First Human Trial of 'Global' HIV Vaccine Launched
Thu November 14, 2002 06:10 PM ET
By Alan Mozes
NEW YORK (Reuters Health) - American researchers have reached
what they hope is a milestone in AIDS research, with the launch of
the first human trial of a single AIDS vaccine designed to
simultaneously prevent infection with the three most common forms of
HIV.
The first trial phase of the so-called "global vaccine" was
launched yesterday by the National Institutes of Health (NIH) in
Bethesda, Maryland, under the supervision of the Vaccine Research
Center (VRC).
The trial vaccine incorporates modified parts of four different
HIV genes. The genes are drawn from HIV subtype B--the most
prevalent form of HIV in North America and Western Europe--as well
as from subtypes A and C, which are the most common types in Africa
and Asia.
Together the three types--or clades--of HIV account for about 90%
of infections worldwide.
"The idea behind having this global vaccine candidate is to
broaden the coverage of the vaccine," said Dr. Gary Nabel, director
of the VRC. "It's giving a broader shield. And it has special
relevance in the developing world, but it's also something that
doesn't hurt here in North America--where we have clade B--because
we don't lose anything."
Nabel pointed out that early lab tests with animals have already
shown that immune response to any single type of HIV was not
diminished by combining such protection against all three major HIV
types. And he noted that the history of vaccine development supports
the notion that such a combo vaccine can work.
"If you look at the polio vaccine, it actually contains three
different strains of the disease to cover the three different most
prominent strains, so there's an important precedent for that
concept," he told Reuters Health.
"When we talk about developing a vaccine for AIDS, I think the
one lesson we've learned with time is that this is a virus that
doesn't sit still," Nabel noted. "The virus is constantly mutating,
and seems to be adapting to different populations. So the idea
behind having this global vaccine is that we are trying to...have a
better chance of resisting the newer viruses that develop."
The trial's first phase will involve 50 healthy, HIV-negative
volunteers between the ages of 18 and 40 who will receive multiple
inoculations with either the test vaccine or a saline solution
placebo over the course of one year.
Nabel and his colleagues expressed confidence that whether or not
the vaccine proves effective over time, the vaccine itself is
completely safe for use in a public trial.
"You would not get the infection from this vaccine, that's very
clear," said Nabel. "It couldn't happen. We've completely modified
the genes with multiple mutations to protect from any kind of
activity. So that's something I can be quite definitive about.
"But," he added, "everyone who comes into this trial gets
counseling about avoiding risk, because there's no proof yet that
this vaccine will protect them. So they are still susceptible to
natural infection."
Even if all goes well throughout the clinical trial process,
Nabel noted, the vaccine will not become available to the public
until at least five years from now.
Sven Bocklandt--the first volunteer to receive an
injection--emphasized his hopes for the vaccine's prospects, rather
than any risks it might pose.
"AIDS is a disease which personally affects me," Bocklandt--a
28-year-old NIH research fellow unconnected to the VRC project--told
Reuters Health. "It's threatening my life and all the people I care
about pretty much... And the only way you can eradicate it is
through a vaccine. That is the only solution to the AIDS crisis. But
you cannot develop a vaccine unless you test it in people and see
how they respond to it. That's the bottom-line for me. So that's why
I'm doing this." |