Canadian HIV Vaccine Initiative

Consultation on CHVI Funding Programs

Setting the Context

Introduction

In February 2007, the Canadian HIV Vaccine Initiative (CHVI) was established.  The CHVI is a collaboration between the Government of Canada and the Bill & Melinda Gates Foundation. Within the Government of Canada, the CHVI involves several federal government departments and agencies already engaged in HIV/AIDS and vaccine-related issues, including the Canadian International Development Agency (CIDA), the Public Health Agency of Canada (PHAC), Industry Canada (IC), the Canadian Institutes of Health Research (CIHR), and Health Canada (HC).

Canada takes a comprehensive and long‑term approach in the global fight against HIV/AIDS. The CHVI was created as Canada's contribution to the Global HIV Vaccine Enterprise, as part of a global commitment to accelerate the development of safe, effective, affordable and globally accessible HIV vaccines.

The CHVI is guided by the following four principles: strategic coordination and integration; multi‑sectoral collaboration and engagement; promotion of human rights and global access; and accountability and transparency.  These principles are critical to the successful achievement of the CHVI=s overall goal of coordinating domestic and international HIV vaccine efforts to support the Global HIV Vaccine Enterprise.

The Consultation on CHVI Funding Programs was hosted by the CHVI=s participating departments and agencies on February 10-12, 2008, at the Westin Hotel in Ottawa, Ontario. This consultation is part of an ongoing process of stakeholder engagement on HIV vaccines.  Between 2003 and 2005, many key Canadian stakeholders worked together to develop a vision for action on HIV vaccines in Canada.  The Canadian HIV and Vaccines Plan was developed as a result of these extensive consultations.  This comprehensive plan identified challenges and made recommendations, some of which were the key motivators for the development of the CHVI.  The Consultation on CHVI Funding Programs is an important step forward as we collectively work together to further the work of this initiative. 

Consultation Approach and Objectives

Approximately  80 participants with expertise in HIV/AIDS attended the consultation, including a broad spectrum of domestic and international stakeholders from Canadian and international research institutions, non‑governmental organizations, the private sector, provincial and territorial governments, participating departments/agencies and other federal departments.

In keeping with the spirit of the CHVI principles, the objectives of the February meeting were to share information on the CHVI=s implementation, including new funding programs, coordination mechanisms, and opportunities for involvement of domestic and international stakeholders.  A key goal was to obtain input on CHVI funding programs designed to focus on the development of important program elements for those departments and agencies providing leadership to the CHVI.  The event was also a venue for cross‑sectoral networking and information sharing.

The consultation opened with an overview of international HIV efforts and the CHVI.  A subsequent plenary session showcased the expertise in HIV of various participants from the United States, South Africa and Canada.  The speakers provided informative presentations on the global context in the following theme areas:  discovery and social research, clinical trials capacity building and networks, and policy development and community engagement.  In the breakout sessions that followed, participants had an opportunity to share perspectives and provide input on how Canada can contribute to international HIV vaccine efforts through the CHVI in the following three program funding streams: discovery and social research, clinical trial capacity building and networks, and policy and community engagement. 

The input obtained throughout the consultation is summarized in this meeting report.  It will feed into the process for developing requests for proposals/ applications/invitations to access CHVI funding via participating departments and agencies. It will also be the basis for the CHVI Steering Committee to establish advisory committees, and information-sharing fora and other mechanisms.  It is important to note that input rather than consensus was sought from stakeholders.

Update from the Global HIV Vaccine Enterprise

To open the consultation, Dr. Alan Bernstein, Executive Director, provided an update on the Global HIV Vaccine Enterprise.  The Enterprise was created to encourage/champion HIV vaccine discovery research; share scientific plans; increase resources; and enhance collaboration to hasten the search for an effective HIV vaccine. 

Dr. Bernstein emphasized that the global perspective is central to the CHVI.  The toll of human suffering from HIV is a crisis of unprecedented human proportions and, as with other infectious diseases, the best way to end the pandemic is through the discovery of a vaccine.  Developing an effective HIV vaccine is as difficult a prospect today as it was 25 years ago.  This challenge – promoting discovery research to turn global problems into global solutions – is what led Dr. Bernstein to accept his current position with the Enterprise. 

