Global HIV Vaccine Enterprise Strategic Plan 2018-2023
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Global HIV Vaccine Enterprise
Strategic Plan
2018-2023
Foreword
The Enterprise’s 2018-2023 Strategic Plan
aims to address several pivotal questions:
How can we maintain the momentum of
scientific collaborative efforts while
orienting the vaccine community around
emerging priorities in late-stage product
development? How can we support the
vaccine space to respond optimally to
For over a decade, the Global HIV Vaccine results from current efficacy trials? How
Enterprise (the Enterprise) has played a can we best leverage the IAS’ track record
unique and essential role as a neutral in convening and engaging a diverse range
convener and facilitator, committed to of stakeholders to advance the interests of
identifying gaps and mobilizing the HIV vaccine community? How can we
stakeholders to accelerate HIV vaccine heighten political support and expand the
development. Among its many Enterprise?
achievements, the Enterprise has helped
to realize the untapped collaborative In the spirit of the Enterprise,
potential of HIV vaccine researchers and development of this 5-year strategy has
was instrumental in establishing the been a highly collaborative effort. We
Collaboration for AIDS Vaccine Discovery would like to thank the dozens of
(CAVD) and Center for HIV/AIDS Vaccine stakeholders we consulted, our Strategic
Immunology (CHAVI), two networks that Advisory Group and the IAS Governing
remain central to advancing preclinical Council, whose insights, ideas and review
and translational HIV vaccine R&D. have helped us to tackle these questions
and produce a plan that will challenge,
The International AIDS Society (IAS) is energize and inspire the vaccine
thrilled to be hosting the Enterprise as it community. We look forward to working
builds on this legacy of impact in HIV in partnership with many different
vaccine research and development. stakeholders to make this strategy a
Hosting the Enterprise at IAS will ensure reality and strengthen our collective
that the pursuit of an HIV vaccine takes a commitment towards accelerating the
place of prominence in IAS’ mission to development of an effective HIV vaccine.
reduce the global impact of HIV.
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 2Nothing has changed for the
Context Enterprise…
While the field is arguably more
collaborative than ever before, there
remains a profound need for a neutral
convener to facilitate connections aimed
at overcoming silos and tackling the field’s
most complex issues.
… and yet, everything has changed
for the Enterprise.
With multiple efficacy-stage programmes
A Bold New Era for
underway and new vaccine concepts in
the clinical pipeline, the field has built
considerable momentum toward the end
the Enterprise goal. This sense of possibility is matched
only by a growing sense of urgency that
The alliance of funders and stakeholders the field remains inadequately prepared
that established the Enterprise over a for the final—and most complex—leg of
decade ago understood the potential to the vaccine development journey. There is
accelerate HIV vaccine development now a need for an Enterprise committed
through coordination, collaboration, to fueling dialogue, developing resources
knowledge-sharing and mobilization of and facilitating solutions that help the
resources. Today, as the Enterprise field maintain product development
transitions to the IAS, we have an momentum, plan for success and diversify
opportunity to affirm the Enterprise’s the coalition of partners critical to
mission in the context of a transformed achieving the end goal.
landscape—and to engage new
stakeholders and funders in a diversified, This document describes the context and
resilient and truly global alliance framework for the Enterprise’s new five-
relentlessly committed to developing an year strategy. We begin with an overview
HIV vaccine as quickly as possible. of the field’s critical issues.
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 3We Need Even More
characteristics, including efficacy levels.
Developers will need to create
manufacturing capacity, either directly or
Collaboration through technology transfer to third
parties, to ensure stable, cost-effective
Vaccine Candidates Face a Complex vaccine supply. Finally, access will hinge
and Uncertain Path to Market on stakeholder engagement and careful
planning to identify target populations,
The field is enjoying an unprecedented forecast demand and determine optimal
level of late-stage clinical activity, with deployment channels—challenges that
Figure 1. HIV Vaccine & Biologics multiple vaccine efficacy trials underway may be exacerbated by the multi-dose
Efficacy Trials (P5, Janssen) or soon to begin (PrepVacc) regimens currently in development.
in southern Africa (Fig. 1). In parallel,
HVTN 703 and 704 are assessing passive Planning for and enabling the success
immunization of a broadly-neutralizing of late-stage candidates will require
antibody (bNAb). While exciting, these broad stakeholder engagement and
trials are exposing gaps in the field’s alignment to clarify and accelerate
ability to respond to and prepare for the the path to market.
realities of late-stage development.
