Another HIV vaccine fails, US study halted

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    Apr 25, 2013 8:38 PM GMT
    "Bad news in the fight against the AIDS virus: The government is halting a large U.S. study of a possible HIV vaccine because the experimental shots aren't preventing infection."

    http://vitals.nbcnews.com/_news/2013/04/25/17914860-another-hiv-vaccine-fails-us-study-halted?lite
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    Apr 27, 2013 4:53 PM GMT
    *bump*
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    Apr 28, 2013 4:54 AM GMT
    I am actually part of this HIV vaccine trial, I am one of very few people who was unblinded before the press release. I'm really disappointed that it didn't work, but we can learn from this!
  • helium

    Posts: 378

    Apr 28, 2013 3:23 PM GMT
    I think that the vaccine failed because people who are in the study thought that they should do some crazy shit. I had a friend did it.
  • calibro

    Posts: 8888

    Apr 28, 2013 3:45 PM GMT
    helium saidI think that the vaccine failed because people who are in the study thought that they should do some crazy shit. I had a friend did it.


    if the vaccine worked, your crazy friend could have done all he wanted to it. it failed because it failed.
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    Apr 28, 2013 7:15 PM GMT
    helium saidI think that the vaccine failed because people who are in the study thought that they should do some crazy shit. I had a friend did it.


    That's the wrong idea, the vaccine was double blind, I was one of very few who actually knew he got a vaccine. The people who made stupid choices were probably making them with or without the vaccine.
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    Apr 28, 2013 7:19 PM GMT
    EmuAlexandr saidI am actually part of this HIV vaccine trial, I am one of very few people who was unblinded before the press release. I'm really disappointed that it didn't work, but we can learn from this!

    Naturally I'm very sorry to hear of this failure. I also want to thank you for having taken part in the study. It sounds like you approached it in a responsible & ethical manner, and it's guys like you who will eventually be part of ultimately finding the vaccine or even cure for HIV. My greatest admiration for you, and the others involved. icon_biggrin.gif
  • musclmed

    Posts: 3280

    Apr 28, 2013 7:24 PM GMT
    ART_DECO said"Bad news in the fight against the AIDS virus: The government is halting a large U.S. study of a possible HIV vaccine because the experimental shots aren't preventing infection."

    http://vitals.nbcnews.com/_news/2013/04/25/17914860-another-hiv-vaccine-fails-us-study-halted?lite


    this article is wrong it was NOT the governement.

    The study was halted by the administrators of the study. The FDA had no role in the decision to stop the trial.

    There was no benefit seen in the few patient who received the vaccine.

    A safety review this week found that slightly more volunteers who had received the vaccine later became infected with HIV. It's not clear why.

    there was no statistical difference between the two groups. There is not enough difference between the groups to draw a conclusion that it was harmful. But there is enough to say it likely will have no benefit.

    the group of men involved were high risk men.
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    Apr 28, 2013 9:28 PM GMT
    The OFFICAL email from the researchers :


    We have some important new information from the HVTN 505 study to share with you.
    We are going to stop further injections in the HVTN 505 study because the vaccine did not show efficacy. This means it did not work to prevent HIV infection nor reduce the amount of virus (viral load) in the blood among people in the study who became infected with HIV. Study visits will continue, however, and following up with us will be very important.
    What happened?
    As you know, the study tested a combination of two HIV vaccines: three injections of a DNA-based vaccine designed to prime the immune system, followed by one injection with a weakened adenovirus type 5 (the booster vaccine). The study was designed to look at two main questions:

    • Do the vaccines prevent HIV infection?

    • Do the vaccines reduce the amount of HIV in a person’s body (the HIV viral load) in those who got the vaccine and later developed HIV infection?
    Like every study which tests whether or not an experimental drug or vaccine will work, our study has been closely monitored by a group of experts called a Data Safety Monitoring Board (DSMB). This group of experts regularly reviews study information to make sure that the study remains safe for participants and is on track to answer its main research questions. The DSMB can see who is getting the vaccines and who is getting the placebo.
    At their regularly scheduled meeting on April 22, 2013, the HVTN 505 DSMB looked at the data from the study and compared the results in people who got the vaccine to results in people who did not get the vaccine (the placebo group). The results showed that the vaccine did not prevent HIV infection. The vaccine also did not reduce the viral load in those who became infected with HIV.
    Based on this information, the DSMB recommended that for participants who have not yet received all their vaccinations, further vaccinations should be stopped. The study sponsors and the team agreed with these recommendations.
    Other important findings:
    At the time of the DSMB meeting, there were somewhat more new HIV infections among participants who received the vaccine than those who received the placebo after the full vaccination series: 21 infections in the placebo group compared to 27 in the vaccine group. But this difference was not significant in a statistical analysis. However, because of results from earlier studies with type 5 adenovirus vaccine (like the Step Study we told you about when you joined the 505 study) we will want to continue following you closely in the study to do HIV testing, and monitor your body’s response to the vaccinations you have already gotten.
    We will be in touch with you about the details of your study visits and plans for letting you know whether you received the placebo or the vaccine (a process called unblinding). This information will help you decide, with input from the study clinicians and your health care provider, how best to protect yourself from acquiring HIV.
    Knowing this new information may change how you feel about staying in the study. If you decide to leave the study, your decision will not affect the care you receive at this health care institution. But your participation continues to be very important. We encourage you to remain in the study so we can continue to learn as much as possible in our efforts to develop a protective HIV vaccine.
    Summary

    • The DSMB found that the study vaccine did not prevent HIV infections or lower the amount of HIV in people who got infected.

