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HIV/AIDS Vaccine To Begin Phase I Human Trials 329

Posted by timothy
from the soon-enough-mandatory-like-gardasil dept.
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."
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HIV/AIDS Vaccine To Begin Phase I Human Trials

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  • Which is It? (Score:5, Insightful)

    by sexconker (1179573) on Thursday July 02, 2009 @03:23PM (#28562527)

    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: (Score:2, Insightful)

      by Absolut187 (816431)

      This is a vaccine against getting the HIV virus in the first place.

      There is no "magic serum" that cures AIDS. If you want to cure your AIDS, you need to have sex with a virgin, preferably an infant.
      http://www.snopes.com/inboxer/petition/babyrape.asp [snopes.com]

      • Re: (Score:2, Funny)

        by eneville (745111)
        Michael Jackson beat you to it.
      • by Flea of Pain (1577213) on Thursday July 02, 2009 @03:55PM (#28563191)
        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: (Score:3, Informative)

        by Hojima (1228978)

        I would use my mod points to help you, but I think it's best to post a reply telling future moderators that the above is not a troll. That is what I thought before clicking the link. This is in fact a post spreading the awareness of child abuse in South Africa (at times resulting in gang-rape of an infant) because of the foolish and terrible myth that having sex with a virgin infant can cure your AIDS. Click on the link and help with the petition if you are interested

      • by nedlohs (1335013)

        Vaccines don't cure things so there's no need to specify that. The unusual case would be a vaccine that did cure an existing condition that would be worthy of mentioning.

      • Re: (Score:2, Funny)

        by martas (1439879)
        since this post is 4 insightful, i'm going to assume that having sex with a virgin infant (as opposed to a slutty one) really is going to cure my AIDS.
    • Re:Which is It? (Score:5, Insightful)

      by Excelcia (906188) <kfitzner@excelcia.ca> on Thursday July 02, 2009 @03:41PM (#28562931) Homepage Journal

      HIV/AIDS is stupid

      Are you trying to promote the HIV doesn't necessarily cause aids [wikipedia.org] 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.

      • No I'm not.
        Are you trying to promote that they are the same thing?

        • by Anonymous Coward on Thursday July 02, 2009 @03:55PM (#28563189)
          What about GNU/HIV/AIDS?
        • Re: (Score:2, Insightful)

          by Excelcia (906188)

          Are you trying to promote that they are the same thing?

          Of course not. No more than the common cold is the same thing as the enterovirus that causes it.

          There has always been a differentiation between illnesses and the viruses that cause them. Partially because sometimes there is more than one virus that causes a given named set of symptoms, but mostly because of the simple fact that knowledge of illness predated knowledge of viruses. Because people think of HIV in terms of the illness it causes, we are

          • Re: (Score:2, Informative)

            by lazy_playboy (236084)

            Of course not. No more than the common cold is the same thing as the enterovirus that causes it.

            Common cold is most commonly caused by rhinovirus.

        • It's like developing a vaccine for the common cold instead of rhinovirus, or getting your pets vaccinated against rabies as opposed to the lyssa virus. Medicine and society are entrenched with diagnosing and preventing symptoms.
    • Re: (Score:3, Insightful)

      by Ian Alexander (997430)
      If you have AIDS you're probably better-educated about your syndrome than your average bear.

      I find it highly improbably that anyone could confuse AIDS and HIV that badly; I was educated on the difference in middle school as part and parcel of the health curriculum.
    • Re: (Score:2, Redundant)

      by sexconker (1179573)

      Did anyone read my post, or my own reply?
      No, guess not.
      And no one will read this.

      I KNOW THAT THIS IS FOR HIV.
      MY BEEF IS THE USE OF "HIV/AIDS" IN THE HEADLINE.

      • by SUB7IME (604466)
        Within the medical world, we routinely talk about HIV/AIDS. The former is the sine qua non for the latter. Preventing the former leads to prevention of the latter. Thus, a successful vaccine will prevent HIV/AIDS.
        • When administered properly and completely to a properly educated populace, yes.

          There's a place where that's a huge fucking task.

    • by slapout (93640)

      "HIV/AIDS"

      Have you ever heard the media mention the term "HIV" without immediately following it with "the virus that causes AIDS"? It's the media that's bonded those terms.

    • by nedlohs (1335013)

      No way!

      Vaccines just stop you getting the thing, rather than curing you once you already have it.

      Who knew?!?

      It's pretty obviously (without even RTFA) a vaccine for HIV with the intention of hence stopping you getting AIDS if you get exposed to HIV later. Like every other bloody vaccine in the universe.

      You confusion is stupid. No one with AIDS would be given the vaccine since it's pointless at that point. Even if they were why would they think it would stop them infecting others? Do people who get flu shots

      • No one in the US maybe.
        There's a place where this confusion might cause actual problems, though.

