Meetings

Consultations

Consultation on Canadian HIV Vaccine Initiative (CHVI) Funding Programs
(February 10-12, 2008)

On February 10-12, 2008, CHVI participating departments and agencies(Canadian International Development Agency, Public Health Agency of Canada, Industry Canada, Canadian Institutes of Health Research, and Health Canada), hosted a consultation on funding programs in Ottawa.

The objective of the Consultation was primarily to seek input on three new CHVI funding programs focussing on discovery and social research; clinical trials capacity building and networks; and policy development and community engagement.  As well, the consultation provided opportunities for cross-sectoral networking and information-sharing on the CHVI.

A broad spectrum of domestic and international stakeholders attended the meeting, including representatives from Canadian and international research institutions, non-governmental organizations, the private sector, provincial and territorial governments, participating departments/agencies and other federal departments.

A key component of the meeting comprised presentations on

• Global HIV Vaccine Enterprise
• Canadian HIV Vaccine Initiative
• Global HIV Landscape

 

This was followed by intensive discussions where participants contributed expert advice on priorities and areas of focus.

The results of discussions at the Consultation will be used to inform the development of  the Request for Proposals/Application.  A final report of the meeting was published. In addition, ongoing committees; information-sharing fora and other mechanisms for the CHVI will be established. 

 

Satellite Sessions

CAS/CATIE/ICAD Ancillary Session At The 19th Annual Canadian Conference On HIV/AIDS Research

Summary Report

Prevention technologies in the broader spectrum of HIV prevention
May 13, 2010, Saskatoon, Saskatchewan

With funding from the Canadian HIV Vaccine Initiative, the Interagency Coalition on AIDS and Development (ICAD), the Canadian AIDS Society (CAS) and the Canadian AIDS Treatment Information Exchange (CATIE) hosted an Ancillary Event at the 19th Annual Canadian Conference on HIV/AIDS Research: “Prevention technologies in the broader spectrum of HIV prevention”.  This day-long satellite session brought together 39 researchers, community and public health workers, community members and government stakeholders to explore how new HIV prevention technologies (NPTs), including vaccines, microbicides and pre-exposure prophylaxis, may fit within the broader continuum of HIV prevention strategies already in use.

The objectives of the event were: to explore how new prevention technologies may fit within the current landscape of HIV prevention strategies in Canada; to identify specific stakeholder needs and capacities in the area of NPTs; and to identify the major issues that are emerging in policy, programming, research and community advocacy, and which stakeholders need to be involved in each of these areas. 

The day-long event began with small group discussions where participants identified their priorities in the area of HIV prevention technologies. The priority issues identified included community needs for research literacy and awareness; ethical issues in the research and roll-out of NPTs including potential off-label use; current challenges to prevention and the implications of NPTs for existing prevention programs, such as a potential increase in risk-taking behaviour; addressing the false separation between biomedical and social interventions; and challenges communicating about partial effectiveness.

Following the small group priority-setting discussions, presentations were delivered by experts in the field related to community concerns around access to microbicides; community preparedness and acceptance issues; early community experiences in the use of prevention technologies; perspectives from Health Canada regulators; socio-behavioural issues of new prevention technologies; and prevention technologies in context and practice.

To address the issues raised during the presentations, participants engaged in facilitated discussions on programming, policy and regulatory issues, research and community advocacy. Several issues emerged from the four tables, highlighting the needs of different stakeholders and indicating potential next steps. The issues included: the need to learn from existing prevention programs, in particular the delivery of post-exposure prophylaxis; the need to raise awareness about NPTs; the need to reach consensus on which communities will be prioritized, and to anticipate access barriers; the need to anticipate trial results and prepare media, community members and Community-based Organizations/AIDS Service Organizations for various efficacy scenarios; the need to develop a strategic plan for how NPTs would fit within broader prevention agenda; the need for resources for NPT-related research and the development of a joint research program that combines biomedical science with social-behavioural science.  From the discussions of regulatory issues it was clear that community members have many questions about the regulatory process, and what role communities can play in guiding it. 

