HIV/AIDS Vaccine To Begin Phase I Human Trials

An anonymous reader writes "An HIV/AIDS vaccine developed in Ontario has applied for Phase 1 human trials. Safety and immunogenicity studies of the vaccine, dubbed SAV001-H, have already been completed on animals. Phase 1 human trials will check the safety of the vaccine on HIV positive volunteers. Phase 2 will then test immunogenicity."

Comments

Which is It?

[sexconker]

Is this a vaccine for the virus, as one with half a brain would assume?

Or is this a magic serum that cures you of AIDS while not dealing with HIV?

HIV/AIDS is stupid.
HIV and AIDS are separate, though related, things.

Think of the confusion:
Person with AIDS gets vaccine and thinks it's okay to have unprotected sex willy-nilly.

Re:Which is It?

[Excelcia]

HIV/AIDS is stupid

Are you trying to promote the HIV doesn't necessarily cause aids point of view?

The vaccine in question does as any viral vaccine does, which is to help prevent an exposure to a virus from turning into an infection. In this case, it is intended to help prevent exposure to HIV from becoming AIDS. Once exposure has progressed into an infection, vaccines have little, if any, efficacy.

Re:Which is It?

[Anonymous Coward]

What about GNU/HIV/AIDS?

Re:Which is It?

[Flea of Pain]

Researcher1: Are you sure this will work? Researcher2: Not only am I sure, I'm HIV positive! Sorry, had to throw a South Park joke in there...

Re:Which is It?

[TheoMurpse]

I've never heard of GNU/HIV.

I have heard of GNU/leprosy, what with the open sores and all...

Test on

[Kryptonian Jor-El]

Phase 1 human trials will check the safety of the vaccine on HIV positive volunteers

Well, at least they're not doing drug trials on animals anymore, better to use those damn AIDS people. Finally good for something

/Sarcasm

Re:Test on

[SlashDev]

Actually drugs trials did take place on African people with AIDS without their knowledge. The would inject them with supposedly malaria drugs, along with other drugs. And test them a few months later...

Re:Cue objections from the religious right:

[Starlon]

Not all of us conservative Christians are superstitious like you illustrate. Some of us even believe in evolution. Some of us don't mind gays getting married. People want to believe that the stereotype is real though, and you don't help the situation.

Is this it?

[davek]

From TFA:

"We hope this vaccine is it, and hopefully this vaccine will prevent HIV infection and save millions of lives." University of Western Ontario professor Chil-Yong Kang.

Human trials are necessary to test the efficacy of the vaccine in protecting against HIV infection because the HIV virus does not cause AIDS-like symptoms in animals, says Kang. However, the immune responses in the animal trials have been promising, he says.

Sounds like if this is for real, HIV will go the way of smallpox and polio. Is this as huge as it sounds?

Re:Is this it?

[geoffspear]

No, because parents will refuse to let their children get vaccinated because that would encourage them to have premarital sex.

Re:Is this it?

[BlueBoxSW.com]

Phase I is really too early to get any hope up. Most "promising" drugs that enter Phase I don't make it to the end of Phase III (FDA approval).

Re:Is this it?

[im_thatoneguy]

I assume that depends on the level of immunity it provides. Are we talking Flu Vaccine or Small Pox vaccine level of protection?

Re:Is this it?

[Jason Levine]

Or because they fear it'll cause autism (ala Jenny McCarthy). Combine the two and you have premarital autistic sex! We can't have that! Won't someone think of the children?

Re:Is this it?

[dunezone]

The question is really if this is a vaccine or therapeutic vaccine, I couldn't find that in the article. The difference being a regular vaccine will prevent the virus from infecting you while a therapeutic will either prevent the virus from spreading in your body but you might still be a carrier or eradicate the virus from you completely thus destroying it.


Just a side note since a lot of discussion on HIV and AIDS. HIV is the virus, the virus attacks the immune system destroying your white blood cells, when your white blood cell count falls below a certain amount per 1mm of blood or some measurement you have AIDS or auto-immune deficiency syndrome caused by HIV.


The virus wont kill you, what will kill you in the end is a basic infection that your body cant handle, even the common cold.

Re:Is this it?

[Opportunist]

Could some mod drop some insightful on that post?

It was pretty much what I was thinking. Vaccine for a highly mutating virus. Good for how long? A day?

What we should wait for before rejoicing is whether the vaccine is still working a year from now.

Re:Is this it?

[rumblin'rabbit]

It wouldn't have to be 100% effective to eradicate HIV. Slowing the spread of a disease can be enough to make it (eventually) disappear.

Re:Is this it?

