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 Study: HIV Vaccine Volunteers Need More
Support From Researchers
by The Canadian Press
Posted: March 20, 2008 - 3:00 pm ET
(Toronto, Ontario) When it comes to developing a safe, effective vaccine to stem the
global AIDS pandemic, researchers agree there is one component they can't do
without - volunteers willing to become human guinea pigs for testing the
experimental serums.
Tens of thousands of participants will be needed for clinical trials of
vaccines aimed at preventing HIV
infection, yet one study has found lots of reasons why people might be wary of
offering up their bodies to advance this particular cause of science.
That's likely even more the case since the field suffered a major setback
last fall, when a promising vaccine developed by pharmaceutical giant Merck not
only failed to work in what was known as the international STEP trial, but
actually increased the risk of infection in some volunteers.
A group led by Peter Newman, a professor of social work at the University of
Toronto, decided to interview a number of people who had volunteered for the
Toronto portion of STEP, but decided not to take part after going through the
initial enrolment process.
Their reasons, he said, should be a cautionary tale for researchers in any
future vaccine-testing endeavors.
``Pretty much, they all had altruistic intentions, that's why they did this
in the first place,'' Newman said of would-be volunteers in Toronto, most of
them gay men. ``They said they wanted to help find a cure or
find something that would prevent this disease ... they had a friend who was ill
or had died in the past and they wanted to do their part.''
``That was really across the board. So it's the issue that even despite that
and the fact that they came in and said, `Hey I'll do whatever tests I need to
do to see if I'm eligible,' they said, `When push comes to shove, I really don't
want to do this.'''
In questionnaires and interviews, 13 decliners in Newman's study cited a
number of reasons for pulling out, chief among them concerns about coming up
positive on an HIV test (even if they weren't actually infected) due to
antibodies produced in response to the vaccine.
Respondents saw all kinds of possible repercussions from such a
false-positive result, he said. As one explained:
``This could change your life. We are not talking about getting little round
spots on your hands or something. We are talking about showing up positive. How
can you tell your doctor, your insurance company? Like, how do you deal with
that? Because this has a huge stigma for people.''
A couple of subjects who decided against enrolling in the trial had contacted
private medical insurance providers and were told they would not be eligible for
some coverage if they took part, he said.
Some worried that a false positive might hurt their ability to get life
insurance; others feared being denied entry to the United States (non-citizens
with HIV are inadmissible by law) to work or visit friends and family.
Still others were concerned about their relationships, Newman noted. ``They
said, `How am I going to explain to my partner? How am I going to explain to
some guy I might meet and really like, you know I'm positive but I'm not
really?'''
His study, recently published in the journal Vaccine, found that fears about
possible side-effects from taking an investigational vaccine, inadequate
remuneration and committing several years to a particular trial also tipped the
balance against participating.
Jose Sousa, chair of the community advisory committee for the Canadian HIV
Trials Network, called the concerns raised by the Toronto respondents ``pretty
right on,'' and said they are surprisingly representative of the broader
community of people at elevated risk for HIV and thus candidates for vaccine
trials.
``The big thing is being antibody-positive afterwards and insurance,'' Sousa
said from Montreal. ``You don't know it's a false positive until it's
double-checked and insurance (companies) don't do that.''
Newman suggests future trials should be set up to provide more support for
those people willing to roll up their sleeves for experimental inoculations,
including free psychosocial counseling; an ombudsman to deal with insurers and
other institutions; and reasonable payment for time, effort and risks involved
with the research.
They are suggestions that scientists should not ignore, advised Sousa. ``If
they want their studies completed, they better listen to the community.''
Addressing such concerns will be critical for future vaccine research, agreed
Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise in
New York, especially since the STEP trial results may have made potential
volunteers gun-shy about coming forward.
``So if volunteers think the next trial is either not going to work or fail,
then they're going to be increasingly resistant to volunteer for trials because
they'll figure the scientists have lost their way and don't really know which
way to go.''
Yet Bernstein doesn't view the STEP trial as a failure _ as many have called
it _ but a learning experience that will help researchers refine the next
generation of test vaccines.
``I think the failure has been our expectation that one vaccine trial would
be a home run, would give us a vaccine ... So I think we have to convey to the
communities who are potential volunteers that this is a long, incremental
journey and a learning journey _ and we need their help.''
Dr. Rafick-Pierre Sekaly, a vaccine researcher at the University of Montreal,
agreed that the STEP trial may mean some people will be leery of getting
involved in subsequent research.
Yet, even with pre-testing in laboratory animals, scientists cannot foretell
how a person's immune system will react to an inoculation, Sekaly said. ``The
primate model is not a predictor, the mouse model is absolutely by no means a
predictor.''
``The only way to know if a vaccine is going to work or not is by going into
humans.''
©365Gay.com 2008
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