News (Updated
September 12, 2010)
[Home]
[Previous
news]
Vaccines
Keith Alcorn
Published: 08 September
2010
Global HIV Vaccine
Enterprise director, Dr Alan Bernstein
Jump to
Global HIV Vaccine
Enterprise sets out road map for next five years
Further information
Global HIV Vaccine
Enterprise sets out road map for next five years
Following last year’s
positive result from an HIV vaccine trial in
Global HIV Vaccine
Enterprise executive director Dr Alan Bernstein also called for young scientists
to get involved in the field of HIV vaccine research.
The plan, available for
download at the Global HIV Vaccine Enterprise website, outlines two key
priorities: better integration of the latest information from basic science and
ongoing trials into new vaccine studies, and better use of information from
preclinical studies and from other areas of scientific research.
Aidsmap.com spoke to Dr
Alan Bernstein, pictured above, about some of the priorities in the HIV vaccine
field.
Following the failure of
the adenovirus-based HIV vaccine developed by Merck in 2008, there has been
considerable debate about the future of HIV vaccine research, with some
pronouncing the field a dead-end, and others calling for a back-to-basics
approach to investigating how HIV interacts with the immune system.
But the Global HIV
Vaccine Enterprise says that as well as more laboratory science, more trials in
humans are needed if we are to answer the fundamental questions still puzzling
vaccine researchers.
One example of the sort
of question that needs to be answered is: which immune system changes after
vaccination correlate with protection against HIV, and do these changes indicate
a mechanism by which the immune system protects against HIV infection that can
be exploited in future vaccine development?
The Thai trial of a
two-vaccine regimen that reduced the risk of HIV infection by 31% is still being
analysed to determine what can be learnt about the correlates of protection,
with laboratories all over the world currently examining samples provided by the
trial sponsors.
Dr Bernstein is hopeful
that the pipeline of promising candidate vaccines will soon offer some serious
follow-up candidates to the vaccines tested in the Thai trial and the STEP and
Phambili trials, but larger trials of promising candidates need to get underway
more quickly.
“We need to go from one
phase 2b study every seven years to something like one every year, so that we
have the opportunity to incorporate new findings into the design of studies.”
The Global HIV Vaccine
Enterprise calls this process “integrating iterative scientific enquiry with
product development.”
This means quickly
incorporating new information from ongoing studies or failed studies into the
design of new studies and trials that are just getting underway. It also means
sharing data more quickly and testing a wider variety of vaccine approaches
sooner in human efficacy trials.
“Trials are expensive
– phase III trials cost at least $120 million over their lifetime. [Starting
one each year] implies a ten to fifty-fold increase in funding. So if there’s
another breakthrough like the Thai trial we may need more than a 50% increase in
funding.”
However Dr Bernstein
declined to say how much the Global HIV Vaccine Enterprise needs in order to
fully realise its plans.
The need for lots of new
efficacy trials also implies the need for a big investment in clinical trials
infrastructure. Vaccine trials may need to recruit tens of thousands of people
to prove efficacy in the future, especially if expanding treatment has a greater
effect on transmission at the same time as other prevention interventions are
also reducing HIV incidence.
“Partnerships are
needed between the developed and developing world. The cost of building that
trials capacity is a drop in the ocean in comparison with paying for the
drugs.”
“I don’t like
dichotomous discussions, treatment or prevention, short-term or long-term. If
we’ve learnt anything about this epidemic, it’s that it needs a long-term
multifaceted approach. If we don’t implement what we know works, we’re not
going to control this disease.”
“Making efficient use
of clinical trial sites, regardless of prevention modality and funder, is going
to be critical. Before we ask for more resources we need to be very sure that we
are using existing resources to maximum efficiency.”
The Global HIV Vaccine
Enterprise is also seeking to mobilise new financial resources, and new research
capacity.
“There are some
countries that are doing very little in terms of HIV vaccine research,” said
Dr Bernstein, although he wouldn’t be drawn into naming names. (
“I’m very pleased
that
Responding to perceptions
outside the HIV field that a vaccine for the infection is impossible, Dr
Bernstein said: “It’s as likely that there will be a vaccine for HIV as
drugs for Alzheimer’s or some types of cancers. There are sound reasons to
believe that we can get a vaccine.”
But the development of
successful vaccines is likely to depend on the renewal of the research workforce
too. Dr Bernstein says that the HIV vaccine field needs young scientists who
have the ambition to make a career in this area.
“Pasteur said that what
every scientist wants is to make a great discovery, to have it applauded by your
peers and to benefit humanity. I can’t think of a better field than HIV
vaccine research [to fulfil these needs]. It’s become apparent that because of
the difficulty in developing a vaccine, we’re going to need great scientists.
For young scientists it’s a great opportunity.”
The vast majority of
Nobel Prize winners in the natural sciences did the work that led to their prize
before the age of 40, Dr Bernstein points out.
“Young people have
energy, the naivete to be a great scientist, the openness to new ideas. Watson
was 23 when he was doing the most important work in biology, the discovery of
the DNA double-helix, and he and Crick wanted to beat the old guy, Linus Pauling.”
The HIV Vaccine
Enterprise also wants to catalyse interest in solving some of the problems
inherent in making an HIV vaccine by reaching out to other fields, such as
systems biology and genomics.
“We rely on the immune
system to do our work [when making a vaccine]. When it works that’s
fantastic but when it doesn’t work, there’s an imperative to find out
what’s going on. There’s a very complex set of interactions and we need a
deep biological understanding of that complexity.”
There is a need to use
computation and new developments in networks theory to understand the
relationships between millions of fragments of information derived from studying
vaccine responses, and the interactions between HIV and the immune system.
New technologies also
need to be exploited in the search for a vaccine.