  • Test on (Score:4, Funny)

    by Kryptonian Jor-El (970056) on Thursday July 02, 2009 @03:25PM (#28562583)

    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: (Score:2, Funny)

      PETA will be happy.

      • Re: (Score:2, Informative)

        by Anonymous Coward
        Haven't you heard, we humans are monkeys! This is clearly PETA's jurisdiction.
    • Re: (Score:3, Interesting)

      by SlashDev (627697)
      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...
  • Is this it? (Score:5, Insightful)

    by davek (18465) on Thursday July 02, 2009 @03:30PM (#28562707) Homepage Journal

    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? (Score:5, Insightful)

      by geoffspear (692508) on Thursday July 02, 2009 @03:35PM (#28562809) Homepage
      No, because parents will refuse to let their children get vaccinated because that would encourage them to have premarital sex.
    • Re:Is this it? (Score:5, Insightful)

      by BlueBoxSW.com (745855) on Thursday July 02, 2009 @03:38PM (#28562873) Homepage

      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? (Score:5, Insightful)

      by im_thatoneguy (819432) on Thursday July 02, 2009 @03:38PM (#28562877)

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

      • Influenza Vaccine (Score:2, Insightful)

        by Anonymous Coward

        The influenza vaccine works extremely well against the strain of flu it's developed for. The problem being that there's so many strains of flu, and they're constantly mutating.

        Course, that's also true of HIV. So I'm going to guess it's going to be more like the influenza vaccine.

      • Re:Is this it? (Score:4, Insightful)

        by Opportunist (166417) on Thursday July 02, 2009 @04:00PM (#28563281)

        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? (Score:5, Insightful)

        by rumblin'rabbit (711865) on Thursday July 02, 2009 @04:49PM (#28564107) Journal
        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? (Score:5, Informative)

      by dunezone (899268) on Thursday July 02, 2009 @03:43PM (#28562981) Journal
      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: (Score:2, Informative)

      by Anonymous Coward

      This is a phase I test.

      The huge one is phase III

      http://www.iavi.org/RESEARCH-DEVELOPMENT/DEVELOPMENT-CYCLE/Pages/review-process.aspx

      Other vaccines passed phase I and failed after that.

      These are good news because scientists doesn't start human trials if they don't feel good about the vaccine developed but it isn't the time to celebrate yet.

    • Re:Is this it? (Score:5, Informative)

      by Anonymous Coward on Thursday July 02, 2009 @06:13PM (#28565281)

      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?"

    • by h3llfish (663057)
      No, this is nothing to get excited about. It's not even newsworthy. Dozens of other potential vaccines have made a splash in the media, but ultimately proved ineffective. I really do hope that this is the one, but... call me when it WORKS.
  • by mofag (709856) on Thursday July 02, 2009 @03:33PM (#28562789)

    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: (Score:3, Informative)

      by Ian Alexander (997430)
      Geez, can't people even be bothered to read the summary anymore? From the summary:

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

      Presumably this is a therapeutic vaccine intended to equip the immune system to fight HIV before it trashes your immune system irreparably. I didn't bother to read the article (but I was able to finish the summary) so I wouldn't really know.

      • Re: (Score:3, Informative)

        by thesandtiger (819476)

        One of the studies we're doing in my lab is an intervention with (currently) HIV- youth who engage in frequent risk behaviors (most are sex workers, a little under a third are IV drug users, a very small portion just have risky sex because that's what they do). As part of the study, we do HIV testing every 3 months. We have an "expected" rate of conversion (obtained from other studies) and then we compare our actual rate of conversion to see whether our intervention is having an impact. While I'm no biostat

    • by TheRaven64 (641858) on Thursday July 02, 2009 @04:06PM (#28563397) Journal
      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: (Score:3, Informative)

      by bugnuts (94678)

      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?

      Wouldn't that also depend on how sleazy of a whore your wife is over those 10 years?

  • No Optimism on HIV (Score:3, Interesting)

    by reporter (666905) on Thursday July 02, 2009 @03:40PM (#28562905) Homepage
    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 [washingtonpost.com] 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.

    • by Yold (473518) on Thursday July 02, 2009 @03:55PM (#28563201)

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

      • Great idea. It worked for teenage pregnancy, it should work like a dream for a disease that you don't notice after 3 months when your belly starts to swell.

        • It may be unrealistic, but so is the first option presented, and the second option is wishful thinking for a miracle vaccination despite the rest of the post repudiating the possibility of vaccination (albeit using a new method, but based on a supposed immunity of certain European populations that actually only impacts a subset of all HIV infections).