Strengthening the Pipeline Will
First, conducting efficacy trials in the
future will be challenged by the evolving Require a Focus on Scientific Gaps
nature of the epidemic. As use of pre- Early-stage HIV vaccine candidates align
exposure prophylaxis (PrEP) and other with a few high-level strategies (eliciting
prevention tools increases and HIV bNAbs, stimulating non-neutralizing
incidence declines, the cost and antibodies or inducing T cell-mediated
complexity of vaccine trials will rise in control of HIV) based on current (and
order to maintain statistical power. incomplete) knowledge of the potential
Second, several issues must be tackled to capacity of the immune response to
set the stage for future vaccine access. protect against HIV infection. To improve
There is a need to build local regulatory and diversify the range of concepts in the
capacity for licensing an HIV vaccine in pipeline we need to improve our
high-incidence countries and to understanding of immunology and
understand policymakers’ desired vaccine optimize preclinical research tools.
Data Source: AVAC
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 4It will be critical to learn more about dollars) for the past decade, and ~85% has
immune responses—including mucosal come from the US Government and the
immunity, microbiome responses and Bill & Melinda Gates Foundation (BMGF;
bNAb generation, among others—and Fig. 2). The field will need more resources
determine which responses are correlated to accelerate progress and support early-
with vaccine-induced protection. With and late-stage R&D efforts.
late-stage programmes planning
Attracting funding will require knowledge
correlates analyses following efficacy
of the objectives of various (potential)
readouts in 2021-2022, there is an
funders. Some governments have been
opportunity for the field to prepare for
reluctant or unable to fund HIV vaccine
sharing and interpretation of results to
R&D due to other priorities taking
inform early-stage vaccine efforts.
precedence or to constraints related to
There is also a need to increase the integrating HIV vaccine work within
predictive accuracy of animal models and broader HIV or infectious disease
Figure 2. HIV Vaccine R&D Funding continue to improve and standardize portfolios. International development
(US$ Millions) immune response assays. And while the agencies are often focused on community-
field has benefited from research and based programme delivery and may not
clinical networks in the US and Europe, have latitude or appropriate vehicles to
there is still room for increased invest in HIV vaccine R&D. Most industry
collaboration, information-sharing and players have not invested substantially,
exchange of vaccine components. especially before efficacy readouts, given
the perceived lack of commercial
Fortifying the pipeline will require potential—though Janssen’s pursuit of a
field-wide innovation and increased ‘global’ vaccine could transform this view
collaboration to encourage diverse and stimulate wider industry funding.
approaches, including ‘mixing and
matching’ vaccine components. Stakeholders must work together to
optimize resource use and to
Funding Has Been Stagnant and increase funding and broaden the
Shouldered by Only a Few Funders support base by aligning investor
Data Source: AVAC
priorities with potential impact.
Other includes European Commission, Ragon Foundation, Funding for HIV vaccine R&D has been
Swedish Research Council, ANRS, UK MRC and industry. relatively flat (and thus declining in real
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 5Focusing the Enterprise on Areas of Greatest Unmet Need and Potential Impact
Engagement with stakeholders has sharpened our focus on critical issues that would benefit most from greater co-ordination, invigorated
collaboration and facilitated, multi-stakeholder approaches (highlighted cells; Fig. 3).
Figure 3. Priority Issues in the HIV Vaccine Field
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 6The Enterprise Has a Figure 4. Enterprise Strategy in the Context of Study Timelines
Timely Opportunity to
Support a Complex
Ecosystem
The Enterprise’s 5-year strategy coincides
with the completion of several vaccine and
biologics efficacy trials (Fig. 4), sharpening
our focus on helping the field prepare for
potential outcomes and respond to the Data Source: AVAC; PrEPVacc estimated start date is approximate
knowledge, opportunities and
expectations these studies yield.
