange ignorance for knowledge when the opportunity presents itself."
