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First Phase of AIDS Vaccine Trials Successful 554

Posted by ScuttleMonkey
from the baby-steps dept.
rbarreira writes "Xinhua online is reporting on the success of the first trial phase of an AIDS vaccine, which was started on March 2005. From the article: '"Forty-nine healthy people who received the injection showed no severe adverse reactions after 180 days, proving the vaccine was safe," said Zhang Wei, head of the pharmaceutical registration department of the SFDA. "The recipients appeared immune to the HIV-1 virus 15 days after the injection, indicating the vaccine worked well in stimulating the body's immunity," he told the press conference.' After the results are further analyzed, 800 more voluntaries may be needed for the second and third phases of the vaccine's trial."
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First Phase of AIDS Vaccine Trials Successful

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  • by jeremymiles (725644) * on Sunday August 20, 2006 @04:11PM (#15945060) Homepage Journal
    This is the first trial, which means it's a phase 1 trial [wikipedia.org]. Phase 1 trials are not designed to demonstrate efficacy, they are to demonstrate safety. Whether it works or not comes next.
  • Re:Duck and Cover (Score:4, Informative)

    by Anonymous Coward on Sunday August 20, 2006 @04:13PM (#15945068)

    The Evidence That HIV Causes AIDS [nih.gov]

    HTH. IHBT. HAND.

  • Re:HIV (Score:3, Informative)

    by AgentFade2Black (968245) <<tetra.assassin> <at> <gmail.com>> on Sunday August 20, 2006 @04:17PM (#15945092)
    Didn't you read the article? The HIV-1 cells they injected were genetically engineered not to have the ill effects of HIV/AIDS. So they were meant to, in all actuality, be like the HIV/AIDS of deadly reputation, but without the threat of lawsuits waiting in the wings.
     
    Any questions?
  • by albalbo (33890) on Sunday August 20, 2006 @04:18PM (#15945095) Homepage
    Well, I seriously doubt that they were telling these people to go out, sleep around and try to get pozzed up - that would be mildly unethical, I would think.

    I would suggest they probably tried introducing HIV into a blood sample of the patient, and tried to see how successful HIV was in reproducing. If it can reproduce well in "normal" blood, but badly in the blood of the patient, that's a reasonable indication that they're immune.
  • Re:Duck and Cover (Score:3, Informative)

    by debilo (612116) on Sunday August 20, 2006 @04:19PM (#15945098)
    We know that HIV is the virus which mutates into AIDS. Proof enough?

    No, because, well, you know, viruses cause diseases, they don't mutate into diseases. Even if we're laymen and not scientists, we should choose our words more carefully so as to not spread bullshit and misconceptions.
  • by Kitten Killer (766858) on Sunday August 20, 2006 @04:21PM (#15945106)
    That's why this is a Phase I trial.

    Drug trials go through three phases, the first of which consists of a very small number of subjects. It's essentially the first time the drug is used on humans and to see it doesn't have immediate, obvious side effects not observed in animal trials. The 2nd and 3rd phases continue to monitor safety while attempting to determine the efficacy of the drug.

    Keep in mind, that a lot of the recalled drugs, such as the COX2 inhibitors like Vioxx, don't show negative side effects until your trial goes into hundreds or thousands of subjects. And even then, the drugs are continually monitored after their release to look for effects that might be present only in 0.1% even or 0.001% of the population
  • Re:HIV (Score:5, Informative)

    by venicebeach (702856) on Sunday August 20, 2006 @04:25PM (#15945121) Homepage Journal
    from TFA:
    Some recipients' cells and body fluids in the combined group appeared immune to the HIV-1 virus, said Sang Guowei.
    Not sure exactly what this means, but it seems like they extracted body fluids and tried to infect with HIV in-vitro.
  • Re:But I thought... (Score:5, Informative)

    by Pedrito (94783) on Sunday August 20, 2006 @04:27PM (#15945128) Homepage
    That this was a slow gestating virus that could lie dormant for years before going into reproductive mode. How does 180 days of "apparent" immunity (with no control group?!?) make a valid experiment?

    Actually, that's not really the case. HIV actually replicates very quickly after infection. Even though one may not show symptoms for many years, that's unusual. Most people develop the first symptoms within weeks of getting the virus. But with or without symptoms, signs of the virus can be found very quickly, particularly in the lymphatic system.

