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
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HTML
TEXT OF PAGE FROM 1999:
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<title>VAXGEN ~ Vaccine Trials
against HIV for HIV-Negative
men</title>
<base
href="http://www.barebackjack.com/vaxgen.html">
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background="redribbon.jpg">
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<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>
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