######## Statement of the International AIDS Vaccine Initiative 

######## to the President's Advisory Council on HIV/AIDS

########  December 15, 2003

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# IAVI's mission is to ensure the development of safe, effective, accessible, preventive AIDS vaccines for use throughout the world

With new HIV infections continuing to occur at a rate of 5 million per
year---and AIDS claiming 3 million lives annually, despite expanding
access to antiretroviral therapies---a preventive vaccine is needed more
urgently than ever. A vaccine that shields people from HIV infection
*before* the disease can strike is our best hope to contain this
terrible epidemic. An AIDS vaccine is within reach, but only if the
world mobilizes a concerted effort to push promising candidates from the
laboratory into clinical trials, and takes the necessary steps to ensure
access as broadly and rapidly as possible. It is critical to remember
that even in sub-Saharan Africa, the most affected region, the vast
majority of people -- more than 90% -- have not acquired HIV. Enabling
them to remain HIV-free is a massive challenge, with the protection of
young people an urgent priority.

The International AIDS Vaccine Initiative (IAVI) is a global
public-private partnership working to speed the development and
distribution of safe, effective, and accessible preventive AIDS
vaccines, with a particular focus on the developing world. Our unique
approach is to pursue our scientific programs in full partnership with
the developing countries most affected by the epidemic, and in parallel
with a policy advocacy program to encourage advance preparation for how
a future vaccine can and will be made accessible to all without delay.

Founded in 1996, IAVI's work focuses on accelerating scientific
progress; mobilizing support through advocacy and education; assuring
global access; and encouraging industrial participation in AIDS vaccine
development. We believe that a vaccine, complemented by education and
treatment, can end the epidemic. IAVI partners with researchers,
community groups, political and religious leaders and others around the
world toward this common goal. IAVI fills many roles: vaccine advocate,
product developer and clinical trial sponsor.

Developing an AIDS vaccine is scientifically possible but will require
tremendous international cooperation. IAVI is working on seven different
vaccine approaches with partners in Africa, Asia, North America, and
Europe, in academia, government agencies, and private industry. We have
also established the Neutralizing Antibody Consortium---a novel working
group of scientists and their academic institutions collaborating to
solve the most critical scientific challenge in AIDS vaccine
development. We are currently conducting clinical trials in Kenya,
Uganda, South Africa, the UK, Belgium, and the US, and plan to begin
trials shortly in Germany, Rwanda, and India. We are excited about how
much progress we have made in so short a time, but major obstacles
remain: scientific challenges, the limited number of promising vaccine
candidates ready to move from laboratory to clinical trials, and the
need for far greater resources to accelerate global research and
development. Vaccine research commands only 2% of the approximately \$20
billion the world spends annually on AIDS prevention, research and
treatment.

**Partnership**

IAVI's unique approach to AIDS vaccine development is to pursue our
scientific programs in full partnership with the developing countries
most affected by the epidemic, and in parallel with a policy advocacy
program to encourage advance preparation for how a future vaccine can
and will be made accessible to all without delay. We work closely with a
variety of partner organizations around the world to broaden global
support for finding an AIDS vaccine. A broad range of non-government
organizations actively collaborate with IAVI to increase awareness of
the need for an AIDS vaccine and to secure additional financial
resources to support this global effort. We work with researchers,
governments, donors, and affected communities on this important joint
effort.

IAVI and its partners in the developing world are increasingly working
to link vaccine research and development to primary prevention and
treatment programs. Clinical trials should be accompanied by
high-quality voluntary counseling and testing (VCT) and treatment for
those already infected and in need. Those who are HIV negative should
have access to primary prevention and potential clinical trial
participation. Thus the long-term objective of developing an HIV
preventive vaccine can yield more immediate public health benefits.

 **IAVI's R&D Agenda**

** **

IAVI is currently supporting the development for clinical testing of 7
promising vaccine candidates, all of which are based on subtypes of HIV
most prevalent in developing countries, primarily subtype A (East
Africa) and subtype C (South Africa, India and China).

 

IAVI provides funding, technical support and project management to a
series of partnerships between researchers in developed and researchers
and institutions in the developing countries, currently Kenya, Uganda,
India, South Africa, Brazil, Rwanda and China. U.S. and European
researchers and institutions also play a major role in IAVI's
partnerships and activities.

 

IAVI's vaccine partnerships aim to accelerate the clinical testing of
promising vaccine candidates, with the aim of building country capacity
and support for the conduct of large scale efficacy trials in developing
countries as soon as possible. In all cases IAVI provides ongoing
training and support for individual trials to meet the highest standards
of clinical and ethical practice while also coordinating information
exchange and ensuring dissemination of best practices between sites.

 

Importantly, IAVI support is conditional on all partners agreeing that
if a vaccine candidate is successful, it will be made available at an
affordable price for use by developing countries.