“There’s good reason
to think mucosal immunity is critical in HIV transmission, but how do we monitor
what’s going on in the mucosa without invasive and impractical tissue
sampling? Is there a non-invasive way to imaging at the mucosal surface to tell
us what’s going on during the very earliest stages of infection? There’s
been a revolution in imaging technology and we should talking to the [imaging
experts].”
Thu, Sep 9 2010
CHICAGO (Reuters) -
Johnson & Johnson has pledged grant money, drugs and research funding for
new HIV and tuberculosis medications as part of a five-year, private sector
effort to improve the health up to 120 million women and children in developing
nations each year.
The announcement on
Wednesday by the drug, medical device and consumer products company supports the
United Nations' call this year for a renewed push to meet the Millennium
Development Goals of preventing premature deaths in women and children by 2015.
"We have a
responsibility to contribute to a future in which women and children have the
latest knowledge, technology and medicines to support good health," J&J
Chief Executive William Weldon said in a statement.
New Jersey-based J&J
did not say how much it was spending on the effort.
The announcement came
just weeks before a U.N. summit from September 20 to 22 in
J&J will take
advantage of the vast reach of mobile phone technology, with more than 1 billion
women in low- and moderate-income countries owning a cell phone.
The company will launch a
program called Mobile Health for Mothers, sending free mobile text messages on
prenatal health, appointment reminders and phone calls from health coaches to
women in
Other moves include:
* A fourfold spending
increase on efforts to fight intestinal worms in children, with the hope of
donating 200 million doses a year of its intestinal worm treatment mebendazole.
* J&J hopes to
distribute the drug in 30 to 40 countries by 2015, and the push includes
educational efforts to keep children from getting reinfected.
* J&J plans to
continue its efforts to develop new drugs for both human immunodeficiency virus
or HIV, the virus that causes AIDS, and for TB, conditions that hit poor women
and children in developing countries especially hard.
* The company plans to
expand its education efforts to prevent mothers from passing along HIV to their
children and other issues that affect maternal health.
"This is the type of
initiative we have called for, and I commend the emphasis on integration of
mobile technologies, medicines, new science and prevention," U.N.
Secretary-General Ban Ki-moon said in a statement.
Sep 8 2010
By Pete Harrison
BRUSSELS (Reuters) -
Primates, including mankind's closest relatives -- chimpanzees, gorillas,
bonobos and orangutans -- have gained new protection after the European
Parliament backed a clampdown on animal testing.
"The use of
non-human primates should be permitted only in those biomedical areas essential
for the benefit of human beings, for which no other alternative replacement
methods are yet available," a new EU law said.
The strongest protection
was given to the "great apes," although sustained public pressure has
already ensured none have been used in European Union research in eight years.
Less stringent measures
were brought in to protect the 12,000 other smaller primates, such as macaques,
used in EU labs each year.
The revision of the
25-year-old rules had originally envisaged a more complete ban on primate
research, but were heavily contested and lobbied by industry.
Researchers argued
primates were indispensable for work to find cures for diseases including HIV,
Alzheimer's Disease, cancer, hepatitis, malaria, multiple sclerosis and
tuberculosis.
In theory, great apes can
be used in such research, but in practice license applications face rigorous EU
scrutiny.
Researchers said a fair
balance had been found.
"Today's agreement
should bring direct and tangible animal welfare benefits and allow essential
medical research to continue in
Some 12 million
vertebrate animals are used each year in experiments throughout the 27-nation EU
-- half for drug development and testing, a third for biology studies and the
rest for cosmetics tests, toxicology and disease diagnosis.
Around 80 percent are
mice and rats and primates account for around a tenth of 1 percent or about
12,000 animals.
Researchers will have to
keep files on the history of each individual primate, dog or cat to ensure their
welfare needs are met. They will also be obliged to use alternatives to animal
testing whenever they are available.
Government authorities
will be required to perform inspections on laboratories, some of them snap
checks.
Animal rights campaigners
gave the rules a mixed welcome, saying they represented business as usual for
laboratories in
"This directive also
sends a challenge to other countries such as the
(Reporting by Pete
Harrison)
Gilead Sciences has
submitted an application for European marketing approval of a new combination
therapy for adult HIV sufferers.
The marketing authorisation application submitted to the European Medicines
Agency pertains to a fixed-dose combination of
Should the application meet with success, it would become the second product on
the market to offer a complete antiretroviral treatment regimen in a single
once-daily tablet.
Dr John Martin, chairman and chief executive officer of Gilead Sciences, said:
"We are pleased to work with Tibotec in contributing another potentially
important new once-daily, fixed-dose treatment option."
In July 2010 
Abbott Laboratories (ABT)
has recalled some HIV blood screening tests following customer complaints of
"calibration failures," the U.S. Food and Drug Administration said
Thursday.
Abbott recalled one lot
of the Prism HIV O Plus, carrying lot number 87334M500, the FDA said. The FDA
said customers who have an alternate supply of the product should stop using the
recalled lot and discard it. Customers who don't have an alternate lot are asked
to continue using the recalled lot until replacement kits arrive.
Abbott spokesman Don
Braakman said "certain calibration controls were found to be out of
specification."
There have been no
reports of any effect to test results affecting blood donations or the supply of
blood products, he said. Abbott alerted its customers and the FDA of the issue
last week and has already replaced the lot, Braakman said.
The FDA approved the
product nearly a year ago. The screening tool, which is used by laboratory
professionals, is designed to detect the presence of antibodies to the two types
of virus that causes AIDS, HIV-1 and HIV-2, and help in the diagnosis of HIV
infection. Abbott called it the first fully automated blood screening test for
HIV-1/HIV-2. The Prism system can run about 160 samples per hour. The Prism
system also can handle screens for hepatitis and other infections.