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VaxGen's AidsVax: has trial's search for "barebackers" slanted vaccine substudy?

The failure of AidsVax to prevent infection with HIV - in clinical trial results published in 2003 - triggered an intense debate about the controversial product and its manufacturer, VaxGen Inc of Brisbane, California. Mail to this website, maintained by Brian Deer, shows that existing material on a VaxGen-AidsVax index is read by significant numbers. This page seeks to further inform the discussion


The federal prosecution of VaxGen vice-president Dr William Heyward following Brian Deer's 1999 Sunday Times investigation, The VaxGen Experiment, calls attention to the project for which Heyward helped secure VaxGen $8m from the Centers for Disease Control and Prevention. The core of this work is what is believed to be the only significant controlled (comparative) study of the behavior of participants in an HIV vaccine trial (see CDC news release at this site). On February 24 2003, it was announced that the trial had failed to show efficacy.

As the trial progressed, reports surfaced that the sponsors were selectively recruiting men "who liked risky sex", followed by the discovery that "barebackers" were being actively solicited. These are men who, as a matter of established practice, choose not to use condoms. Although this might seem a good group in which to test AidsVax, such intensive recruitment poses risks to the CDC study. The study aimed to see whether persons participating in the trial were likely to take more risks on the expectation that they may be protected by AidsVax. But barebackers were already taking all the risks it was possible to foresee - making a "deterioration" in their behavior in terms of condom use impossible. Those who responded to counseling could only respond positively. Comparing their behavior with a more general population of men who have sex with men would potentially skew the comparisons Heyward helped initiate. If so, the result could appear more favorable to VaxGen than is warranted: helping to contradict uncontrolled studies which suggest that persons who believe they may be protected by vaccination become less cautious in their sexual behavior.

On March 31 2003, Dr Phillip Berman, the inventor of AidsVax presented data, including a risk behavior chart, confirming a particularly strong presence of barebackers in the trial.

Below is promotional material extracted (after the trial closed to new recruits) from a website for men who choose not to use condoms: barebackjack.com (graphics excluded). It includes an exploratory invitation for AidsVax trial participants to meet and have sex together. The formal disclaimer for this potential event is suggestive of VaxGen collaboration in other aspects of barebackjack's AidsVax recruitment initiative. A similar invitation can be found on the site in November 1999.

The material is followed here by the full html text for a no-quibble recruitment page posted on barebackjack.com from April 1999 (extracted by Brian Deer from the www internet archive). A header meta tag indicates that the page for both texts was created in September 1998: when the AidsVax trial was launched. According to barebackjack.com, its site received 75,000 hits in its first seven months of operation. A counter on the site in November 1999 indicates visitors to total 894,018 as of that date.

At all times during the trial, barebackjack maintained hyperlinks to vaxgen.com.


A Very Important HIV Vaccine Trial Program


VagGen, a medical research and development company, is currently conducting trials in the cities below for a new and promising vaccine against HIV. The study is now closed in the United States. No new volunteers are being accepted at this time. However, for those involved in the program and those interested in its progress, this page will keep you informed as to developments and findings of the study group.

HOW IT WORKS:

This is a Phase III Trial.

Participants in the study were first tested in order to determine that they do not already carry antibodies to the HIV-1 virus.

Following a negative test result, they were given the first in the series of "vaccinations" (one out of three participants are being administered a placebo) with a follow-up assessment two weeks later to determine the vaccine's effects / side effects.

30 days from their first vaccination, they received another treatment, then others are being administered at six-month intervals covering the 3-year and 6 month period. Two weeks after each vaccination, participants are required to return for a follow-up assessment so the study can monitor their results.

This vaccine consists of a protein coat which replicates the benign outer structure of the HIV virus and does NOT contain living organic material from the virus. The purpose is to stimulate antibodies in the recipients' immune systems and measure the vaccine's efficiency without exposing the test subjects to the actual virus.

PEOPLE RECEIVING THE VACCINE OR THE PLACEBO
CANNOT GET HIV FROM THIS VACCINE.


For complete information on this breakthrough study,

CLICK HERE

(all information above has been compiled from the VaxGen site and printed material)


SOME NEW INFORMATION:

VaxGen has determined that the AIDSVAX vaccine does NOT increase the recipient's chances of receiving a "false positive" result during a standard HIV test. There had originally been an idea that test subjects might be more prone to testing falsely positive on the Western Blot test, but it has been determined that this is not the case. While the possibility still exists that a false positive reading may occur, the chances are no greater of this happeninig to volunteers than to persons not receiving either the vaccine or the placebo.