    Do not confuse HIV infection and symptoms with AIDS. One isn't considered to have AIDS until their T-Cell count falls below 200 cells per uL. This is usually the point where the person starts developing the kinds of diseases that normally don't affect healthy people. Before that point, you still has a tendency to get sick from a number of more common illnesses.
  • Re:Duck and Cover (Score:3, Informative)

    by daniil (775990) <evilbj8rn@hotmail.com> on Sunday August 20, 2006 @04:31PM (#15945139) Journal

    (Don't forget to mod me down - I said something bad)

    No. You just said something that most intelligent people consider stupid, knowing that most Slashdotters (who, in all honesty, are not really as smart as they think they are) will consider it stupid as well. That's why you got modded down.

  • by CharonX (522492) on Sunday August 20, 2006 @04:47PM (#15945191) Journal
    First of all, this is only Phase 1 of 3.
    Phase 1 in clinical trials is meant to make sure the drug in general is "safe" and to determine the maximum safe dosage.
    Testing if the drug really works as expected, how effective it is etc. is done in Phases 2 and 3 with a much larger group, in double-blind experiments.
    Still, before Phase 1 there were many other experiments - i.e. test with animals, computer simulations etc. - which must have shown some promise otherwise they wouldn't spend money on the human trials.
  • by ichigo 2.0 (900288) on Sunday August 20, 2006 @04:48PM (#15945197)
    Take a blood sample and see if there's HIV antibodies. Don't know about other strains, but hopefully they're similar enough so the vaccine also gives immunity against them.
  • Re:HIV test (Score:5, Informative)

    by Snootch (453246) on Sunday August 20, 2006 @05:14PM (#15945277)
    However, a lot of tests for viral infection is based on the presence of the antibodies in blood. So, if the person has been immunized using the vaccine, the person will have those antibodies in blood, and it becomes difficult to tell whether the antibodies came as a result of vaccination or infection.

    There are quite a few different tests for HIV - you're right, the primary test is antibody-related (a quick-n-dirty relative of the Western blot, followed up by an actual high-precision blot if the initial screening turns up positive), but there are alternatives based on testing for the actual genes.

    In a nutshell, the sample is combined with a set of enzymes and primers that will replicate only a specific stretch of DNA (in this case, the HIV genome). If there is HIV in the blood, you'll end up with a lot of HIV DNA around the place, which you can then test for with fluorescent probes or something similar.

    This type of method would not be affected by anything your immune system does, as it tests directly for the presence of the virus.

    There's a list of the available tests, and a bunch of other information - mostly aimed at patients - here [hivtest.org].
  • Re:Booster shots? (Score:2, Informative)

    by tacarat (696339) on Sunday August 20, 2006 @05:52PM (#15945417) Journal
    Hate to burst your bubble, but most people I know don't use condoms to avoid disease, they use them to avoid pregnancy. Condoms only reduce the transmission of a subset of STDs. Crabs and herpes are just a couple of examples that condoms won't block.

    No bubble burst, and you're right about the STD transmission. I'm still fairly sure that rates on the applicable (condom blocked) STD rates may go up, even if it's not a skyrocket. Pregnancy isn't an issue for gay men, nor is it an issue if the female partner in a heterosexual relationship is on another form of contraceptive. Exposure to something by either partner puts the other at risk. STD safety and awareness isn't really hyped in US media outlets aside from HIV. When's the last time they held a fund raiser or march for people with syphilus or genital warts?
  • Re:Umm ... (Score:2, Informative)

    by yndrd1984 (730475) on Sunday August 20, 2006 @05:56PM (#15945443)
    Why is it important to develop a way to allow people who have little regard for their own health to remain healthy?
    For the same reason we developed seatbelts, bulletproof vests and the cooking of meat. Sure, people can avoid being in motor vehicles, professions where they're likely to get shot at in and not eat pork, but that curtails their lives tremendously.

    On the other hand, what kind of idiot argues that a safety measure shouldn't be developed?. The "let 'em die" attitude is rather uncivilized.

