HIV vaccine developed in Canada approved for human studies, page 1

Hey there guys,
I just stumbled onto this here, and so it seems as you can see by the title, that they are going to start human testing with this vaccine.
I don't know how they are going to accomplish this, give them the shot, then try to give them HIV? I dont know who would want to do that.. Anyways, here it is.

A Canadian-developed vaccine to prevent HIV has been given the green light for testing in human clinical trials.

The vaccine, developed by researchers at the University of Western Ontario, has been approved by the U.S. Food and Drug Administration to start being tested in humans in January.

It is the first preventive HIV vaccine approved for clinical trials to use a whole HIV-1 virus, which has been both killed and genetically engineered, to activate immunity. In this way, the new vaccine is much like the killed whole virus vaccines that are successful against polio, rabies and influenza.

Other HIV vaccines currently in clinical human trials have largely focused on one specific component of HIV to trigger an immune response. Right now, there is no effective HIV vaccine.

“FDA approval for human clinical trials is an extremely significant milestone for our vaccine, which has the potential to save the lives of millions of people around the world by preventing HIV infection,” said Dr. Chil-Yong Kang, professor of virology at the Schulich School of Medicine and Dentistry at the University of Western Ontario, in a release.

The announcement was made Tuesday morning in London.

The vaccine, the only HIV vaccine being developed in Canada, received funding from Sumagen Canada, a company created in 2008 to support the development of the vaccine.

Previous studies have shown the vaccine triggers a strong immune response and has yet to show any adverse effects or safety risks.

While it's an advance, me personally would never get this. I hope they don't decide to start giving it to children either to 'protect them', FDA approval usually means bad. lol.

But Its definatly on its way to a cure, because prevention still will not help people who already have it.

Source

reply to post by JiggyPotamus

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It is impossible to get HIV from the vaccine. They're doing this to find out if it works, so it's not certain that I would be protected against the disease if I were exposed to the virus in someone else's bodily fluids (i.e. the regular way people contract HIV). The vaccine is actually made from a modified flu virus that contains some dna from HIV. The HIV dna can't infect you with the disease, but it can (if it works) cause your body to create anti-bodies to actual HIV, meaning your body could defeat the virus if you were ever exposed to it. The part of the flu virus that would make you sick is also deactivated in the vaccine.

I haven't had any side effects at all, and I know that no one in this study has had any serious side effects. There's a pretty standard set of mild side effects that are extremely common in most vaccines including a mild fever and soreness or swelling at the injection site, and people in this study have had those sorts of symptoms.

wow they are actually going to use the whole killed virus? The problem with trying to establish immunity with the standard method of invoking a T-cell response is the T-cell is the target of the virus and the virus has too many ways to inactivate and hijack the machinery of the T-cell. But there may be details, something different, that makes them think this will work. There is another vaccine inducing a T-cell response in trials in Spain (see below). But I hadn't heard about this one until today.

There are many attractive concepts that are in trials or headed for trials, that use some type of gene modification to either establish an immunity to a group of T-cells that can proliferate and attack the virus, or to make the body manufacture the antibodies that have been identified in the long-term non-progressor studies (two antibodies isolated from these groups that neutralize the virus and make them immune to it). There are studies that may be headed for trial using drugs that are made of antibodies duplicated from the long-term non-progressor trials (already duplicated and tested sucessfully in the lab). And those concepts are therapeutic and preventative (not just preventative as the OP trial).

There is also another Spanish MVA-B vaccine trial www.sciencedaily.com... aiming to activate T-cells using other components of the virus, already in trials for over a year, that is having good results. 85% have immunity for a year. Who wants to gamble with the 15%? Any takers? Now if there was something to cure or make it harmless, and a vaccine to prevent, then that new trial with the 15% failure rate could be more attractive and much cheaper for the healthcare system as a whole.