If you are on the study, some changes have occurred to the program which you will be asked to approve if you wish to continue:

  • The study has been extended to include Europe.
  • The study is to include up to 5,300 volunteers worldwide.
  • The number of scheduled visits has increased to 17 over 36-1/2 mos.
  • There will be at least 9 HIV-1 tests during the study.
  • If a volunteer should test HIV-positive during the study, he will be asked to return 1 month later, then every 4 months for a total of 24 months for follow-up.
  • The amount of blood drawn has increased during certain months (month 1, 2, 4, 8, and 16) to 15 tubes per month.
  • At clinic visits during months 12, 20, and 24, 10 tubes will be collected per month.
  • If the vaccine is found to be effective and you have received the placebo, you may be offered the full course of vaccine at no cost to you, depending on its availability.
  • If you live in a state which does not require all cases of HIV infection to be reported (Arizona is NOT one of these states), the US Federal government has authorized Certificates of Confidentiality to protect your anonymity. Ask your study coordinator to provide you with one.

  • There are other conditions and items you will be required to approve should you wish to continue, mostly having to do with "social harm" (public negative reactions to disclosure of your participation in the study), changes in wording in the VaxGen consent form, etc. Be prepared to go through the consent form and initial the changes on your next clinic visit.


    GOT ONE OF THESE?

    Any AIDSVAX participants interested in doing a weekend hideaway? This would be a private endeavor, and is not sponsored nor endorsed by VaxGen or its agents or representatives.
    Send an e-mail for more details.


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    CLICK HERE

    Vaxgen AIDSvax
    The first anti-AIDS vaccine to win attention from the FDA is now entering the final stages of its Phase III trial. If you're interested in learning more about the AIDSvax vaccine and its future applications, take a visit to their site.
    Information

    HTML TEXT OF PAGE FROM 1999:


    <html>

    <head>
    <meta http-equiv="PICS-Label"
    content='(PICS-1.0 "http://www.classify.org/
    safesurf/" l on "1998.09.30T21:37+0700 r (SS~~000 9 SS~~002 2 SS~~003 2 SS~
    ~004 2 SS~~006 2 SS~~009 2)'>
    <meta http-equiv="Content-Type"
    content="text/html; charset=iso-8859-1">
    <meta name="GENERATOR" content="Microsoft FrontPage Express 2.0">
    <title>VAXGEN ~ Vaccine Trials against HIV for HIV-Negative men</title>
    <base href="http://www.barebackjack.com/vaxgen.html">
    </head>

    <body background="redribbon.jpg">
    <STYLE TYPE="TEXT/CSS">
    <p align="center">H1{color:#00004F; font-size:46pt;
    font-family:arial black} H2{color:#00004F; font-size:30pt;
    font-family:times new roman} H3{color:#67006A; font-size:12pt;
    font-family:arial} H4{color:#003B56; font-size:12pt;
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    P{color:#003B56; font-size:10pt; font-family:century schoolbook} </STYLE>
    </p>

    <h1 align="center">VAXGEN <br>
    </h1>

    <h3 align="center">HIV Vaccine Trial Program <br>
    </h3>

    <hr>

    <p align="center"><br>
    <br>
    If you are an HIV-Negative man and would like to participate in <br>
    a volunteer program for the new FDA approved trial vaccine
    against <br>
    HIV called AIDSVAX by VaxGen, please refer to the map below to
    see <br>
    if there is a testing site near you. <br>
    <br>
    <img src="vaxgen_map.jpg"> <br>
    </p>

    <h3 align="center">SOME REQUIREMENTS YOU MUST MEET: You MUST be
    HIV-Negative You must be between 18 and 60 years old You must be
    in a high-risk group for <i>sexual</i> HIV transmission <br>
    (as barebackers, we are) You must be able to commit to the test
    program for 3 years. <br>
    <br>
    HOW IT WORKS: <br>
    You will initially be tested in order to be certain you do not <br>
    already have the HIV-1 virus. <br>
    <br>
    Following a negative test result, you will be given the first <br>
    in the series of &quot;vaccinations&quot; (one out of three
    participants <br>
    will be administered a placebo) with a follow-up assessment <br>
    two weeks later to determine the vaccine's effects / side
    effects. <br>
    <br>
    30 days from your first vaccination, you will receive <br>
    another treatment, then others will be administered at <br>
    six-month intervals covering the 3-year period. <br>
    Two weeks after each vaccination, you will be required <br>
    to return for a follow-up assessment so the study can <br>
    monitor your results. <br>
    </h3>

    <hr>

    <p align="center"><br>
    For complete information on this study, <br>
    <br>
    CLICK HERE <br>
    <br>
    (all information on this page has been taken from the VaxGen
    site) <br>
    <br>
    </p>

    <hr color="#FF0000">

    <p align="center"><br>
    <br>
    TO GO BACK TO JACK'S PLAYROOM<br>
    <a href="playroom.html"><br>
    </a> <br>
    CLICK HERE <br>
    <br>
    </p>
    </body>
    </html>


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