The Ancillary Event was deemed a success according to the evaluation and several next steps were identified, and will be used to guide the work of the three implementing organizations as they advance their work in the area of HIV prevention, in collaboration with other existing networks, such as the Canadian Microbicides Action Plan Implementation

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CAS/CATIE/ICAD Ancillary Session At Leading Together: 6th Canadian HIV/AIDS Skills Building Symposium

Executive summary

Knowledge Transfer and Exchange and HIV Prevention
March 4, 2010, Montreal (Quebec)

Research and clinical trials of new HIV prevention technologies, such as vaccines, microbicides and pre-exposure prophylaxis, provide hope for more effective prevention of HIV transmission. Communities need timely, accurate information which they can use to inform and engage their members. In response to this, the Canadian AIDS Society (CAS), the Canadian AIDS Treatment Information Exchange (CATIE) and the Interagency Coalition on AIDS and Development (ICAD), in partnership with the Coalition des organismes communautaires Québécois de lutte contre le sida (COCQSida), hosted a one-day meeting in Montreal on March 4, 2010 with 74 registered participants from a variety of communities. International and Canadian presenters provided updates on research, ethics and community preparedness. The meeting was successful in achieving its objective of knowledge transfer and exchange with the following highlights:

• No single technology will fit all circumstances.
• A vaccine is possible with encouraging results from the RV144 Prime-Boost vaccine clinical trial in Thailand - a 31% efficacy rate compared to the control group. Even a vaccine of relatively low efficacy might bring about a significant reduction in the number of new infections. New vaccine candidates are being developed, including those based on antibodies isolated from volunteers with natural neutralizing antibodies to HIV.
• Treatment as prevention based on the concept that persons living with HIV who have low viral loads as a result of treatment are possibly less likely to transmit HIV is being discussed.
• Community education and research literacy are vital to community engagement, beginning in the early stages of research and continuing throughout the research process;
• Studies conducted by the University of Toronto on the social dimensions of vaccine research revealed important findings including that risk behaviours are not influenced by participation in a clinical trial.
• New prevention technologies create several challenges for AIDS Service Organizations in dealing with a possible increase in risk behaviours. Also, many ethical issues are raised and debate is needed about such questions as access, the use of medications for prevention while treatment is lacking and how to respect the individual’s right to refuse or accept treatment.

Discussions and feedback from participants revealed several main themes of concern to communities; knowledge translation and exchange, training of community educators, including persons living with HIV, partnership between communities and researchers in all stages, dissemination of results and implementation of products, engagement with the media to ensure that research is communicated in an accurate way that avoids creating stigma and discrimination.  Several suggestions to enhance KTE were exchanged including the creation of web-based information sites, use of new social networking tools and more in-depth forums on single topics such as vaccines and microbicides.

 

Health Canada/UNAIDS Ancillary Session at 18th Annual Canadian Conference on HIV/AIDS Research

Given the results of past trials and advances in the field, HIV prevention research faces a number of ethical and participatory challenges in the design and conduct of future research and clinical trials. Topics of particular concern include: community consultation in trial protocol development; the informed consent process; establishment of adequate community advisory mechanisms; and setting standards of HIV prevention and levels of care.

Hosted by Health Canada and UNAIDS, this session was led by a panel of international experts who shared evidence-based lessons learned to inform the conduct of future trials in resource-limited settings, and also to enhance awareness of two publications: The Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP); and The HIV Research Ethics Guidelines for International Settings ¹.

The objectives of the session were:

• To build capacity of Canadian researchers to undertake HIV prevention research that is grounded in a rights-based approach, in line with best practice in research ethics and community engagement;
• To share experiences using evidence-based examples and case studies to learn from previous HIV prevention trials and inform the conduct of future trials in international settings; and
• To enhance awareness of two sets of guidelines the “Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials” and the “Research Ethics Issues for HIV/AIDS Researchers in International  Settings - Perspectives from Canadian Experience”.

The panellists, in order of presentations, were:

Origin of the ethics and GPP documents and what they say about standard of prevention
Catherine Hankins, UNAIDS

GPP Pilots in twelve settings
Lori Miller, AIDS Vaccine Advocacy Coalition

Standard of prevention and standard of care
Saladin Osmanov, WHO

GCM standard of care in trials
Katie West, Global Campaign for Microbicides (GCM)

Positive Synergies in HIV Research Ethics Guidelines for International Settings
Dan Allman, University of Toronto

Standard of prevention in biomedical HIV prevention trials
Catherine Hankins, UNAIDS

Highlights of deliberations:

• The kinds of research activities highlighted by the session, such as standards of good or best practices, can evolve across time, be they standards of care or standards of prevention. It is imperative that we be prepared to shift guidance about how we do our work - and how we guide others to do theirs - accordingly.
• The community consultations on the Good Participatory Practice (GPP) Guidelines, being led by AVAC, were found to be innovative and necessary. They will be useful in revising and adapting the GPP to community "language". It appears thus far that the document is too technical and translation in other languages is also an issue.  
• As a large number of trials for biomedical HIV prevention research continue, and as more late-stage trial results are made public, there is increasing interest among Canadian researchers and advocates to learn more about this area of investigation. We need to create more opportunities and tools to raise awareness and build capacity for Canadian researchers, policy-makers and community representatives to engage meaningfully in international dialogues, community mobilization and research efforts around biomedical HIV prevention, including microbicides, vaccines, pre-exposure prophylaxis (PrEP) and treatment-as-prevention (treating the HIV-positive partner to reduce transmission).