The Enterprise has adopted an inclusive approach to developing an HIV vaccine on a global scale, which is driven by science, stakeholders, industry, and people living with AIDS.  By drawing together excellence in all areas across the vaccine development continuum, the Enterprise has created a nucleus from which to develop and coordinate an effective plan.  This consultation is an important next step in determining how Canada can best assist in the Enterprise’s work.

The Enterprise’s “Scientific Strategic Plan” is central to the Enterprise’ activities and focuses on the following six main areas:

• Vaccine Discovery;
• Laboratory Standardization;
• Product Development and Manufacturing;
• Clinical Trials Capacity;
• Regulatory Capacity; and
• Intellectual Property.

Work needs to be initiated to stimulate discovery research; determine how to compare clinical trials; and establish laboratory standards.  There is an urgent need for enhancing clinical trials capacity in Africa.  For regulatory capacity, harmonization is needed.  Work also needs to be undertaken on intellectual property.  To achieve this vision, the active participation of biopharmaceutical companies with a proven track record in vaccine development is needed.  In summary, we need to establish collectively where people can fill gaps and identify new discoveries that can be capitalized on to stimulate the best kind of research. Dr. Bernstein’s intention is to establish an active secretariat in New York in which he would like Canada to play a key role.  The development of a pilot scale clinical trial lot manufacturing facility in Canada is addressing an important element within the Enterprise’s work.

The Enterprise seeks to act as a convener in addition to offering a collective vision on how to best address HIV/AIDS, by harnessing new opportunities for HIV vaccine through collaboration, strategic focus and increased resources. Alan Bernstein's presentation

Key International Initiatives and Trends

The consultation was designed to reflect the importance of networking across functional areas and to maximize opportunities to engage with participants from a wide range of specializations.  To further increase collective knowledge of the national and international landscape on HIV vaccine initiatives and to provide an opportunity to network, each participant, during a small group discussion, was asked to make a short list of key international trends and issues identified within the context of the CHVI.  Forty-two trends and issues were identified by participants and were subsequently grouped into the following five thematic categories: HIV vaccine research, treatment integration, collaborative research, access issues, and regulatory policies.

HIV Vaccine Research

It was agreed that the timeframe for the discovery of an effective HIV vaccine is years away, notwithstanding the fact that we live in a world that demands instant results/gratification. Participants’ statements reflected varied views, including public perception about HIV research and funding.   Viewpoints ranged from the need to focus on innovation; application of current vaccine research strategies versus application of new technologies; and resource limitations that impinge upon the appropriateness of deciding between discovery research and clinical trials. 

Some participants indicated that innovation is the way of the future and they continue to promote upstream research and increased dedicated funding.  However, the viewpoint of spending research dollars only in areas showing the most progress runs the risk of backing only one approach.  Resource availability becomes an issue when determining which candidates to move forward and in deciding whether to sacrifice discovery research for clinical trials.  Others indicated that there is an ongoing tension between existing coverage/uptake of current vaccines versus new technologies, as well as a decline in interest in HIV vaccine trials by bio-pharmaceutical companies due in part to the recent failures in HIV vaccine research, such as the Merck trials. 

Although there is confidence in new data on the HIV epidemic, delegates indicated that public perception of HIV vaccine research is shifting.  There is a perception that there is over-funding of HIV/AIDS versus funding other important health issues and that there is potential for scientists, funders and volunteers to look for other tasks.  At the same time, HIV vaccine research becomes less important in light of positive discoveries in other areas and when there are competing demands (i.e. avian influenza/pandemic).  As such, there is a need to sustain hope and community/political interest to focus on HIV vaccine research.

Treatment Integration

Participants expressed the viewpoint that vaccines should form part of a comprehensive approach rather than a stand-alone/isolated modality and that vaccination, prevention and therapy/treatment should be integrated into one continuum.