Everyone should keep their eye on the concept that uses a vaccine that is injected into muscle tissue, and then the tissue manufactures an antibody specific to the vaccine encoding. www.sciencedaily.com...
It's proven in animal models and will most assuredly be going to trial if not already in trial.

The reason this technique is so promising, is that it will work for ANY antibody that can be identified or manufactured in a lab for ANY condition that can be treated this way (i.e. diseases, tumors or malignancies). And there is most assuredly a guinea-pig group of people ready to test it for the rest of the world.

To the OP and others, it (the Canadian vaccine trial) is not the first or only, and it's not really inspiring, I thought the whole-virus road was not only a dead end, but the first dead end they would have tried a long time ago. What's different about this approach than the dead road of the 90's? They didn't say much about that.
Well, maybe, there is something different I'm not seeing, and of course I hope so. The trials may begin.

reply to post by tinker9917

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I get about 50 dollars per visit and have about 8 visits over the course of about 16 months, but, I don't do it for the money. I know they need volunteers, and it's hard to find people who fit the profile - biologically and in terms of lifestyle/risk factors - that they need and who are willing to put their trust in the scientists. I think the less you know about how the process works and what's really going on biologically, the more you perceive it to be a risky undertaking.

I don't think there are significant risks. I work as a scientist at the research institution conducting the study, which is how I learned about it (different department and no personal relationships with the people conducting the study though, so no conflict of interest, plus I'm not identified to the researchers by anything other than a randomly assigned number - only the nurse that gives me the shots and an offsite database belonging to the NIH know who I am in relation to the study). I have a high level understanding of what the vaccine is and the relevant biology, as well as a familiarity with the precautions in place and the standards and reputation of the institution that's running the study. Based on these things, I'm quite confident that what I'm doing is posses very little risk. For example: there's no theoretical basis for the vaccine being harmful to humans; they tested it in appropriate animal models first; there have been trials of similar vaccines in humans without serious side effects; they monitor my health throughout; and there's a independent panel of doctors with nothing to gain from these experiments who review my general health and various test results during and after the study, who would definitely stop my involvement in the study (or stop the entire thing, if it were serious) and direct my treatment if necessary - if it appeared I were having any issues.

The only precedent for unacceptable side-effects in an approved modern American HIV vaccine study was during something called the STEP study. Participants in that study were found to contract HIV at a higher rate than comparable populations not receiving the vaccine.

STEP was the name for a double-blind randomized controlled trial managed by the HVTN. It was thoroughly reviewed when a greater number of participants in the experimental group contracted HIV than the participants in the control group. The vaccine contained no HIV and no one could have contracted HIV from the vaccine, but there was intense discussion as to whether the vaccine could have increased anyone's risk of contracting HIV. Because the study was stopped early, it probably will never be possible to determine why more participants in the experimental group contracted HIV, but various theories have been proposed.

See the Wikipedia article if you're interested.

It is likely that the vaccine increased the risk of contracting HIV due to conventional exposure (i.e. unprotected sex with HIV positive people, sharing needles, or otherwise being exposed to the bodily fluids of an infected person). The group in that study was intentionally selected to be extremely high risk: i.v. drug users, homosexuals, and sexually promiscuous people who didn't use condoms. This doesn't concern me though, because the vaccine that I am being given is not similar to the one they received, and my lifestyle puts me at very low risk for infection.

I've worked in the vaccine industry for going on 10 years.

I wouldn't take one unless I was tied down and forced. Of course that wouldn't be possible but is another story for another day.

I can't tell you what to do since you alone are responsible for what is injected into your body but can say that I have determined it is better to be unemployed than to allow myself to be forced to take one.

My avatar wasn't chosen for nothing.

There are a number of us who refuse to take the shots and joke about it amongst ourselves. Generally I have to explain to people what the excipients are/do and much more importantly what the adjuvants are/do.

You don't need to have a degree in biochemistry to realize how toxic the mix is. Give this site a look and make that determination for yourself.

www.novaccine.com...

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