Stakeholders across the HIV vaccine Figure 5. A Diverse Ecosystem Tackling Field-wide Priorities
ecosystem are working to address many of
these priorities (Fig. 5) and the Enterprise
has an opportunity to amplify and
accelerate mutually reinforcing efforts by
fostering co-ordination and collaboration
and helping the field work together as
effectively as possible.
N.B. Selected logos are illustrative and do not reflect
the dozens of academic institutions and groups
contributing to HIV vaccine R&D. Activities associated
with HVTN, AVAC and WHO represent examples of
ongoing work to address field-wide priorities. CHAVI
(later CHAVI-ID) will be re-established as the Consortia
for HIV/AIDS Vaccine Development (CHAVD).
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 7A Renewed Sense of Mission
The transition to IAS is an important milestone for the Enterprise and an opportunity
to reaffirm our mission and realign our focus to meet the needs of a field that has
changed dramatically since our formation over a decade ago.
The next section provides an outline of our updated, 5-year strategic framework,
which has been designed to ensure that the Enterprise is optimized to support the
most critical issues, risks and challenges faced by the field.Our Strategy
A safe and effective
vaccine available to OUR AMBITION
the world: This is the The Global HIV Vaccine
Enterprise unites
vision that inspires stakeholders to share
the Enterprise. knowledge, foster
collaboration, enable
Attuned to the challenges of the field
today, the Enterprise aspires to support a solutions and expand
global alliance of stakeholders to achieve a support critical to the
common vision: a safe and effective HIV
vaccine that is available to the world. development of—and
To this end, our 5-year ambition future access to—an HIV
emphasizes the Enterprise’s critical role in
bringing stakeholders together to address
vaccine.
the needs, risks and complexities critical
to accelerating HIV vaccine development.
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 9Our Commitments
The Enterprise recognizes that the needs
of the HIV vaccine field will evolve over
the next 5 years, and it will work through
To realize this ambition, we will build on ongoing stakeholder engagement and
the Enterprise’s proven and enduring role with strategic guidance from the
as a neutral convener that brings Enterprise Advisory Group (comprised of
stakeholders together to tackle critical leading HIV vaccine experts, funders and
issues (see ‘The Enterprise Approach’ stakeholders who represent the field’s
box). Over the next 5 years, we will needs, priorities and diversity) to identify,
concentrate our efforts on the pursuit of prioritize and invest in activities with the
three pivotal COMMITMENTS: greatest potential for impact.
1. PROPELLING THE VACCINE We will build momentum in year one by
PIPELINE focusing our efforts on NEAR-TERM
Strengthen strategies to align, amplify and ACTIVITIES. Activities will be sequenced
accelerate development of candidate strategically and annual implementation
vaccines. plans—with detailed activities, timelines
and deliverables—will be developed to
2. PREPARING FOR SUCCESS direct and monitor our efforts.
Tackle priorities essential to clarifying the
roadmap for future access to a vaccine. Our commitments are also associated
with GUIDEPOSTS (pages 11-13) describing
3. EXPANDING RESOURCES & immediate and intermediate Enterprise-
ENGAGEMENT driven outcomes as well as field-wide
Enlist a diverse community of partners to IMPACTS (page 14) against which we can
support and contribute to the field. help monitor and report on to gauge the
field’s progress over the coming years
Each commitment will be advanced by
(page 14).
two GOALS that provide focus for
Enterprise-led activities, while preserving On the next page we present a high-level
flexibility to work with the broader HIV illustration of our strategic model. The
vaccine community in defining how the ‘hub and spoke’ architecture is meant to
Enterprise’s specific contribution can add convey the spirit of collaboration that
the greatest value. underpins our work and is instrumental to
the success of the HIV vaccine field.
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 10Our Strategic Framework Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 11
Commitment 1 models, immune assays) and in designing
and refining vaccine concepts, particularly
PROPELLING THE if correlates of protection are validated.
