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Canadians to start HIV vaccine clinical trials

77 points| pg | 14 years ago |ottawacitizen.com

29 comments

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[+] ajju|14 years ago|reply
Kang has been studying HIV since 1987.

This guy has been working on fighting one virus for almost 25 years. I can't quite compare what I aim to do with my startup to preventing HIV, but we certainly hope to have a massive positive impact on the world. So when I feel impatient about changing the world now, this should put things in perspective.

[+] 9oliYQjP|14 years ago|reply
Nobel peace prizes are not normally awarded to philanthropists. But I'm just going to leave this link here. It's a photo of Bill Gates with Prime Minister Stephen Harper announcing funding for HIV vaccine research in 2007.

http://pm.gc.ca/grfx/news/PM-feature-20070220-Gates.jpg

Source: http://pm.gc.ca/eng/media.asp?id=1544

[+] loboman|14 years ago|reply
Does Bill Gates care about this? I wonder how many of the Nobel Prize winners care about it really; they can be very proud about what they did already, who cares if somebody else recognizes them as important?
[+] droz|14 years ago|reply
It is laughable to think that someone who funds research should be given an award. The people doing the actual research deserve an award leaps and bounds above and beyond the one providing funding.
[+] defen|14 years ago|reply
> It will test how effective the vaccine is by comparing a vaccinated and a non-vaccinated group, Kang said in the video.

So I was going to ask how clinical trials for vaccines are done, and this part kind of answers it, but now I'm curious - if there's no control group that gets a placebo injection, how do you control for the fact that people may behave differently if they think they've been given an anti-HIV vaccine? Unless I'm misreading this and "non-vaccinated" means placebo.

[+] redthrowaway|14 years ago|reply
A couple things:

1) We generally know the strength of the placebo effect and the rate of HIV transmission among at-risk groups, so we can control for it, and

2) Not sure the placebo effect is particularly relevant. First, a vaccine that shows little to no benefit over the control (placebo or not) is not an effective vaccine. Second, placebos aren't effective for everything. I highly doubt the effectiveness of a placebo at preventing HIV transmission (although it would be difficult to test ethically).

[+] schiffern|14 years ago|reply
They're placebo controlled. It would be a colossal waste of money to do it any other way. Besides being methodologically unsound, the trials wouldn't be recognized by the FDA or Health Canada.

The University of Rochester has also been working on HIV vaccines for many years. They're always recruiting subjects. The posters are interesting because you can see what stage this particular vaccine is at based on who they're looking for. If they're looking for married, middle-age straight non-injection-drug-users, it's safety trial. If they're looking for young single MSMs or injection drug users, then you know that vaccine has progressed to the efficacy trials.

http://www.rochestervictoryalliance.org/

The 'non-vaccinated' group he speaks of is the placebo group. The reason he mentions it 'head off' anyone assuming they would test it by exposing people to HIV.

[+] ojbyrne|14 years ago|reply
My impression this is going to be something other than a pure scientific experiment (and I don't mean that in a bad way).

Medicine and social sciences have a large body of research about things like the fact that you can't do a pure experiment with a control group if there's serious risks.

http://en.wikipedia.org/wiki/Design_of_quasi-experiments

The seminal work (which I slogged through once upon a time): http://www.amazon.ca/Experimental-Quasi-Experimental-Designs...

[+] baddox|14 years ago|reply
Why does Canada need permission from the FDA?
[+] rdl|14 years ago|reply
They want to make sure the trials are recognized by the FDA as well, so the resulting drug (if successful) can be sold in the US without repeating early stage trials.

Outsourcing clinical trials to other countries (usually India or SE Asia) is one of the biggest advances in drug development in the past 20 years.

The vaccine is also being manufactured in the US for these trials (it requires BSL3, and I don't think there's a Canadian production facility which meets that).