      • by petrus4 (213815)

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

        a) Use condoms/spermicides etc.

        b) If you're going to be in more than a one night stand with someone, (which is preferable, from a disease point of view) then at least see if they'd be willing to get tested; especially if they've previously engaged in bisexual activity. It might not be politically correct to say it, but outside of the Third World, HIV is a primarily gay or bi disease. Call me a bigot for that as

        • by HTH NE1 (675604)

          e) Realise that abstinence will not kill you, and that consequently, contrary to popular perception, sex is actually a want, rather than a need.

          Colossus: HOW MANY NIGHTS A WEEK DO YOU REQUIRE SEX?
          Dr. Forbin: Every night.
          Colossus: NOT WANT. REQUIRE.
          Dr. Forbin: [looks sheepish] Four times.

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

    • Re: (Score:3, Informative)

      by TheMohel (143568)

      Unfortunately (OK, it's not unfortunate at all, actually), option #1 isn't just taboo, it's impossible in any human society. Even if we had a completely accurate test (which we certainly do NOT have), and even if you could somehow prevent all positive contacts from continuing their infectious behavior (and I'm not sure anything short of summary execution would be reliable), you'd still have leakers, avoiders, corruption, and resistance. Not even North Korea has managed to avoid HIV, although they're close,

    • by ae1294 (1547521)

      The only way to eradicate this virus is either

      You forgot one option. We can nuke the site from orbit as it's really the only way to be sure...It's DC after all...

    • by greymond (539980)

      um not that I don't agree with some of what you're saying but 3% of DC's population versus 3% of Uganda and/or Kenya's population is like comparing 3% of one apple to 3% of a barrel of apples...

    • When the article says "Some parts of Kenya" that means the good parts. The overall infection rate in 2003 was estimated at 6.7%. Uganda is the birthplace, as I recall, of the ABC strategy.

      This article makes it sound as if DC is as bad as "Africa" when it comes to AIDS. Unfortunately (for most of sub-Sahara Africa, not DC residents), this just isn't true.

      3% may be bad, but 3% with decent health care is a world away from the 15+% infection rate and poor health systems that some countries are dealing with.

  • Gambia's president claims he has cure for AIDS: http://www.msnbc.msn.com/id/17244005/ [msn.com]
    No need for a vaccine, people. When will people learn that science can't hold a candle to sympathetic magic?
    FYI, I am not a doctor, and this is not medical advice. Ask your Doctor if Gambia's President's magic is right for you.
    • It works! Sure, the patient dies in the process because he develops AIDS and croaks, but the virus dies as well. Sympathetic, ya know...

  • by Animats (122034) on Thursday July 02, 2009 @03:59PM (#28563277) Homepage

    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.

    • by TheMohel (143568) on Thursday July 02, 2009 @04:10PM (#28563473) Homepage

      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.

      • by Mortiss (812218)

        Are there any links or details actually available regarding the nature of this vaccine? SAV001-H doesn't show up on PubMed.

  • If I ever learned anything from watching South Park, it's that any successful HIV vaccine has to contain large amounts of raw money! ;-)

    All kidding aside, this is wonderful. I hope this gets to save a lot of people very soon.

    And to be pedantic, since it's a vaccine, I guess it works against the Human Immunodeficiency Virus, not the Acquired Immune Deficiency Syndrome.

  • A vaccine is usually a weaker version of the original virus, right? If HIV is spread sexually, does the vaccine spread sexually as well? This really puts a wrench into sex education.
    • Re: (Score:3, Informative)

      A vaccine is usually a weaker version of the original virus, right?

      If HIV is spread sexually, does the vaccine spread sexually as well? This really puts a wrench into sex education.

      No, a vaccine is usually a DISABLED version of the original virus - one that has the protein coat that the immune system would use to recognize and create antibodies for, but has the part that creates copies of the virus disabled so it can't make any more to overwhelm the host or to spread.

  • Hicks (Score:4, Funny)

    by WilyCoder (736280) on Thursday July 02, 2009 @04:16PM (#28563599)

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

    -Bill Hicks

    • Re: (Score:3, Insightful)

      by TheRaven64 (641858)
      Right until people realise that there still isn't a cure or vaccine for herpes...
  • I want to know what crazy bastards are volunteering for Phase II and Phase III testing.
  • I mean, how are they going to really test that it works? Because, I am sure there are just tons of people out there that want to be exposed to HIV just to see if the vaccine they took actually keeps you from getting a virus that WILL kill you.
    • Re: (Score:3, Insightful)

      by Tom DBA (607149)

      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.

  • by mqduck (232646)

    Great! Now we can start fucking again (so long as birth control is used) without any concern about anything bad happening ever again, right?

    RIGHT??

  • by jameskojiro (705701) on Thursday July 02, 2009 @08:24PM (#28566645) Journal

    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.

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