Overview of the Canadian HIV Vaccine Initiative

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Overview of the Canadian HIV Vaccine
Initiative AIDS 2008 Conference Mexico City,
Mexico August 3, 2008
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Overview

• To share information on the Canadian HIV Vaccine
  Initiative (CHVI) with a focus on the current
  Government of Canada approach to
• Research and Development
• Partnerships and Engagement
• Planning

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Canadas Response to HIV/AIDS

• Domestic Response
• Federal Initiative to
• Address HIV/AIDS
• In Canada

International Response Development Assistance

• Canadian
• HIV Vaccine
• Initiative

4
Canadas Historical Involvement in Global HIV
Vaccines Efforts

• Between 2000 and 2006 Government of Canada
  invested over 93 million to support Canadian and
  international HIV vaccine research efforts
• July 2002 Government of Canada committed to
  developing an HIV vaccines plan for Canada
  inclusive of all stakeholders
• October 2005 Discussions took place with Gates
  Foundation and Canadian public and private
  sectors regarding Canadas potential contribution
  to the Scientific Strategic Plan of the Global
  HIV Vaccine Enterprise
• Spring 2006 Multi-stakeholder Canadian HIV
  Vaccine Plan Towards a World Without AIDS, was
  completed

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Canadian HIV Vaccine Initiative

• Memorandum of Understanding signed in August 2006
  between the Government of Canada and the Bill
  Melinda Gates Foundation to formalize a
  collaboration to strengthen global efforts to
  accelerate the development of HIV vaccines.
• The MOU focuses on delivering results in six key
  areas that are aligned with the Global HIV
  Vaccine Enterprises Scientific Strategic Plan
• Discovery research and capacity
• Clinical trials and networks
• Production capacity
• Policy and regulatory
• Community and social dimensions
• Planning, Coordination and Evaluation

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MOU Funding Commitments (over 5 years)

• Government of Canada 85M in newly invested
  funding 26M in reallocated FI funding
• 111M total
• Gates Foundation 28M
• Grand Total 139M
• The MOU outlines a leveraging formula of 1
  dollar from the Gates Foundation for 3 dollars
  newly invested by the Government of Canada on HIV
  vaccines related activities.

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Canadian HIV Vaccine Initiative Goals

• Coordinate Canadian domestic and international
  contribution to Global HIV Vaccine Enterprise
• Accelerate development of a preventive HIV
  vaccine
• Collaborate with key global and domestic partners

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The Global HIV Vaccine Enterprise
Funding Agencies
Scientists
Research Agencies
Shared Scientific Plan
NGOs Community groups
Biothech Pharma
International Organizations
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Scientific Priorities of the Enterprise Plan

• Laboratory standardization
• Standardization of currents assays
• (antibodies and cell-mediated)
• Development of novel assays
• Development, production and distribution
• of reagents
• Quality Assurance

• Vaccine Discovery
• Characterization of recently transmitted virus
• Immune correlates in primate models
• Design of antibody-inducing vaccines
• Design of T-cell-inducing vaccines

• Product development
• and manufacturing
• Bioprocess and analytical development
• group(s)
• - Manufacturing facility(es)

• Clinical trials capacity
• Training of research staff
• Development of sustainable facilities
• to support trials
• Expanding access to trial populations

• Intellectual Property
• Minimize restrictions on freedom
• to operate
• Sharing of information
• Recognition of contribution of partners
• -Maximize access to technologies
• and inventions

• Regulatory issues
• Harmonization of regulatory requirements
• Facilitation of decision making
• Risk-benefit assessment in decision making
• Strengthening of regulatory capacity
• in developing countries
• Ethical issues

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CHVI Guiding Principles

• Strategic coordination and integration
  alignment with the Global HIV Vaccine Enterprise
  Scientific Strategic Plan.
• Multi-partnership and engagement active
  involvement and partnerships among governments,
  private sector, academic researchers, NGOs, civil
  society and people living with HIV/AIDS.
• Accountability and transparency - multi-sectoral
  initiative implemented through open transparent
  processes
• Global Accessibility -- ensure access to future
  vaccines to people most in need (low- and
  middle-income countries)

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CHVI Horizontal Governance Structure
Minister of Health Lead Implementing Minister
Minister of Industry
Minister of International Cooperation
Potential New Partners
Gates Foundation
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Vaccine Research and Development Where does the
CHVI Fit in?
CHVI Discovery and Social Research
CHVI Pilot Scale Manufacturing Capacity for
Clinical Trial Lots
Licensure delivery
Basic research
Applied research
Small scale human clinical trials
Preclinical development
Process engineering
Large scale clinical trials
Post-market surveillance

• Scientists study the basics of HIV/AIDS and the
  immune system

• Basic research is translated into the design of
  potential vaccine candidates

• The process for manufacturing a vaccine must be
  reliable and practical. Ideally, it will also be
  inexpensive

• Vaccine candidates are screened in animals to
  determine if they are safe, elicit immune
  responses and show protection in these animals

• Phase I and II safety and immunogenicity trials
  test if the vaccine candidate elicits immune
  responses

• Phase IIb and III efficacy trials test if the
  vaccine candidate is protective

• Regulatory authorities license the vaccine after
  reviewing trial results, allowing its
  introduction (vaccine debut) for public use

• Surveillance conducted after licensure to ensure
  the continued safety of the vaccine

CHVI Clinical Trials Capacity Building and
Networks
Policy and Regulatory Issues, Community and
Social Dimensions
Planning, Coordination and Evaluation
Adapted from Ann McDonald-Cacho. Kahn, P. and L.
Long. The immune system in pictures. In Kahn,
Patricia, ed. AIDS Vaccine Handbook Global
Perspectives. New York. AIDS Vaccine Coalition.
2005. p. 36.
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CHVI Approach to R D

• The CHVI is proceeding with new funding programs
• Discovery and Social Research
• Community Initiatives Fund
• Clinical Trials Capacity Building and Networks
  Grants
• Pilot Scale Manufacturing Facility

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Partnerships, Engagement and Linkages

• The CHVI is proceeding with new funding programs
• Discovery and Social Research
• Community Initiatives Fund
• Clinical Trials Capacity Building and Networks
  Grants
• Pilot Scale Manufacturing Facility

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CHVI - Planning

• The GOC has led a number of consultations with
  stakeholders on both the Canadian HIV Vaccines
  Plan and CHVI funding programs
• Over the course of the CHVI, additional
  consultations/information sharing and planning
  meetings will be held

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CHVI - Planning

• In particular, the CHVI is planning a Partnership
  Development Forum for the October 2008 AIDS
  Vaccine Conference in Cape Town, South Africa
• The objectives of the session are to support
  potential applicants in identifying and enhancing
  collaboration and linkages between Canadian and
  LMIC researchers and potential partners as well
  as disseminating information about the funding
  opportunity itself

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CHVI Moving Forward

• The Government of Canada is committed to the
  mission of the Global HIV Vaccine Enterprise and
  is moving forward with the implementation of the
  CHVI
• Key Areas of Focus
• The CHVI will continue to develop collaborative
  networks of domestic and international partners,
  and put in place more formalized partnership
  frameworks where applicable
• By Spring 2009, there will be funding decisions
  regarding grants and contributions including the
  pilot scale manufacturing facility

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• For more information on the CHVI,
• Please visit
• www.chvi-icvv.gc.ca