[haeger]

Except that the kids can't help that their parents are thick as bricks.

Re:Is this it?

[Anonymous Coward]

A few points;
 
1: While you can inject the HIV virus into other animals, the virus will not enter their cells due to the variations between human CD40 and the animals' copy. They can get the virus in them, but it won't do anthing.

2: There are animals whose cell surface ligands are similar enough to the human ones that the virus *does* infect them. if I recall correctly, HIV is capable (though much less efficiently) of entering the cells of certain apes, cats, and armadillos (an eclectic combination to be sure).

3: Of those animals that will play host to the virus, none of them develop symptoms of AIDS. They will host the virus, spread it around, but will not suffer immunoinhibition. This really isn't that uncommon; humans carry several viruses with no measuarble histological effect. This means that there are no suitable animal models for vaccine testing; human testing really is the only viable option.

4:It has long been theorized that the difference between being HIV positive and having AIDS is merely the amount of virus spreading in the system. i.e. if you can keep the viral load low enough, you won't get AIDS. If this is indeed the case, then even a therapeutic vaccine will be a huge step forward in the mortality rates of those infected.

5: Yes, HIV mutates quite quickly. For this reason, the approach that has long been favored is a competitve virus that targets the same cell types as HIV, yet does not have the same level of virulence (a latent infection rather than an actively spreading one). This is the same strategy employed with polio; the original polio vaccine was an actively spreading infectious virus that simply didn't cause the same disease symptoms. It also spread from person to person just like the disease it was meant to treat. This "similar but safer" strategy is likely the only way to have the 'treatment' evolve quickly enough to keep in step with the target. This is also the most difficult type of vaccine for which to acquire testing approval (for obvious reasons).

6: Other vaccine types are much less likely to be effective against a quickly mutating target like HIV. While they may prime the immune system effectively enough against a single strain of the virus, it's much less likely to work against other strains (same reason that you have to get the flu shot every year rather than just once).

7: It was recently shown that HIV can spread through cell:cell junctions. This being the case, it is unlikely that typical vaccines (other than live virus) will be effective, because there is no chance for antibodies (the typical immune system mediator) to interfere in this infection process. Now, it is unlikely that cell:cell spread is sufficient to get viral load to the point of causing AIDS, but it is still a factor to be considered when making predictions about vaccine efficacy (viral clearance is extremely unlikely).

8: This is a phase 1 trial. It's a small scale trial where they're testing for toxicity, not efficacy (phase 2/3). In other words, this trial is designed to answer the question, "is it safe?" It will not answer the question, "does it work?"

how do you test it?

[mofag]

If I take the vaccine and I only sleep with my wife and in 10 years I'm HIV free does it work?

Or is one of the pre-requisites of joining the trial that you commit to sleeping with as many sleeezy whores as you can find?

These are the questions that keep me from being a productive member of society.....

Re:how do you test it?

[TheRaven64]

This is a phase one trial, which doesn't test whether it works, it tests whether it is harmful. The vaccine will be administered to a number of people who already have HIV to see if they have any adverse reaction to it. Presumably the next phase of the trial will be to give it to some people in high-risk demographics and see whether any of them still manage to contract HIV. If they do, then the vaccine doesn't work, although if a smaller number of them contract the disease than would be expected to statistically then it may be worth bringing to market anyway. The final stage will almost certainly involve injecting someone who has been vaccinated with blood from an HIV-positive patient to see whether it really works.

Re:how do you test it?

[religious freak]

That's very evolved of us, and I do agree with the practice. However, I've got to admit a part of me does say "Why don't we give this vaccine to ten creeps on death row, throw them a few hookers and see what happens".

We would have the answer so much quicker and in the end, if the vaccine turns out to be effective, we'll save so many more (important - yes, I said it) lives. Is it really moral to trade the lives of a few dozen creeps over hundreds of thousands of African lives to preserve OUR sense of humanity? Yeah... I guess so... I guess.

No Optimism on HIV

[reporter]

I am not optimistic about this vaccine. HIV mutates at an astonishing rate, and I doubt that one brand of vaccine can prevent an infection.

Right now, we in America -- of all places -- have a silent crisis: an HIV epidemic. Read the shocking article published recently by "The Washington Post". About 3% of the residents of the District of Columbia is infected with HIV. That percentage is roughly the percentage in Uganda and parts of Kenya.

The only way to eradicate this virus is either (1) universal mandatory testing for all Americans and visitors to America (followed by tough enforcement of laws prohibiting unsafe behavior by those who are infected) or (2) a gene therapy that transfers the natural immunity enjoyed by a few Europeans to the American population. As for point #1, mandatory testing is taboo and would never be implemented. As for point #2, a small percentage of Europeans have a cellular mutation that prevents HIV infection.

