Safety of Trial Volunteers Must Remain Paramount Concern
Wednesday, November 7, 2007
Contact: Mitchell Warren, +1-914-661-1536, mitchell@avac.org
Seattle, Washington, November 7,
2007, The AIDS Vaccine Advocacy Coalition
(AVAC) released the following statement today
from Executive Director Mitchell Warren in
response to the release of new data from the
STEP AIDS vaccine study by Merck & Co., the
US National Institute for Allergy and
Infectious Diseases (NIAID) and the HIV Vaccine
Trials Network (HVTN) at a public forum at the
HVTN meeting today.
The data from the
STEP study released today confirm that the
vaccine was not effective at either preventing
infection in male volunteers or at reducing
viral loads in male vaccine recipients who
became infected with HIV during the trial. In
addition, the data suggest that the vaccine may
have made some volunteers more susceptible to
acquiring HIV infection. The vaccine itself
does not cause HIV. This trend was specifically
observed among male volunteers who had high
titers of antibody to adenovirus, the cold
virus that was used, in a disabled form, in the
MRK-Ad5 vaccine candidate.
"These data
are deeply disappointing and troubling, and
raise more questions than answers for the field
of AIDS vaccine. Today's discussion of the data
underscores the leadership and transparency
that Merck, NIAID, and HVTN continue to show in
this complex and challenging time. What is
clear is that the field must continue to work
on this challenge and on the larger goal of
finding a safe and effective AIDS
vaccine.
"As much as we would like to
see a clear answer in these results to whether
or not the vaccine made some volunteers more
susceptible to HIV infection, the reality is
that there is still significant confusion about
the underlying explanation for the observed
effect.
"As we move forward, the work of
analyzing and interpreting the data from the
STEP study, and from the companion Phambili
study in South Africa, will become even more
difficult and even more important.
"In
the weeks and months to come, we look to the
AIDS vaccine field as a whole to maintain a
collaborative spirit and to commit all
necessary resources to the critical work of
understanding the potential explanations and
implications for the trends observed in the
STEP study.
"We commend the trial
sponsors for their consistent commitment to the
safety of the volunteers, which must be the top
priority in this and every other HIV prevention
trial. At every stage of this difficult
process, trial sponsors and site-level staff
must continue to clearly communicate key
information about the data and the
participants' potential risk to volunteers at
every site.
"AVAC recognizes that these
data leave the AIDS vaccine field with a range
of difficult decisions. Going forward, we
believe that the wisest course of action is
also the most cautious. To safeguard future
trials and volunteers, the trial sponsors
and the field as a whole should take as long as
is needed to analyze the data and attempt to
come to more definitive conclusions about what
these new data mean, before beginning efficacy
trials of other vaccine candidates.
"In
addition, if there is the possibility that
unblinding the STEP study and informing every
participant about whether he or she received
the placebo or the vaccine will provide an
additional safeguard for participants, then
this is the course of action that should be
taken. AVAC believes that ultimately the
decision about unblinding the trial should be
guided by the participants' own concerns and
priorities.
"Above all, we must continue
to see this for what it is: a major setback for
the AIDS vaccine field, but one that can and
must be overcome through rigorous scientific
investigation, open communication with
communities, and a firm commitment to the
shared goal of reversing the course of the AIDS
epidemic in our lifetimes."
AVAC will
continue to provide updates, analysis and
resource materials at http://avac.org/pr_step_study.htm
as the decision about unbinding the trial is
made and as more analyses and data are
released.
About AVAC
Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other HIV prevention options. To help assure its independence, AVAC does not accept funding from government or pharmaceutical industry sources. For more information, visit www.avac.org.