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AIDS vaccine in final testing (lanl.gov)

381 points by swombat ↗ HN
I hate to quote the Daily Mail, but this is also a good source (perhaps better): http://www.dailymail.co.uk/health/article-1371540/Mosaic-HIV-vaccine-imminent-Scientists-begin-trialling-breakthrough-drug-year.html

Couldn't find better sources yet.

83 comments

[ 4.2 ms ] story [ 136 ms ] thread
bmelton
A friend of mine was in pretty bad straits with the AIDS virus, full blown, and got into early clinical trials in a potential AIDS cure (don't know if it's this or not).

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.

ChuckMcM
The title seems to be off, from the article: "... she and her team gear up for the first round of human trials of an HIV vaccine." from that it sounds like they are starting human trials. As I this is not the first vaccine to get to this stage, it's certainly not what your friend was given (I assume your friend is human) as they haven't tested on humans yet.
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jules
That must have been a different thing right? Because vaccines don't work anymore when you're already infected? But still that's amazing news!
bmelton
Depends on the vaccine. There have recently been a number of vaccines that claimed to work after infection as well.

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'.

dstein
A vaccine would prevent you from getting aids, but probably not cure it.
bmelton
To wit, I believe it is both a vaccine and a cure, though again, I'm scarce on details -- but I had the same question for him when he first told me about it.
MScStudent
its hard to believe it would be a cure cause HIV mutates quite rapidly in people creating a fair amount of resistant strains
thisrod
That's normal. HIV, the virus that causes AIDS, is now easy to treat. It hasn't killed many rich people for 15 years.
bmelton
Not to take anything away from your comment, but he was well past having just HIV, and full bore into AIDS, and he was also not even remotely wealthy. Having graduated from living in his car full time to a 180 square foot apartment just before his uninsured car was stolen.
peripitea
He probably meant "rich" in the global sense.
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GrandMasterBirt
True, that is incredible that we can kick this disease pretty hard now. However the problem still stands, the only known solution is a bone marrow transplant and that requires a corpse + a 50/50 chance to die.
catch23
I'm guessing he wasn't sick in the USA, since you actually need to be rich to pay for specialized healthcare here.
SandB0x
20 years, for Magic Johnson.
redthrowaway
He has to be a statistical outlier. Freddie Mercury had cash too, but that didn't save him. Same for Easy E. I'd be very interested in studying Magic's genotype and seeing what makes him so special.
redthrowaway
Modern antiretrovirals are very effective. Combined with a healthy immune system, it's entirely possible for HIV to be present, but knocked into submission. Both health risks and chances of propagation are significantly reduced. That doesn't, however, mean the virus has been eliminated.
GrandMasterBirt
So the great part of this is that pretty much you can live to a ripe old age. The issue is price. If we can TREAT it for a person's life, thats great. That is no solution for a massive epidemic in Africa though where we'd be lucky to vaccinate everyone if we could, nevermind a long-term treatment.
redthrowaway
Africa's always going to be a problem. Assuming this vaccine is effective, we need to take the same approach to HIV that we did to smallpox. That will likely mean substantial Western subsidies for poorer nations, and a concerted boots-on-the-ground effort to administer the vaccine. It will be a long time before HIV is eliminated, and it will come at a substantial cost to taxpayers, but it's well worth it to rid ourselves of this disease.
derleth
> That will likely mean substantial Western subsidies for poorer nations, and a concerted boots-on-the-ground effort to administer the vaccine.

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.

qeorge
That's awesome, happy to hear he's doing so well.
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Roritharr
When i was 8 or 9 years old me and my best friend always fought about who would cure aids and who would cure cancer when we were grown up. Now i'm 23 years old, and went into CS instead of medicine although i had the possibility and had nearly as much interst in the field as in CS.

Nice to know someone was already hard at work while we were joking around.

scott_s
Title is misleading. To me, the headline "AIDS vaccine in final testing" implies that they are undergoing their final testing to verify that it does indeed prevent people from contracting HIV. That is not what it means. Rather, it means that they are in the final rounds to verify that the vaccine is safe, before they start human trials.

A more accurate title, to my ears, would be "HIV vaccine almost ready for human trials."

sabat
You're correct about what stage they're at, but this is still very exciting news.
reason
Yes, you're correct.

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.

patrickaljord
> 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.

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.

evgen
For vaccines you test against a population and compare disease rates between the people who received the vaccine and those that did not. In situations like this I would guess that they will select a high-risk group and then compare infection rates over time between the two groups to see if the vaccine has any effect.
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jessriedel
As explained elsewhere, you give the vaccine and a placebo to an at-risk. Than you follow up X years later to check infection rates. Everything's double blind, so there's nothing statistically different about the two populations other than the vaccine vs. placebo.

http://news.ycombinator.com/item?id=2389732

electromagnetic
Super-sucks to be in the placebo group on this one if the vaccine really works.

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.

Vivtek
I'd sense a massive lawsuit if scientists caught major wind of a guaranteed vaccine and sat on it

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.]

pdelgallego
It is well documented, this a good documentary about it [1]

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...

scott_s
Super-sucks to exist in a world without a vaccine.
aharrison
I'm reminded of this story I heard not too long ago: http://lesswrong.com/lw/37k/rationality_quotes_december_2010...

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.

mdpm
That was South Africa (I'm here). That wasn't a study on circumcision, that was nothing more than a statistical correlation, and one without any established causal relationship to support the 'prevents HIV' claim. There are many other factors to explain the correlation - cultural, economic and demographic.

Circumcision is still practiced as a coming-of-age rite here by many.

btilly
That was South Africa (I'm here). That wasn't a study on circumcision, that was nothing more than a statistical correlation...