 

There were approximately 40 participants who attended the session.

• Lori Miller presentation
• WHO/AAVP presentation
• Dan Allman presentation
• Katie West presentation

 

The Canadian HIV Vaccine Initiative (CHVI) Team Grant in HIV Vaccine Research Partnership Development Forum AIDS Vaccine 2008: October 2008, Cape Town, South Africa

The Canadian HIV Vaccine Initiative (CHVI) Team Grant in HIV Vaccine Research Partnership Development Forum

AIDS Vaccine 2008 October 2008 Cape Town, South Africa

Executive Summary

The HIV/AIDS epidemic spans the globe and continues to impact the lives of millions of people. It remains clear that the best way to get ahead of this sweeping infection is through the development and global distribution of a preventative vaccine. The recent and well publicized failures of HIV vaccine trials, though disheartening, have left the research community with a strengthened resolve to work towards this goal - each failure offering valuable insight into the final success. There is no doubt that intensifying efforts will lead to a positive outcome.

In support of international HIV vaccine discovery, the Government of Canada launched the Canadian HIV Vaccine Initiative (CHVI), a partnership between five federal departments and the Bill & Melinda Gates Foundation. This joint initiative recognizes the need for specific attention in all areas of HIV vaccine research from basic discovery to issues of ethics and social acceptance; and through the Discovery and Social Research component is launching key funding opportunities to address them. The Canadian Institutes of Health Research (CIHR) and the Canadian International Development Agency (CIDA) are working together to support HIV vaccine discovery and social research while strengthening capacity and promoting greater involvement and collaboration amongst researchers in Canada and low- and middle-income countries (low-and-middle-income country).

During a consultation session in February 2008, feedback from the HIV community in offered insight into the funding opportunities which would yield the greatest success. With the advice offered, Operating and Catalyst Grant competitions were launched in the summer of 2008. Moving forward, the focus has shifted to supporting teams of Canadian and developing country researchers with interest in research and research capacity related to the discovery of HIV vaccines and related research, such as mucosal and innate immunity, as well as social, behavioural and ethical issues including cultural and other sensitivities to HIV vaccines use and their impact on behaviour. A Team Grant Request for Applications (RFA) is expected to be launched early in 2009.

To ensure that this funding opportunity is relevant and most responsive to the needs of the HIV community, CHVI held a Partnership Development Workshop in October 2008. Held in Cape Town as a satellite session of the AIDS Vaccine 2008 Conference, the session capitalized on the gathering of international researchers to garner feedback on the draft CHVI Team Grant RFA. Over the course of the half-day workshop, participants from seven different countries heard from key players in the HIV vaccine movement, were introduced to the CHVI Team Grant funding opportunity in detail and provided input on its design. The session made it clear that a team approach to vaccine research was indeed required but that improvements were needed to increase the impact of the funding opportunity. In addition to valuable insight on administration of the RFA, the following two broad topic areas were identified as requiring additional thought:

Encouraging new and young researchers - given the current trend of thought that "New Minds, New Ideas" represent the most promising path forward in this field, does this RFA provide sufficient support to encourage new researchers into the field and to maintain existing ones; and supporting new ideas and approaches - ensuring that the objectives of the RFA include opportunities for the development of new ideas by allowing new partnerships to emerge. The CHVI partners are now in discussion to incorporate these elements and build on the recommendations stemming from the workshop into a final funding opportunity which will be released in early 2009. It is anticipated from the response and participation in the satellite session that quality applications from both social and basic researchers will be submitted to this competition once under way.

Introduction

Around the world there are approximately 4.1 million new HIV infections per year and some countries have prevalence rates as high as 25%. Research is needed in many areas of HIV/AIDS but research focused on HIV prevention is seen as a critical step in controlling the epidemic. The world needs preventative and therapeutic HIV vaccines that are safe, effective and globally accessible.

HIV/AIDS threatens the lives of many and compounds stigma and discrimination against people who are already marginalized. There are fears that without a viable vaccine, the spread of HIV could continue unabated, potentially disabling entire countries and regions, wiping out gains in socio-economic development particularly in low- and middle-income countries (low-and-middle-income country). Therefore, in the absence of a cure, HIV vaccine research and development is a pressing priority.