  • by daeg (828071) on Sunday August 20, 2006 @06:26PM (#15945545)
    Or the elderly community. 27% of those in the US living with HIV are over 50 and they are the fastest growing group of new HIV cases [ http://www.cbsnews.com/stories/2006/08/18/eveningn ews/main1913646.shtml [cbsnews.com] ]
  • by gnarlin (696263) on Sunday August 20, 2006 @06:52PM (#15945628) Homepage Journal
    I'm a lesbian. I also have an immune system/skin condition called psoriasis. I've spent the last eight years fighting with different doctors for the chance to try new treatments when they become available.
    Perhaps I could offer you some advice.
    The reason for the doctors hesitation to prescribe you the experimental medicin is due to their danger of being liable for the side effects of those drugs that have not been officially aproved by the FDA, even if you acknowledge the danger of said effects.


    Go talk to a lawyer and have him/her/it draft a letter of legal absolution from liability which you can offer the reluctant doctors in exchange for their cooperation.
    Basically, they are just covering their own asses when they are denying you those drugs. Good luck.

    Also, I think that the slashdotting community would probably not be adverse to you writing down some of your romantic exploits. In fact that's probably what the slashdot's journal was made for: Hot lesbian love ;-)

  • by Kitten Killer (766858) on Sunday August 20, 2006 @08:53PM (#15945958)
    They used DNA because RNA is not suitable here. RNA is highly unstable, even in the lab.

    Remember that HIV is a RETROvirus. It retro-transcribes itself back into DNA (and thus allowing for genomic integration). So, in a way, HIV does have DNA.

    As for the "cells" thing, this was told to Xinhua news agency, which means the conversation was likely in Chinese, and somewhere things got lost in translation.
  • Re:Duck and Cover (Score:3, Informative)

    by ElephanTS (624421) on Sunday August 20, 2006 @08:55PM (#15945965)
    I know this is an odd story. AIDS is a very odd story. I clipped this from this website:

    http://aliveandwell.org/ [aliveandwell.org]



    According to the 1999 World Health Organization (WHO) report, the total number of actual diagnosed AIDS cases on the African continent is about equal to the total for AIDS in America even though Africa, with its 650 million people, has more than two times the population of the USA. (61) Africa is often cited as a worst case example of what could happen in America despite figures that demonstrate that 99.5% of Africans do not have AIDS, and among Africans who test HIV positive, 97% do not have AIDS. (62)

    Unlike in the United States, AIDS in Africa may be diagnosed based on four clinical symptoms -- fever, involuntary loss of 10% of normal body weight, persistent cough, and diarrhea -- and HIV tests are not required. (63) The four clinical AIDS symptoms are identical to those associated with conditions that run rampant on the African continent such as malaria, tuberculosis, parasitic infections, the effects of malnutrition, and unsanitary drinking and bathing water. These symptoms are the result of poverty and other problems that have troubled Africa and other developing areas of the world for many decades.

    The idea that AIDS originated in Africa remains popular although there has never been scientific or epidemiological evidence to substantiate this notion. News reports suggesting that HIV began in Africa as Simian Immunodeficiency Virus (SIV) are based on elaborate speculation about species-jumping viruses rather than reliable evidence.

    SIV induces only flu like symptoms in some experimental laboratory monkeys and does not cause any of the 29 official AIDS-defining illnesses. Unlike HIV infection which is said to cause illness only years after exposure and despite the presence of protective antibodies, SIV will cause illness within days of infection or not at all, and wild monkeys retain SIV antibodies throughout their lives without ever becoming ill. Only monkeys in unnatural circumstances -- lab animals with undeveloped immune systems who are injected with large quantities of SIV -- become ill. (65)


  • by d723 (891634) on Monday August 21, 2006 @01:01AM (#15946639) Homepage Journal

    I'm a study patient in a Phase II trial of an HIV vaccine and I personally know of at least one other vaccine in Phase II. This web page [ucsf.edu] seems to confirm that. The Merck Gag-Pol-Nef study started Phase II testing in January 2005 [hvtn.org] and has positive results. I thought I remembered my study doctor saying is was going to phase three, article on the current HIV vaccine landscape [thebody.com] indicated two studies in Phase III. Phase III is where they get 800 people of high risk and give half the vaccine and half placebo and see if the vaccine group stays uninfected.