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.

XFrequentist
It's tricky: there is often monitoring of interim results for exactly this reason, but there are some good theoretical reasons to think that halting a trial on the basis of good interim outcomes in the experimental group could bias the results.

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.

ars
> 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.

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.

SapphireSun
Getting a false positive result because you screwed your significance test because you decided to stop early? When you release it to the public, people think they're protected, so many more people than X die.
rms
Use Bayesian statistics!
Tyrannosaurs
> 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.

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.

allending
Don't know much about drugs and trials so I am speaking out of my ass but I'd assume if the numbers were large enough, you don't actually infect the patients.

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.

loxs
This is not true. There is no biological reason why a vaccine wouldn't work on an infected individual. What you say is a myth, mostly as a result of most vaccines being about accute infections, like smallpox. In those cases, there is no real idea in administering a vaccine to a person who is already ill, because by the time the immune system is ready with its strong specific answer (which is a matter of days), the patient would be either dead or cured by "natural" response to the virus. There are already vaccines targeting (successfully) diseases with a long incubation period. Examples for this are tetanus and rabies. You get your vaccine after being bitten (by a rat for example), and you are OK.
chris_j
In the case of rabies treatment, if the patient has not received the rabies pre-exposure vaccination then they must receive a dose of immunoglobulin (antibodies against the rabies virus) in addition to the rabies vaccine. Without it, the patient would die before their immune system would be ready to fight the virus. Receiving the dose of immunoglobulin gives the immune system enough time to start producing its own antibodies.

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.

eli
This is a very misleading headline.

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.

mirkules
I always wonder how they actually test if a vaccine against lethal diseases is successful in humans. I can't imagine there are volunteers who sign up to be injected with a vaccine and then get injected with a live HIV virus, just to see if the vaccine works. Or do they just inoculate volunteers from the highest "at-risk" population -- but then, how do they measure if people have been exposed eventually to the virus or not?
kenjackson
You do double blind against a placebo with an at risk group. Then in X years you look at infection rates with survey data to complement it.
mirkules
If I understand this correctly, it's all about finding a best-fit model for the change in infection rates after X amount of years. There could be a number of factors at play (environmental, political, religious), but the "correct" cause of change will stick out like a sore thumb.
relix
When I was in university, the university hospital used to do a lot of medicine trials. Basically, you get paid to be a guinea pig.

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.

losvedir
While this is a promising first start, it looks like it's a long way from being a working, FDA approved therapy.

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.

chubs
This is pretty amazing news if true. Imagine the flow-on social effects of aids being reduced (or even eradicated!) in africa. Less orphans brings less poverty brings higher education, less violence, it really is going to be a big deal when someone finally makes an aids cure
dotBen
I'm curious a to why this vaccine has been worked in at Los Alamos which is a national security orientated government laboratory. (US government, of course)

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.

wgrover
I think there's an easier explanation than national security. There's a huge variety of research going on at all the National Labs. Their place within the Department of Energy motivates the development of unique energy-related resources (supercomputing, particle accelerators, you name it) which then find uses in fields like biology. At first glance, it looks like LANL's computing expertise facilitated this vaccine research.
dotBen
Very probably. Point still stands though, what's the point of funding independent AIDS/HIV research if the government is funding it on a national security agenda.

Given this audience, perhaps that's rhetorical question - but I thought worth asking.

danenania
Even if they wanted to, there's no way they could keep it in their control. Medical researchers aren't soldiers; if a cure was found and the government was crazy enough to try to control it, instructions for synthesizing it would be on the web in five seconds.
jessedhillon
If this ever materializes as a widely available, easily administered vaccine, can you imagine the uproar from so-called religious folks in the US? A vaccine which safely prevents one from contracting an STD that is a killer of millions.

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.

dandelany 

  Maybe I'm being unnecessarily cynical.
Yup.
jessedhillon
I don't think I'm being cynical but I'm open to the possibility. The response from the religious groups to the HPV vaccine was very much along the lines of what I laid out in my original comment. Here's a Catholic perspective on the matter: "...and by eliminating one element of risk it might act as a green light for promiscuous behaviour,” said the Catholic Church spokesman.

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.

dexen
There are two groups of reasons to refrain from promiscuous behavior. One is the high-visibility, high-impact kind of reasons, like risk of infections. The other is the low-visibility, high-impact kind of reasons, like effects on morality, family relationships and whatnot.

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.

ars
If you really believe what you wrote (and I have a hard time believing you believe it) then you are reading reddit (or sites like it) WAY too much.
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andresmh
I worked at Los Alamos as an undergrad. I didn't know they did bio research. Go LANL!
GrandMasterBirt
So honestly while I am super excited about the possibility of AIDS being a fear of the past, heres my criticism:

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!"

ck2
So is it going to be $8 or $80?

Probably $8 outside the USA and $80 inside ?

yason
As long as people won't let go of their urge to inflict their guilt into various lethal diseases we'll always have enough of them; double so for sexually transmitted diseases.
bnegreve
Assuming that this vaccine "works", can it be of any use to people that already contracted AIDS ?
berito
I am going to go get some with the filthiest tonight!
[dead] berito
I am going to go get some with the filthiest tonight!
gohat
This has almost no value. This basically says that a proposed vaccine has shown some signs of efficacy in animal models and has not even been tested yet in humans as to whether or not it is safe.

In the field of AIDS, vaccine development has been tragically hard.

takameyer
While I'm happy to hear this promising news, this article could really use more beef. Anyone have some good references or additional information on this topic?
antihero
Wouldn't you have to have balls of steel to do human testing for this? If it doesn't work, don't you essentially contract HIV?