lanl.gov
Couldn't find better sources yet.
A more accurate title, to my ears, would be "HIV vaccine almost ready for human trials."
There are 3 major phases in clinically testing a drug's safety and efficacy before it's brought to market, and it seems like they're close to starting the first one.
For all those interested in the 3 phases, here they are:
Phase 1: Small number of healthy volunteers to assess drug safety, toxicity, and pharmacokinetics.
Phase 2: Small number of patients with the disease of interest to test drug efficacy.
Phase 3: Large number of patients with the disease of interest to test effects of new treatment in comparison to those of existing treatments. This is where you see double-blind studies, etc.
Personally, this isn't terribly noteworthy. They've merely devised a new theory that's shown to be effective using animal models, and are still quite a ways away from seeing if similar results will occur with human testing. Of course, I do hope they see good results.
> Phase 3: Large number of patients with the disease of interest to test effects of new treatment in comparison to those of existing treatments.
I'm not sure phase 2 and 3 make sense for a vaccine though. Vaccines are only useful for healthy people. I guess the testing is done on healthy animals which are then transmitted the HIV virus, unless some people would accept to go through that kind of testing, not very likely but I'm no specialist so I may be wrong.
It reminds me of a study done in IIRC South Africa (although it's been a year or more since I heard of this so it could be anywhere in Africa really) where they circumcised a group of males to see the effect on HIV contraction and it was so great (due to HIV's severely limited lifetime outside the body compared to over viruses and bacteria's) that they ended up circumcising the control group.
Hopefully if this study goes well then they'll do the same. I'd sense a massive lawsuit if scientists caught major wind of a guaranteed vaccine and sat on it for the sake of evidence for 5 years and let X-many people get HIV.
That's why you do this phase in poor countries. Duh.
For instance, contraceptives were widely tested in Puerto Rico in the 50's before being put on the national market in the 60's. They weren't initially sold in Puerto Rico, though, because there wasn't enough money in it yet. [Caveat: I don't know this from personal experience - it's common knowledge in Puerto Rico, but then it's common knowledge here in Indiana that Barack Obama is a foreign-born Muslim, so ... take it all with a grain of salt.]
And it was not the worst case. The US government infected people intentionally with syphilis and gonorrhea in Guatemala during the 40's to research about STD [2], last week the U.S. goverment was sued over those syphilis tests [3].
[1] http://www.youtube.com/watch?v=Brj6RGuB-es&feature=relat...
[2] http://www.msnbc.msn.com/id/39456324/ns/health-sexual_health...
[3] http://www.cbc.ca/news/health/story/2011/03/14/syphilis-guat...
Note that in this case of circumcision the possible negative effects are well known, but a vaccine might have complications in X years that would not be worth the decreased contraction of AIDS. In hypothetical example, perhaps it increases the chances and severity of heart attacks by some ridiculous percentage.
In general, with medicine, it sucks to be on the wrong side of an experiment, but it can be difficult to know which side that is.
Circumcision is still practiced as a coming-of-age rite here by many.
Look again. There have been multiple studies. The ones most often cited were in Uganda and Kenya, and they were real studies. (If only single-blind for obvious reasons.) See http://www.niaid.nih.gov/news/qa/pages/amc12_qa.aspx for more details.
Your criticism is accurate for the South African studies. But we have better data today.
As for the latter statement, there are no "guarantees" before clinical trials have been done (even after it can be iffy: see http://www.plosmedicine.org/article/info:doi/10.1371/journal....
I can't imagine how this argument would look in court.
Considering that all prior HIV vaccine attempts failed completely, sitting on it till they know for sure is exactly what they should do.
And, BTW all those vaccines also came with press releases that touted how great it was, and how sure they were that this time they got it.
Based on past history I would give this vaccine less then 10% chance of actually working.
You seem to be focused on success, but realistically the vast majority of pharmaceutical trials fail.
This is wrong on so many levels.
First, until you conduct the trials have the evidence there is no guarantee that (a) the vaccine works and (b) that it isn't harmful itself. The idea of a guaranteed vaccine that hasn't been through trials is nonsense as trials are an integral part of such a guarantee.
Second, you can't sue someone for with holding such a drug unless you have some sort of basis in law to have that drug - basically a contract between you and the company. As the drug companies can't legally sell a drug that hasn't passed testing no such contracts exist. While I'm sure you'd like to exert some sort of moral right to the drug (and I'd kind of agree with you), a legal right which could form the basis of a law suit simply isn't there.
Third, why would a company sit on a vaccine for AIDS? Yes a majority of those at risk are in the third world and have no money but there is a market of hundreds of millions who could afford and would pay for a vaccine in the wealthy developed world. It simply makes no sense to suggest that they would do anything of the sort.
I would expect you could compare the natural rate of infection in the target group vs the control group after many years taking into account the historical/expected rate of infection in a random sampling of the population involved.
For this reason, travellers to countries where immunoglobulin may not be available are often advised to get the rabies pre-exposure vaccination before they go.