    Either way, there have been quite a number of Phase I trials.

    I also question this quote:

    The recipients appeared immune to the HIV-1 virus 15 days after the injection,

    How did they determine that? Certainly they didn't infect these people. I think this whole article is just some China-PR person's belch.

  • Re:Duck and Cover (Score:1, Informative)

    by Anonymous Coward on Monday August 21, 2006 @01:02AM (#15946643)
    for the original parent poster: people do know how the infection happens.
    1) person aquires a couple hundred virons in their bloodstream, all of which have a plasma membrane envelope surrounding viron
    2) special proteins in this envelope enable the it to merge with the plasma membrane of CD4 T Lymphoctyes (aka. t helper cells)
    3) the reverse transcriptase that was packaged with the RNA inside the viron goes to work, transcribing DNA from the RNA of the AIDS virus (reverse transcriptase, et. al.)
    4) endonucleases and other associate proteins (which also come in the viral package) insert the viral DNA into the host DNA.
    5) Natural host protein manufacturing processes are directed by other viral mRNA sequences to produce huge quantities of both the viral DNA segment and the viral proteins.
    6) new virons are packaged and then Pushed out of the plasma membrane of the CD4 cell. This reforms the virus complete with protein bearing envelope ready for infecting another CD4 cell
    7) repeat x 1,000,000+
    8) original CD4 cell runs out of spare plasma membrane, ruptures, and dies. (think of a firecracker in an orange)
    9) A whole bunch more CD4 cells become infected, some are killed others the virus remains dormant (hence the dip in CD4 counts immediately post infection followed by their resurgance.
    10) after X amount of time, the viral machinery reactivates and kills the CD4 cells, saturating the host with viral particles
    11) Host loses cell-mediated immunity
    12) Chaos ensues (AIDS)
    13) By the time the patient succumbs to a secondary infection, the CD4 cells have been so depleted, that there aren't any left to produce any virus, so sometimes you see low viral loads at the time of death. Makes sense eh?

    Just because You don't understand a thing doesn't mean that Noone understands a thing. I just hate all the tin-foil conspiricists. Go to Africa, watch villages die, come home and take your damn meds so we don't get even more resistant strains of HIV than we already have.

    If you would like to call into question if we can really 'Know' any of these steps, you are calling into question the entirity of modern medical science. If you really want to know, take an immunology class (and the prerequisite basic biology class) at your local college. These will hopefully prove to you beyond a doubt the usefullness of the biochemical tools used to come to these conclusions regarding this retrovirus's lifecycle.

    Also, please note that watson & crick stole the original data for their DNA research. Do you not belive that DNA is a double helix? Because that was based on stolen evidence too. Of course, they later reproved it a hojillion times, but the same thing has happened with HIV->AIDS.

    Regarding those original quotes, most are grossly out of context and the few that are factual, I'm sure the original persons would not be happy to see their words twisted so badly.
  • by NF6X (725054) on Monday August 21, 2006 @02:50AM (#15946896) Homepage
    Shads wrote: You're 100% healthy, find a mythical 10 shot revolver, load 9 chambers with blanks and one with a real bullet, give the chamber a spin and put it to your head and pull the trigger.

    Sigh. Following those directions would likely be fatal whether the live cartridge or one of the blanks landed under the hammer. For example, actor Jon-Erik Hexum accidentally killed himself by firing a blank against his head [wikipedia.org] with a prop gun on the set of some crappy TV show in the 80's.

  • by yfarren (159985) <yossi.farvi@com> on Monday August 21, 2006 @10:26AM (#15948356) Homepage
    I wish mods would check links, before saying "informative". How about "misleading" or "lying". Oh, I know, he only inserted one itty bitty little word. Only 3 letters long.

    Yea, that word was "new". What the article he is quoting SAYS is that in the USA, 27% of people with HIV are over 50. It ALSO says that some people over 50 are getting aids. No-where does it say that 27% of people with aids are GETTING it when they are over 50. To say then, that it is the largest growing sector of the population just means that people who got it in their 30's, in the 80's, are now still alive, and are turning 50.

    Informative? Please. Try "deceitful".

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