 

IAVI also provides a Core Laboratory facility, based in London, to serve
as a reference to standardise and compare results from IAVI supported
and other trials. The ability to effectively compare results from
different trials is essential to improving strategic decision-making
regarding the progress of different candidate vaccines.

 

**Clinical Trials in Kenya, Uganda, South Africa, and Rwanda**

** **

IAVI has established unique research partnerships in Kenya, with the
Kenyan AIDS Vaccine Initiative (KAVI) based in Nairobi, and Uganda, with
the Uganda Virus Research Institute (UVRI) based in Entebbe. With
support from IAVI, Kenyan and Ugandan research teams have been
successfully conducting small scale Phase I clinical trials of a DNA-MVA
vaccine strategy based on a Kenya subtype A virus. These have been the
first trials in the world to test HIV vaccine candidates specifically
developed from African HIV isolates. IAVI's core laboratory in London
has provided ongoing training in good laboratory practice and acts as a
reference laboratory to validate results from both country sites. In
addition, IAVI has also recently begun to work with Projet San Francisco
in Rwanda (PSF) to develop a collaborative agenda and action plan to
undertake feasibility work leading up to the development of protocols
for Phase I and Phase IIb clinical trials in Rwanda.

In South Africa, IAVI collaborates closely with the South African AIDS
Vaccine Initiative (SAAVI) and the Perinatal HIV Research Unit at Chris
Hani Baragwanath Hospital in Soweto. A Phase I trial was initiated in
November 2003.

 

IAVI and its country partners are now planning and preparing for
large-scale, multi-country HIV vaccine efficacy trials in East and
Southern Africa to begin 2004--5. This will be the first HIV vaccine
efficacy trial to take place in Africa.

 

Such an efficacy trial requires major clinical, research, community and
human resource infrastructure in participating countries. IAVI has
worked to support such capacity development with and by developing
country partners.

 

Co-ordination and project management of multiple trial sites,
standardisation of operating procedures, quality control and assessment
are essential if a trial is to meet international research standards and
produce valid results.

 

IAVI's established partnerships in Kenya, Uganda, and South Africa, new
partnerships in Rwanda, and the crucial role of the core reference lab
place it in a unique position to play this co-ordinating role.

* *

**Community preparedness, participation and partnerships**

In order to attain the project's objectives, IAVI works with regional,
national and local partners, including scientists, policy makers,
communities, the media, NGOs & CBOs, and other stakeholders to be active
partners and participants in all aspects of the process: conducting
research; promoting policies that streamline regulatory bottlenecks;
building sufficient community health infrastructure; advocating for
global funding. In Uganda, IAVI has worked with a broad coalition of
stakeholders and partners in the development a National Vaccine Plan
that provides the foundation for IAVI, UVRI and many others to work
towards a common agenda with the full support of the government through
the Ugandan AIDS Commission. This project seeks to adapt this process
throughout the region.

 

In addition to working with specific communities and partners at the
country level in Kenya, Rwanda, South Africa and Uganda, IAVI has also
developed a regional network to link these partners together to share
experiences, resources and lessons learned.

 

By engaging communities and building local capacity in all aspects of
vaccine development, IAVI seeks to serve both the short-term goal of
most efficiently conducting trials while ensuring sufficient
preparation, trust and ownership to meet the ultimate goal of rapid
adoption of a resulting vaccine.

 

**HIV Vaccine Access**

 

All IAVI supported research partnerships include undertakings from
participants to make any future successful product available at low
price and in sufficient quantities for use in developing countries.

 

Intellectual property rights pertaining to the clinically most developed
of IAVI supported vaccine candidates, the DNA-MVA vaccines currently
being tested in UK, Kenya, Uganda and South Africa, are shared by the
University of Nairobi, the Medical Research Council (UK) and IAVI.

 

IAVI's public policy department focuses on the development of policy and
advocacy to ensure rapid and widespread use of future HIV vaccines by
developing countries. IAVI has worked closely with donor governments,
developing country partners, the World Bank and WHO-UNAIDS in developing
this 'access agenda' as an essential complement to R&D efforts.

**Call to Action**

We hope that the United States will make finding an AIDS vaccine a top
priority and commit to significantly increasing funding for AIDS vaccine
research along with significant overall increases in AIDS research. The
US Government has provided an array of incentives to marshal expertise
in biotech and pharmaceutical companies to meet the threat of
bioterror.  Similar incentives are needed to encourage industry
involvement in AIDS vaccine research. The United States should also
commit to ensuring an AIDS vaccine is available globally by creating
legally binding pre-commitments or contracts to buy AIDS vaccines for
international use.

Together, we can realize our shared vision, the greatest hope of our
time---a world without AIDS.