VACCINE PIPELINE This commitment will help to fortify
partnerships by reinforcing a common
Strengthen strategies to align, amplify and product development language; nurturing
innovative vaccine concepts; and
accelerate development of candidate
supporting future vaccine trials.
vaccines.
GOAL 1.1 Tackle issues in trial design
The Enterprise can help the field maintain
and implementation. Working with trial
scientific, pipeline and product
networks, communities and policymakers,
Near-Term Activities development momentum in the context of
and aligning with complementary efforts,
unprecedented late-stage clinical activity.
• Review existing incidence and PrEP uptake we will foster collaborative solutions to
data and develop plans to increase Two issues are particularly salient.
sustain the field’s ability to conduct
understanding of and sustain dialogue First, as the evolving prevention landscape efficient clinical trials in an evolving
around the impact of prevention modalities
transforms the dynamics of the epidemic prevention landscape.
on vaccine development and testing.
worldwide, vaccine trials are becoming
GOAL 1.2 Enhance product
• Assess available resources and develop an more complex. We must prepare for and
integrated PD education programme. development knowledge and
adapt to new ethical, epidemiological and
collaboration. We will host workshops
Guideposts clinical realities that will drive trial design
and toolkits that sharpen the field’s
and implementation to ensure that
• Diverse stakeholders accessing events, tools product development mindset and enable
promising vaccine candidates efficiently
and information to enhance PD knowledge. the scientific dialogue needed to promote
reach advanced stages of development.
• The field is increasingly accessing Enterprise- collaborative efforts around novel
hosted resources to support trial design. Second, with diverse stakeholders combinations of concepts/components
(industry, academia, government, NGOs) and improving research tools.
• Stakeholders are developing frameworks and
contributing to HIV vaccine development,
toolkits and reaching consensus to guide PD.
we must strengthen knowledge-sharing to “All the science in the world doesn't
• Funders/developers are integrating enrich the field’s product development get you a vaccine… It’s the end
knowledge of the global pipeline into
portfolio decisions.
mindset, identify synergies of effort and game you have to think about.”
foster more collaboration—most notably
—Vaccine R&D Leader, Industry
• Collaborations are emerging to test new in learning from trial outcomes,
vaccine concept/component combinations. improving research tools (e.g. animal
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 12Commitment 2 efficacious HIV vaccine readily available
for the populations that need it most.
PREPARING FOR GOAL 2.1 Clarify regulatory and access
SUCCESS pathways. Working with the WHO,
regulators, policymakers, communities
Tackle priorities essential to clarifying the and product developers and funders, we
will facilitate mapping of regulatory and
roadmap for future access to a vaccine.
licensure pathways for an HIV vaccine and
With late-stage vaccine programmes help advance efforts to forecast demand
anticipating efficacy results in 2021-2022, and define deployment channels. Initial
there is a critical need to mobilize now to efforts in this area may focus on Sub-
prepare for all potential trial outcomes, Saharan Africa as it is the epicenter of the
including vaccine efficacy scenarios. The epidemic and efficacy trial activity.
Near-Term Activities Enterprise has an important role to play in
GOAL 2.2 Devise new business models
helping the field align on strategies to
• Engage efficacy-stage programmes to define overcome potential barriers to licensure, for late-stage product development.
common access planning challenges. We will convene diverse stakeholders—
scale-up and access to a safe and
• Convene stakeholders to discuss ideas for
product developers, industry, research
efficacious vaccine.
catalyzing new funding models. funders, international finance and
Preparing for success means planning for development agencies, the investment
Guideposts any outcomes of current and future trials; community, local and regional
• Stakeholders view the Enterprise as an understanding regulatory pathways— authorities—to catalyze dialogue around
important partner in mobilizing ideas and particularly in countries with limited novel business models that address the
solutions around vaccine access. capacity for and experience with vaccine imperatives and risks of late-stage HIV
• Stakeholders are engaged in dialogue on licensure; aligning on preferred product vaccine R&D, scale-up and rollout.
licensure pathways and capacity-building, characteristics to focus product
beginning in Sub-Saharan Africa. improvement efforts; developing access “Scoping out what would be
• The field has defined a target product profile
strategies aligned with regional needs and required—and designing business
that reflects health system and community
resources; and identifying ways to models to fund it—if successful
priorities.
encourage at-risk investment needed for
manufacturing scale-up and deployment.
results emerge from efficacy studies
• Perspectives on potential business models would be very meritorious.”
for late-stage vaccines have been This commitment will help to ensure that,
—Leader, HIV Vaccine Product
documented and are driving action. as a field, we are ready to make a safe and Development Partnership
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 13Commitment 3 critical to our capacity to design, incubate
and scale programmes that create value.
