HIV vaccine trial approved by FDA

[Gokulo]

Remembering/finding if something was already posted in General is quite a headache, but I don't remember seeing that, so:

http://www.cbc.ca/news/health/story/...e-western.html

A vaccine that may prevent HIV has been given the green light by the U.S. Food and Drug Administration to begin clinical trials in humans, according to Canadian researchers.

The announcement was made on the campus of the University of Western Ontario in London, Ont.

"We have gone through so many different challenges to come to this point," said Dr. Chil-Yong Kang, a researcher and professor at Western's Schulich School of Medicine and Dentistry. "This is the first time that I feel very happy and comfortable to initiate this human clinical trial."

Scientists at the University of Western Ontario, financially backed by the pharmaceutical venture company Sumagen, developed the vaccine, which is based on a genetically modified killed whole virus. The vaccine stimulated a strong immune response in early testing and appears to have no adverse effects, according to the researchers.

"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 There have been three clinical trials for an HIV vaccine in the past using live viruses that failed. (Apichart Weerawong/Associated Press)
Kang.

He said there have been three clinical trials for an HIV vaccine in the past using live viruses. "None of the researchers in the past have used this approach," he says of his use of a killed virus.

The vaccine, SAV001, will now have to undergo three phases of human clinical trials;
Phase 1. Beginning in January 2012, this phase will involve 30 HIV-positive people on whom safety will be retested.
Phase 2. This phase will examine immune responses in humans and will involve 600 HIV-negative people who are at high risk of contracting the AIDS virus.
Phase 3. This phase will determine the efficacy of the vaccine and will involve 6,000 HIV-negative volunteers at high risk of contracting the virus.

[Mazmaz]

I saw this. I don't understand how just giving the vaccine to people who are at high risk and if they don't get it, it proves that the vaccine works.

Also, excuse me for not being excited, but even if this works, watch the vaccine cost like $10k.

[Guyverarmor]

I saw this. I don't understand how just giving the vaccine to people who are at high risk and if they don't get it, it proves that the vaccine works.

Also, excuse me for not being excited, but even if this works, watch the vaccine cost like $10k.

I agree with the monetary cost as Maz brings up. Pharm companies would charge out the ass for something like this... it's been one of the top dreams of all scientists to create a vaccine for HIV, everyone will want to capitalize on this.

[Salodin]

And it won't be covered by insurance companies :3

[Not Kuno]

I agree with the monetary cost as Maz brings up. Pharm companies would charge out the ass for something like this... it's been one of the top dreams of all scientists to create a vaccine for HIV, everyone will want to capitalize on this.

Just wait till it gets Bill Gates'd up.

[Diamicles]

The chances of any drug/vaccine getting past phase I is pretty terrible. Doubt anything will come of this for at least 6-7 years, if anything. Working in the contract pharma research field for almost the last 8 years, you don't really see nearly as many drugs get approved as you would think. Vaccines are a little bit more plausible to get through the clinical testing than most other APIs.

[Mazmaz]

Also, if this is being done in Canada, why did it need FDA approval?

[Correction]

Also, if this is being done in Canada, why did it need FDA approval?

FDA approval is required to market/sell drugs here.

[Restrat]

I saw this. I don't understand how just giving the vaccine to people who are at high risk and if they don't get it, it proves that the vaccine works.

They will take an equal number of high risk people, give them a fake vaccine, and at the end see if one group had significantly less HIV infection than the other

[Snprphnx]

it would be covered by insurance, due to the cost/benefit of paying for the vaccine vs. paying for treatments and prescriptions of someone already infected

[Chun Liroy]

They will take an equal number of high risk people, give them a fake vaccine, and at the end see if one group had significantly less HIV infection than the other

That leaves far too much up to chance.

[Restrat]

thats why you have to use 6000 people

[Chun Liroy]

So then how are you going to decide who is "high risk" for HIV? It's not going to be clear as something like diseases spread through the air. Ethics won't allow for the introduction of HIV into someone that took the vaccine so I think it's unlikely that we'll be able to quantify the effectiveness unless something extreme occurs (majority of the vaccinated group contracts it or little to none of them get it).

[Cream Soda]

High risk will be
1) Black people
2) People named Quincy

[Milkster]

Those that engage in high risk behaviors. Sex with multiple partners (unprotected), sharing needles, etc.

You most likely have to fill out a survey about your life story.

[Chun Liroy]

So then how do you quantify it? Like does such and such have a 90% chance of contracting the disease over x months because of xyz in their life?

[Restrat]

thats what the control group without the vaccine is for. people with similar risk- maybe 10% of them got HIV after two years. If the people with the vaccine only had 1% get HIV, that would suggest it was the vaccine made the difference

[Chun Liroy]

Tests, or rather studies, would first have to be done on the effects of certain actions on the risk of HIV. Now, I don't know if this was done or not yet, but it would have to be done to determine the standard deviation and to verify if the results are significant enough. If 50% of the control group get it and 40% get it in the experimental group, these numbers mean nothing without the right context and correct statistical figures.

[Jefe]

Sooooo nobody wants to say high risk peeps are the gays, huh?

[Milkster]

Anal sex puts anyone at higher risk due to the lining of the anus being so weak/thin/sensitive.