Background

Canadians understand that what happens globally matters locally and that Canadian research can have a global impact on preventing the spread of HIV and improving the health and quality of life of people living with HIV/AIDS. In 2007, the Canadian HIV Vaccine Initiative (CHVI) was created. This five-year collaborative initiative between the Government of Canada and the Bill & Melinda Gates Foundation represents a significant Canadian contribution to global efforts to develop a safe, effective, affordable and globally accessible HIV vaccine. Industry Canada, the Canadian Institutes of Health Research (CIHR), the Canadian International Development Agency (CIDA), the Public Health Agency of Canada (PHAC) and Health Canada are the representative federal departments involved in this initiative. Together, CIHR and CIDA are responsible for implementing the Discovery and Social Research component of the CHVI that will support HIV vaccine discovery and social research and capacity building initiatives. In keeping with the overarching CHVI principle of global access, true partnership and collaboration amongst researchers in Canada and low-and-middle-income country will be crucial for the success of these initiatives.

CIHR and CIDA are preparing to launch a Request for Applications (RFA) entitled the "CHVI Team Grants in HIV Vaccine Research" for which funding in the amount of $ 17 million dollars (CDN) will be available. Collaborative teams of Canadian and low-and-middle-income country researchers will be funded through the CIHR Team Grant program which aims to strengthen health research by supporting teams of talented and experienced researchers conducting high-quality research and providing superior research training and mentorship. The program's emphasis is on the production of new knowledge, and the translation of research findings into improvements in health and the health care system.

Proposals that represent active and meaningful partnerships between community organizations and research teams based in institutions (including universities, colleges, hospitals, and affiliated research institutions) are encouraged. The unifying element underlying all successful CHVI Teams will be a commitment to excellence and the pursuit of a problem-based, collaborative approach to health research.

Goals and Objectives of Session

Recognizing the need to develop a coordinated and focused research effort, CHVI and its partners provided a forum for researchers to meet, share experiences and prepare for this major funding opportunity. The AIDS Vaccine 2008 conference offered a unique opportunity for members of the scientific community to begin to formulate and strengthen research partnerships. Accordingly, a satellite session was held to bring together researchers from the various HIV research domains. The session was open to researchers from all disciplines and countries.

A key eligibility requirement of the CHVI Team Grant is the need for teams to include at least one low-and-middle-income country institution and at least one Canadian institution and each funded team must involve two co-principal applicants (one from an low-and-middle-income country and one from a Canadian institution) who will be directors for the program of work and share administrative responsibility for the grant. An overarching goal of this workshop was to foster these partnerships. Interested Canadian and low-and-middle-income country researchers were afforded an opportunity to meet each other and to discuss areas of common interest with a view to preparing applications for these grants. In addition to providing all participants with an opportunity to meet and network in a stimulating environment, the goals of this Partnership Development Forum were:

• To increase knowledge and understanding of the Canadian HIV Vaccine Initiative and the funding opportunities it offers for Canadian and International researchers;
• to support the researchers by providing an opportunity for them to learn more about the upcoming Large Team Grant funding opportunity;
• enhance collaboration and linkages between Canadian and low-and-middle-income country researchers and potential partners; generate opportunities for future collaboration on innovative research to reduce the global burden of HIV infection; and
• share information and solicit feedback on current research partnerships, identifying challenges and barriers to success.

It was also expected that teams of researchers would take advantage of this opportunity and begin to formulate their proposals to the "CHVI Team Grants in HIV Vaccine Research" Request for Applications to be launched in early 2009.

Speakers and Discussions

Setting the Stage - Presentations in HIV Vaccine Research

The Canadian HIV Vaccine Initiative

Steven Sternthal, Public Health Agency of Canada, Ottawa, Canada

Steven Sternthal is the Director of the Public Health Agency of Canada's Office of HIV Vaccines in Ottawa. The Office of HIV Vaccines is responsible for providing secretariat support for the multi-department/agency Canadian HIV Vaccine Initiative. Steven's work in HIV/AIDS spans over a decade with PHAC and Correctional Service Canada.

