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.
TO
GO BACK TO JACK'S MENU
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;
font-family:arial} H5{color:#00004f;
font-size:10pt;
font-family:copperplate gothic bold}
H6{color:#50004C;
font-size:30pt; font-family:copperplate gothic
bold}
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 "vaccinations"
(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>
|