    • There were somewhat more new infections in the vaccine compared to placebo group, but the difference was not significant when the numbers were analyzed by a statistician.

    • We are stopping further injections in the HVTN 505 study.

    • We would like you to continue with study visits for HIV testing and to monitor your well-being.

    • We will get back to you soon about additional plans for this study and will let you know the details of unblinding (a process where we tell you if you got the vaccine or placebo).

    • We will continue to tell you any news that affects your health, well-being or decision to be in the study.
    We were able to get answers to the two main research questions, and your participation in the study helped us do this. Every study is critically important in guiding future vaccine development.
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    Apr 28, 2013 9:39 PM GMT
    musclmed said
    ART_DECO said"Bad news in the fight against the AIDS virus: The government is halting a large U.S. study of a possible HIV vaccine because the experimental shots aren't preventing infection."

    http://vitals.nbcnews.com/_news/2013/04/25/17914860-another-hiv-vaccine-fails-us-study-halted?lite


    this article is wrong it was NOT the governement.

    The study was halted by the administrators of the study. The FDA had no role in the decision to stop the trial.

    Could you please provide more information about this? The article mentioned the NIH (National Institutes of Health) as withdrawing the vaccine, not the FDA that wasn't mentioned, and which would not have the lead in such a study.

    I understand these working relationships can be complex and convoluted, but I'm assuming the involvement of the NIH is what prompted the article's authors to say that "the government" is halting the study.

    The NIH is part of the US Dept. of Health & Human Services (HHS).

    http://nih.gov
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    Apr 29, 2013 1:41 AM GMT
    Here is the press release from the NIH and more specific of the information -

    http://www.niaid.nih.gov/news/newsreleases/2013/Pages/HVTN505April2013.aspx

    Please note there are several strategies in terms of HIV vaccine - not just one approach. The live vector (adenovirus carrier) is just one approach which failed, but these also failed on the VAX0003 and VAX0004 (Asian study) previously.

    Types of Experimental HIV Vaccines:
    peptide vaccine: made of tiny pieces of proteins from the HIV virus.
    recombinant subunit protein vaccine: made of bigger pieces of proteins that are on the surface of the HIV virus. Examples of a recombinant subunit protein are gp120, gp140, or gp160 produced by genetic engineering.
    live vector vaccine: non-HIV viruses engineered to carry genes encoding HIV proteins. The genes are inserted into another vector, which carries them into the body's cells. The genes in turn produce proteins that are normally found on the surface of the HIV virus. This type of vaccine most resembles the HIV virus but is not harmful. Many vaccines used today, like the smallpox vaccine, use this approach.
    DNA vaccine: uses copies of a small number of HIV genes which are inserted into pieces of DNA called plasmids. The HIV genes will produce proteins very similar to the ones from real HIV.
    vaccine combination: uses any two vaccines, one after another, to create a stronger immune response. Often referred to as "prime-boost strategy."
    virus-like particle vaccine (pseudovirion vaccine): a non-infectious HIV look-alike that has one or more, but not all, HIV proteins.

    This past semester I had to do a clinical research project. My project involved the HIV vaccine. I believe that the Recombinant approach is the better way to go. The reason being is that the HIV virus has a protein receptor which our immune system also has, it needs this 'anchor' to invade the cell membrane. However, we know already that some individuals in their immune system do not have these receptors -CCR5 or CXCR4. Therefore, if we block the protein synthesis in the immune system through the use of gene therapy the HIV virus can not anchor and replicate. However, CCR5 deficiency only offers some protection since other strains of HIV do not have the CCR5 protein receptor but CXCR4. This is why regional HIV vaccines based on the region will be the better approach. We are closer to understanding the virus and its mechanism, and its not a simple approach.

    I know it can be discouraging with the water down media when they do not really present the facts correctly since they are in the business of selling a quick story.

    Here is also the link to the HIV vaccine trials network.

    http://www.hvtn.org/index.html



  • musclmed

    Posts: 3280

    May 02, 2013 4:56 AM GMT
    ART_DECO said
    musclmed said
    ART_DECO said"Bad news in the fight against the AIDS virus: The government is halting a large U.S. study of a possible HIV vaccine because the experimental shots aren't preventing infection."

    http://vitals.nbcnews.com/_news/2013/04/25/17914860-another-hiv-vaccine-fails-us-study-halted?lite


    this article is wrong it was NOT the governement.

    The study was halted by the administrators of the study. The FDA had no role in the decision to stop the trial.

    Could you please provide more information about this? The article mentioned the NIH (National Institutes of Health) as withdrawing the vaccine, not the FDA that wasn't mentioned, and which would not have the lead in such a study.

    I understand these working relationships can be complex and convoluted, but I'm assuming the involvement of the NIH is what prompted the article's authors to say that "the government" is halting the study.

    The NIH is part of the US Dept. of Health & Human Services (HHS).

    http://nih.gov


    When the FDA stops a study that is part of their governement oversite.

    NIH funded the study in part, but is not "the government" . The board that made the decision were investigators involved in the study.

    The FDA has jurisdiction over all human trials in the United States.

    "the government " suggest someone had to intervene. What happened here happens in many clinical trials when a investigation board finds that the study needs early termination. This is when it is statistically clear the treatment is unlikely to be beneficial.