Re:No Optimism on HIV

[Yold]

(3) Abstaining/reducing risky sexual behaviors. For slashdotters, this shouldn't be a problem.

Re:Cue objections from the religious right:

[localman57]

If you're dumb enough to contract HIV in any way other than a clinical fuck-up, then frankly, I hope you die, and I hope you never managed to reproduce.

Nice sentiment. Until you find out that your husband/wife was not, in fact, on a hiking trip. Suddenly you need an urgent blood test, despite never having done anything more risky than trusting your spouse.

And, just for the record, you should care because empathy is one of the things that separates you from lower species.

It's just phase I testing

[Animats]

Don't get too excited. A few other promising AIDS vaccines have made it this far. Phase I testing is just testing for safety, not effectiveness. Phase II testing is for effectiveness, and phase III testing is for effectiveness in a larger population. VaxGen's vaccine made it to Phase III before it turned out not to be very effective. 95% of the new drugs that make it to the beginning of testing in humans don't turn out to be useful.

Re:It's just phase I testing

[TheMohel]

Amen. The vaccine has showed animal immunogenicity, which is not a bad thing, but since the animals in question don't get AIDS from HIV, their immune systems don't react the same way that human ones do. Which means you need to proceed to human testing, and that takes a long time.

Phase I trials are important, and announcing them is not a bad thing. And nobody particularly expects cures in the HIV-positive population, although circulating HIV may be interesting (if the virus can cause a practical immune response in subjects with HIV but who have fairly normal T4 counts and you can show reduced circulating viral load, you have an interesting data point for efficacy).

My biggest problem with this kind of press release is that they don't include the details. I'd be interested in knowing why this vaccine is likely to work better than the last two hundred that have been tried, what the actual animal studies showed, and so on. Oh well. I'm not going to be waiting up this weekend to hear more. It will be a couple of years before we know whether this one works.

Hicks

[WilyCoder]

When they find a cure for HIV there will be fucking in the streets.

-Bill Hicks

Re:Cue objections from the religious right:

[Calithulu]

Good plan. The next time an atheist comes to my door to preach at me I'll just tell them to go away. Oh, wait, that never happens.

On the other hand, evangelical religious folk do come to my door and try to convert me or, as has happened int the past, try to convince neighborhood kids to join their church when they think the parents aren't home.

Re:Cue objections from the religious right:

[mevets]

Sorry, it is the rotten millions that spoil it for the good few.

Re:Cue objections from the religious right:

[schmiddy]

Preposterous. I for one trust my husband completely. When he says he's out on a hiking trip, I know he's out hiking the Appalachian trail, not up to mischief. Perhaps you should be more trustful of your spouse instead of worrying about contracting AIDS.

Sincerely,
Jenny Sanford

Re:How does this work?

[Artifakt]

HIV mutates a lot, but a whole lot of that is thought to be stochastic mutation. The most basic version of this would be where type A becomes type B, but type B also mutates back into type A just as fast, so after a few dozen generations, the population reaches an equilibrium, half of each type. The point is, it's not evolutionary mutation - you have the random mutation part, but until there's some sort of selection pressure, you don't have evolution. There's a difference between having to deal with non directed mutation (which is what stochastic means in this context) and actual evolution. HIV mutates a lot - HIV is NOT evolving rapidly.
      HIV appears to have four types (in this case, of outer protein coats) which are usually called A, B, C & D, but again, nothing is selecting for one type over the others and there's theoretically no pressure for HIV to evolve because of this particular mutation. Some flus have a lot more than four types. Right now, the swine flue that has people worried is type H1N1, and there are six or seven types just for the N part of that classification, and maybe 30 or so total type combinations possible.
      A highly effective vaccine in this case would probably require it make the body's immune system target some part of HIV's protein coat that doesn't usually mutate, just so it doesn't have to fiddle around dealing with the cycle of forward and backwards mutation.

Re:Test: How?

[Tom DBA]

Actually, there are tons of people available for the Phase II and III trials. There's a whole generation of young gays who are catching HIV left and right because they don't use protection.

A great Boon for anyone in the medical field!

[jameskojiro]

Now they won't have to worry about catching aids from trauma patients if a glove fails or if they accidentally nick themselves in the O.R. while working on a AIDS patient.

This should help lower the cost of Healthcare as Doctors may need slightly less hazard insurance once inoculated.

Re:Cue objections from the religious right:

[thesandtiger]

I'm an evangelical agnostic. I'll come to your door for no particular reason.