When we last spoke, his white blood cell count was up, and there was literally no trace of the virus in his blood stream; which is to say that while the virus may not have been 100% eradicated, any presence was literally undetectable.
That was over a year and a half ago, and I recently heard that he's still A-Okay, but I've heard surprisingly little about successful trials in the news.
I said elsewhere in the thread as well, but that was my question to him, and he indicated that it was intended to be marketed as a vaccine, but his trial was as a post-infection cure.
I do believe it was the same product.
Edit: It was said above, but the word I couldn't think of at the time was 'antiretroviral'.
Some links here:
It will also mean knocking the people who are convinced the vaccines cause AIDS out of the political world, lest they destroy our ability to do that. This will require action in both the Western world and in Africa, and will make a number of people very unhappy.
I know most people here don't care about those morons. However, any accounting of the cost has to include the political cost.
Many potential vaccines have gone through Phase 1 human trials in the past decade. Phase 1 is hardly the "final" test. It's mainly to establish safety, it doesn't even prove the drug works. AIDSVAX made it all the way to Phase 3 trials, but unfortunately it was not found to be effective.
I've got my fingers crossed, but this is not a particularly newsworthy event.
They did several experiments for HIV drugs. The details are fuzzy, but if I remember correctly, they create a replica of the HIV virus that is totally harmless, but has the same outer cell layer (and reacts to the same chemicals as the real HIV would), and then infect you with that. This allows them to test the interactions with drugs, without giving people real HIV.
After the tests, you receive a certificate saying you are forever HIV positive according to some tests, but that it is a false positive, and using test X it can be verified that you're not really HIV positive. This was important for future medical operations and getting into certain countries that ban HIV-positive people.
Needless to say, you got a lot of money to do these fake HIV experiments.
These people are going to lose their shit as they race to the nearest camera to denounce science for supporting "immoral" sexual activity (read: anything but abstinence) or worse, homosexuality (because HIV can really only be gotten from gays).
It was already pretty bad when the vaccine came out for HPV. In this case it's not hard for me to imagine Republicans blocking any aid to India or African countries (where the incidence of AIDS is highest) that comes in the form of an HIV vaccine, insisting instead that the money be spent on ineffectual abstinence efforts.
Maybe I'm being unnecessarily cynical.
Maybe I'm being unnecessarily cynical.
Taken from, http://www.christiantoday.com/article/catholic.church.warns....
It's pretty amazing that, on Hacker News, a glib throwaway comment like this gets any votes whatsoever. If you disagree with what I wrote you should at least be able to take a minute to write a few well-formed sentences that make a point, instead of leaving this comment that adds nothing.
Now the other group, being low-visibility, is much harder to convince people about, than the high-visibility group of reasons.
Whoever teaches people to refrain from promiscuity may be naturally fond on the high-visibility group of reasons as an easy argument. Should the high-visibility group be dismounted (by successful vaccinations, in this case), it suddenly becomes harder to get the message through. Which was expressed in a slightly roundabound way with, ``and by eliminating [[the highly-visible risk]] [[people may feel greenlighted]] for promiscuous behavior''. In short, a vaccine by itself isn't a message in any direction (it's neutral), but lessens one of messages left there by evolution (STDs).
Uh, that's my take, anyway.
http://en.wikipedia.org/wiki/AIDS_defining_clinical_conditio...
This sounds like it's entering Phase 1 testing. Phase 1 testing is where the drug is tested on healthy volunteers to monitor its effects on humans and whether it's safe and could potentially work. Next it moves on to Phase 2, where the drug's efficacy is tested in addition to safety, in a small number of patients. If a drug succeeds there, it will then move into Phase 3 trials with, usually, hundreds or even thousands of patients. FDA approval generally requires two such Phase 3 trials to succeed. The whole process can take ten years and drugs can and do frequently fail along the way. I wish I had the statistic on hand, but I'd estimate less than 20% of drugs entering Phase 1 trials make it all the way.
On the one hand it makes sense - AIDS/HIV is a national security issue in many ways - I just wonder what that means for everyone outside of the US. If the US government owns the vaccine, are they going to share it openly and without prejudice to any other countries that want it? Even Iran?
But it also makes you wonder, then, whether there is merit in donating to AIDS/HIV research charities if any significant break-throughs are going to be snapped up by the government as matters for national security.
Given this audience, perhaps that's rhetorical question - but I thought worth asking.
Nice to know someone was already hard at work while we were joking around.
In the field of AIDS, vaccine development has been tragically hard.
Probably $8 outside the USA and $80 inside ?
but check out a cool vaccine type here it doesn't use any needles http://gcc.eyeptv.net/blog/2011/03/08/needle-free-topical-ap...
I read sometime ago that the conundrum with AIDS is that the better the immune system response, the faster it spreads. Because the response basically brings it's food to it faster. So vaccines seemed to actually do more harm.
I'm very curious on this, and would hope to see more on this particular story, and with more details than a "almost ready for human trial yay!"