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DUDE
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      #6412 - 06/29/00 10:07 PM

NIAID Puts More Weight Behind AIDS Vaccine
Development

The National Institute of Allergy and Infectious Diseases (NIAID) announced
on Tuesday four novel public-private partnerships to accelerate
development of promising HIV/AIDS vaccines for use around the world.

The new partnerships, called HIV Vaccine Design and Development Teams
(HVDDT), tap the different skills and talents of private industry and
academic research centers, and provide incentive to move strong HIV/AIDS
vaccine candidates out of the laboratory and into human testing.

NIAID has committed to spend approximately $70 million over the next five
years on the four HVDDT contracts that have been awarded.

The HVDDT program responds directly to President Clinton's call to
increase public-private cooperation in developing vaccines against globally
important diseases such as AIDS, tuberculosis and malaria.

"Many vaccines in use today resulted from both government-sponsored and
private research," explains Anthony S. Fauci, M.D., director of NIAID. "The
HVDDT program is a unique addition to this model that encourages the
private sector to increase their AIDS vaccine efforts while allowing NIAID to
work closely with its partners throughout the development process."

Designing and testing vaccines for diseases like AIDS is an expensive and
scientifically complex undertaking with no guarantees of success and little
likelihood of significant profit.

"The HVDDT program encourages pharmaceutical companies to invest
more in AIDS vaccine research by partially offsetting their financial risk. In
essence, HVDDT contracts 'prime the pump' to get the vaccine-production
engine running, including vaccine candidates for HIV subtypes that circulate
in developing countries," explains Peggy Johnston, Ph.D., assistant director
for AIDS vaccines at NIAID.

HVDDT awards are incentive-based contracts aimed at vaccine
candidates in the middle of the development pipeline -- those not yet in
clinical testing.

Applicants were required to describe a clear development plan, including
timelines to indicate when different phases would be completed. Funding
will be provided in increments as these preset milestones are reached.

"This goal-based incentive structure helps ensure continuous progress
toward a testable vaccine while at the same time rewarding companies for
research accomplishments made along the way," states Dr. Johnston.

Each of the initial HVDDT contracts proposes using a DNA-based HIV
vaccine for the initial immunization. The proposals differ in the unique
properties of the DNA, the specific immune response that is targeted, the
delivery system used, and the manner of boosting the initial vaccine.

Each of the proposed vaccines contains the genetic information to make
specific HIV proteins, either from the outer viral envelope or the internal viral
core, to induce an immune response.

The vaccines do not contain enough genetic information to construct a
complete virus, and therefore will pose no threat of HIV infection to study
participants.

The four research organizations that have received an award and a
summary of their proposed projects are listed below.

Advanced BioScience Laboratories, Inc. (ABL), Kensington, MD

Under the direction of Phillip Markham, Ph.D., researchers from ABL and
the University of Massachusetts Medical School will develop and test a
DNA vaccine containing genes for envelope proteins from HIV strains
isolated around the world.

Study participants will receive non-DNA booster vaccines consisting of
engineered, or recombinant, HIV proteins. The researchers will explore
ways to enhance the antibody response to this vaccine and hope that this
combination will provide broad immunity against the different subtypes of
the virus found worldwide. ABL is an affiliate of Organon Teknika
Corporation in Durham, NC.

Chiron Corporation, Emeryville, CA

Susan Barnett, Ph.D., and colleagues at Chiron will produce a DNA vaccine
candidate based on a common U.S. HIV subtype called clade B. They will
also work on a vaccine based on a clade C virus, the most common HIV
subtype in sub-Saharan Africa and India.

The vaccines, consisting of HIV envelope and core protein genes, are
designed to stimulate antibodies and T cells that attack the virus and
virus-infected cells, respectively.

The DNA vaccine will be followed by a booster vaccine consisting of
alphavirus particles, which serve as novel delivery vehicles to ferry a
recombinant HIV protein to certain immune cells.

By slightly changing the genetic code of the vaccine's DNA, Chiron
scientists hope to improve the ability of the body to decode the genetic
instructions once the vaccine is administered. The investigators will also
study different ways to enhance the immune response to the DNA vaccine.

University of New South Wales, Australia

David Cooper, M.D., will lead a consortium of Australian universities and
research organizations in producing a DNA vaccine that contains HIV
genes as well as specific stretches of DNA that directly stimulate immune
responses.

The vaccination boost will contain HIV genes contained in a viral (fowlpox)
delivery system that also contains immunity-enhancing genes. This vaccine
is designed to stimulate both antibody and T-cell responses and to
generate active immunity at mucosal surfaces, the first site of viral assault
during most HIV infections.

Wyeth Lederle Vaccines and Nutrition, Pearl River, NY

Wyeth Lederle's John Eldridge, Ph.D., will direct an effort with academic
researchers at the University of Pennsylvania and Duke University to
produce a DNA vaccine containing immunity-stimulating genes in addition
to the HIV genes.

The initial DNA vaccination will be boosted by a candidate vaccine
consisting of multiple protein fragments, or peptides, that trigger anti-HIV
responses. The goal of this approach is to produce a vaccine that strongly
stimulates HIV-specific immune responses in very diverse human
populations.

The HVDDT awards are part of NIAID's expanded commitment to develop
an HIV vaccine, and the contracts complement other currently supported
HIV vaccine research and development programs.

The Innovation Grant Program (IGP) supports novel, high-risk, and
exploratory studies in AIDS vaccine-related research.

The HIV Vaccine Research and Design Program (HIVRAD) supports
studies emphasizing targeted AIDS vaccine research and development and
is designed for vaccine concepts that have already generated significant
preliminary data.

The Integrated Preclinical/Clinical AIDS Vaccine Development Program
(IPCAVD) supports grants designed to move promising HIV vaccine
candidates into preliminary human studies. IPCAVD awards are not
milestone-driven, however, because they support vaccine development at
an earlier stage than the HVDDT contracts, where timelines are more
difficult to predict.

NIAID also supports HIV vaccine development through its Vaccine
Development Resources program, which assists AIDS researchers by
manufacturing pilot lots of vaccine for testing, conducting preliminary safety
and efficacy evaluations, and preparing submissions to the Food and Drug
Administration for trials in humans.

More recently, NIAID announced the funding of the HIV Vaccine Trials
Network (HVTN), a global network of clinical sites, which will conduct all
phases of clinical trials of candidate HIV vaccines.

NIAID is a component of the National Institutes of Health (NIH). NIAID
conducts and supports research to prevent, diagnose and treat illness such
as HIV disease and other sexually transmitted diseases, tuberculosis,
malaria, asthma and allergies. NIH is an agency of the U.S. Department of
Health and Human Services. - By Sam Perdue

Related websites:

NIAID Vaccine Development

NIAID

[Contact: Sam Perdue]

28-Jun-2000




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