6 Years and Counting: Can a Shifting Landscape Accelerate an AIDS Vaccine?

MAJOR NEW PLAYERS
STATUS IAVI Continues Growth, VRC And HVTN Organizing * Agendas And Collaboration Still Too Limited * Academic Centers Emerging. Gates
Foundation Shows Leadership RECOMMENDATIONS IAVI, VRC And HVTN Should Coordinate And Share * Include Adolescents In Trials * VRC
And HVTN Should Develop Agenda And Milestones * Gates Should Build On Leadership

As further evidence of the shifting landscape in
HIV vaccine development, the last few years
have seen the creation of several new organizations expressly for such purpose. New government
initiatives, more varied sources of public support,
and new major funding from the Bill & Melinda
Gates Foundation have led to the establishment of
the International AIDS Vaccine Initiative (IAVI) in
1996, NIH's Vaccine Research Center (VRC) in
1997, and the HIV Vaccine Trials Network (HVTN)
in 1999. At the same time, a handful of academic
and research institutions have also made efforts to
better coordinate and focus their vaccine research.
Together, these changes mark a new level of specialization and a welcome multiplicity of efforts.
Unfortunately, none of these new players or
anyone else in the field for that matter has yet to
demonstrate the ability or willingness to transcend
its own limited agenda to address the need for a
comprehensive and coordinated approach to vaccine
development. In. this regard, each and together, the
three organizations still fall short. There has been
some initial interaction around product and assay
development, as well as trial preparation, and the
HVTN will conduct a Phase 1 trial of an IAVI
sponsored vaccine. These efforts are laudable and
should grow. Even better would be coordination
that included the National Institutes of Health
(NIH), the Centers for Disease Control and
Prevention (CDC), and the Walter Reed Army
Institute of Research (WRAIR), as well as European
researchers, when appropriate.

INTERNATIONAL AIDS
VACCINE INITIATIVE (IAVI)
The goal of IAVI is to put HIV vaccines on the
global agenda by: creating global demand for vaccines; developing vaccine candidates and products
for developing countries; increasing the number of
vaccine candidates in the pipeline; increasing industry
incentives for participation in vaccine development;
and ensuring speedy, global access to any vaccine
ultimately licensed.
In the past year, IAVI's budget has grown exponentially, to $25 million, and it has just received a
five-year pledge of $100 million from the Bill &
Melinda Gates Foundation. Of the $25 million for
2001, approximately three-quarters will be used
for scientific work, including funding for five development partnerships. More partnerships are planned
for 2001, with the ultimate goal of having eight
to twelve in place. IAVI began its first Phase 1
trial in 2000.
IAVI goals for the coming year are many:
* Begin two additional Phase 1 trials (including
an oral HIV vaccine candidate).. Conduct an audit of international sites and
cohorts for vaccine trials.
* Expand primate studies and efforts to develop
standardized assays.. Hold policy meetings on demand for an
HIV/AIDS vaccine globally, and ways to
streamline regulatory procedures.

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