EXPANDING When we are successful, the field will be
RESOURCES & propelled by a broader pool of committed
funders and by an Enterprise that is
ENGAGEMENT widely recognized for helping diverse
stakeholders achieve greater impact.
Enlist a diverse community of partners to
support and contribute to the field. GOAL 3.1 Strengthen political
commitment and encourage new
Expanding and diversifying investments in
investment. We will bring scientific
HIV vaccine R&D remains a key priority rigour to collaborative advocacy efforts
for the field. The Enterprise has a role to aimed at influencing political priorities;
play in engaging new funders, making the
driving greater investment in HIV vaccine
scientific case for investment and
R&D; deepening engagement with a range
mobilizing political commitment. of potential funders in the EU, Asia and
Near-Term Activities beyond; and working toward ensuring
Unlocking new funding for the field is
• Build on 2018 Stakeholders’ Meeting to that industry’s seat at the table fosters
complex and dependent on the efforts of
create a platform for sustained engagement. opportunities for collaborative action.
multiple actors. The Enterprise will work
• Work with advocates to align on approaches closely with the IAS Resource GOAL 3.2 Diversify engagement and
to reinforce and amplify case for investment. Mobilization team and partners to apply expand collaborative action. We will
focus, create venues for information- engage relevant stakeholders in designing
Guideposts
sharing among current and potential and delivering programmes that reflect
• The field is supported by a broader funding funders, and amplify the case for support. diverse priorities, perspectives and
and partner base and growth in total contributions, advance opportunities for
resources. As the Enterprise, we will ensure that our collaboration and optimize resources.
• Industry is an increasingly active participant programmes tackle issues of foremost
in Enterprise programmes and initiatives. priority for funders and the field, “There is a role for scientific
positioning the Enterprise as an essential
• Europe, Asia and Latin America are more advocacy... I don't think we can
partner in mitigating risk, aligning
engaged in Enterprise programmes.
fragmented efforts and amplifying the
have too many people saying the
• Industry’s contribution to vaccine potential of finite resources. Enhancing world needs an HIV vaccine.”
development is growing. engagement in the Enterprise will be —Leader, Vaccine Research Institute
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 14Impact
Over the past decade, the Enterprise has
played an important role as a neutral
convener to accelerate HIV vaccine R&D.
Our 2018-2023 Strategic Plan recognizes
the enduring need for a neutral
convener—and it emboldens this role by
positioning the Enterprise to help the field
tackle key challenges, including preparing
for the possibility of success while
sustaining innovative product
development momentum.
Our plan will support collaborative
solutions to enable three field-wide
impacts against which we—and other
stakeholders—will measure the field’s
progress: a ROBUST PORTFOLIO of promising
vaccine concepts; ENHANCED READINESS for
the path forward for a successful vaccine;
and DIVERSIFIED FUNDING for the field.
Our success will enable the field to build
on available data to advance the most
promising vaccine concepts and make the
best use of resources. Product developers,
regulators and health systems will be
ready to make a successful vaccine
available to populations that need it most.
And the field’s R&D priorities will be
propelled by an expanded community of
engaged funders, partners and donors.
Global HIV Vaccine Enterprise: 2018-2023 Strategic Plan 15This is a unique and exciting moment for the HIV vaccine development field,
characterized by renewed momentum and unprecedented promise for the
development of a vaccine. This Strategic Plan will solidify the Enterprise’s
value to the field and propel our shared vision to develop a safe and
effective HIV vaccine available to the world.You can also read