Collaborative Research

Collaboration between developed and developing countries was identified as essential for tackling global HIV vaccine development and testing.  Collaborative participation is gaining increased popularity among countries and organizations, and is increasingly being used as an avenue for information-sharing between international organizations, and governments.  International collaboration will strengthen efforts in vaccine development and testing.  Amidst the international collaborations, as well as numerous initiatives and programs, such as the EDCTP, IAVI, CHAVI, CAVD, CHVI has to ensure that it finds its niche. 

Access

Although access is a global problem, it is more pronounced in developing countries, where AIDS is most prevalent.  Women often face distinct barriers in accessing HIV prevention, care, treatment and support services.  As well, cultural differences affect how people in need are located and invited to participate in clinical trials.  Even in the developed world, there are challenges of accessing the hard-to-reach groups (sex workers, people who use drugs).  Additionally, the failure of the Merck trials has resulted in decreased developing country participation in clinical trials. 

Regulatory

The delegates highlighted the fact that regulatory preparedness is not as advanced in developing countries as in developed countries.   In countries hosting clinical trials, it is imperative that regulatory frameworks be in place to guide the trials.  Regarding the production of vaccines, increased regulatory requirements are needed to guide the development of new products.

Overview of the CHVI

Dr. Frank Plummer, Director General, National Microbiology Laboratory, spoke about the creation of the CHVI and the unique partnership formed between the Government of Canada and Bill & Melinda Gates Foundation.  The Gates Foundation’s leadership has been important in advancing global efforts to working together to address development challenges.  In October 2005, industry representatives, federal government departments and the Gates Foundation met to explore the Canadian contribution to the Global HIV Vaccine Enterprise’s Scientific Strategic Plan.  At that meeting, Canada’s expertise across all sectors was recognized, and the Gates Foundation expressed an interest in partnering with Canada to address gaps in the Plan.  In particular, the clinical trial lot manufacturing facility was identified as a high priority for the Gates Foundation.  A Memorandum of Understanding was subsequently signed by Bill Gates and Prime Minister Harper in February 2007, which led to the creation of the CHVI.

A CHVI Interdepartmental Steering Committee comprised of Directors General from participating departments and agencies was formed to lead the initiative. The CHVI builds on the Government of Canada's commitment to a comprehensive and long-term approach in the global fight against HIV/AIDS, and, in particular, to support the development of new HIV preventive technologies. The design of the CHVI was influenced by the development of The Canadian HIV Vaccines Plan and the emergence of the Global HIV Vaccine Enterprise’s Scientific Strategic Plan.  It is closely aligned with the goals of the Federal Initiative to Address HIV/AIDS in Canada and with CIDA's support of research-based solutions addressing the health needs of developing countries. The CHVI also complements Canada's efforts through the Global Health Research Initiative and lends support to innovative R&D partnerships, such as the International AIDS Vaccine Initiative, the African AIDS Vaccine Programme, and the International Partnership for Microbicides.  

Based on discussions with the Enterprise and recognizing Canada's existing strengths, the CHVI identified the following priority areas:

• Discovery and Social Research
• Clinical Trial Capacity Building and Networks
• Pilot Scale Manufacturing Facility in Canada for Clinical Trial Lots
• Policy and Regulatory Issues/Community and Social Dimensions
• Planning, Coordination and Evaluation

The CHVI will engage in a wide range of relevant strategies to communicate its goals and objectives and create international linkages to maximize available networking opportunities, as well as develop the necessary mechanisms to foster integration in Canada.  For the immediate future, the CHVI will focus on raising its profile through Ministerial opportunities and upcoming conferences and Global Enterprise fora.  A key objective of the CHVI is to ensure a cohesive strategy with various funding streams that are accessible to eligible recipients.  Requests for proposals/applications/invitations to submit applications for CHVI funding programs will  developed to initiate the disbursement of funds. In addition, to foster partnerships, engagement and linkages advisory committees, information sharing fora and other mechanisms will be established. Frank Plummer’s presentation