Steven Sternthal welcomed researchers and representatives from different countries and institutions and acknowledged their recognition that no one sector can solve this problem alone, and only through innovative partnerships can solutions be found. One novel partnership announced in February 2007 by Prime Minister Stephen Harper and Bill Gates is the CHVI through which Canada is doing its part to contribute to the global cause. This initiative is supported through a five-year investment of $111 million from the Government of Canada and $28 million in funding from the Bill & Melinda Gates Foundation. Within the Government of Canada, the CHVI involves several federal departments and agencies already engaged in HIV/AIDS and vaccine-related issues, including the Canadian International Development Agency, the Public Health Agency of Canada, Industry Canada, the Canadian Institutes of Health Research, and Health Canada. Partnerships and engagement are key priorities for the CHVI and mechanisms that help determine the path forward in establishing these partnerships and sharing information across the different program areas of the CHVI and across sectors are being developed.

The CHVI has four (4) funding programs which are in different stages of development -- some are in progress while others are in the consultation or development stage. These include Operating grants related to vaccine discovery, a Pilot Scale HIV Vaccine Manufacturing Facility, a Community Initiatives Fund, Catalyst grants and the focus of this satellite session - Team Grants in HIV Vaccine Research. The Canadian Institutes of Health Research and the Canadian International Development Agency are responsible for implementing this component of the CHVI which will support HIV vaccine discovery and social research capacity building initiatives.

 

An HIV Vaccine: Where Do We Go From Here?

Dr. Alan Bernstein. Executive Director, Global HIV Vaccine Enterprise, New York, United States.

Dr. Bernstein is the inaugural Executive Director of the Global HIV Vaccine Enterprise, an international alliance of researchers, funders and advocates committed to accelerating the development of an HIV vaccine. He is an internationally renowned researcher and the founding President of the Canadian Institutes of Health Research, which he built into one of the world's leading research agencies. Alan has received a number of national and international awards for his research, and has served on a large number of international scientific bodies, including the Science Board of the Grand Challenges for Global Health Initiative.

Dr. Bernstein provided an overview of the field at the moment and where it needs to go and offered an overview of the role the Global HIV Vaccine Enterprise plays in this forum.

Looking across the HIV Vaccine landscape, it is clear that profound challenges remain. From basic science issues of extensive sequence diversity to understanding the immune correlates of protection to more practical issues of limitations with animal models, limited industry engagement and political, ethical and regulatory challenges, there is much still to overcome. Failures should be treated as steps towards accomplishments and the scientific progress within each setback not overlooked or understated. Science is about a diversity of approaches and it will be important that no single scientific approach, no individual team and no one country be depended upon to solve this global problem. Areas for intensified efforts include greater understanding for the basis for long-term non-progression, better exploitation of non-human primate models as well as bringing new technologies such as systems biology, transcriptional profiling, computational biology and RNAi technologies to the forefront.

Young researchers bring energy, creativity, and new approaches to the field and we must endeavour to identify mechanisms to attract and support them in this field to ensure a sustained community of excellent investigators. In addition, investigators from countries most affected by HIV offer new insights and perspectives and should be encouraged by the provision of specific initiatives.

The Global HIV Vaccine Enterprise (GHVE) is a global partnership created by the world's leading funders of HIV/AIDS research to articulate the fastest way forward to a safe and effective preventive HIV vaccine. It creates a global community of problem solvers consisting of funders, scientists, governments, industry, and civil society, working together to devise and implement a global strategic plan to develop a safe and effective preventive HIV vaccine. The GHVE represents the HIV vaccine community by:

• Developing and maintaining the Global Scientific Strategic Plan;
• Serving as a neutral convener, catalyst, and honest broker;
• Mobilizing support for increased resources; and
• Promoting greater collaboration and coordination.

As it moves forward, the GHVE will focus on the renewal of the Global Scientific Strategic Plan, a Young Investigators Initiative, Systems Biology Initiative and a Preclinical/Clinical Research Initiative.

 

Building HIV Prevention Research Collaborations in Africa: Experience of the Canada-Africa Prevention Trials (CAPT) Network

Dr. David Moore, Research Scientist, BC Centre for Excellence in HIV/AIDS, British Columbia, Canada

Dr. Moore is a Research Scientist with the British Columbia Centre for Excellence in HIV/AIDS and an Assistant Professor in the Faculty of Medicine, Division of AIDS at the University of British Columbia in Vancouver, Canada. From July 2005 until December 2007, he worked with the US Centers for Disease Control as the Project Director and a Co-PI of the Home Based AIDS Care (HBAC) Project in Tororo, Uganda, a randomized clinical trial of different monitoring strategies for HIV-infected adults receiving antiretroviral therapy. Dr. Moore is a Co-applicant of the Canada-Africa HIV Prevention Trials (CAPT) Network and has received a New Investigator Award from the Canadian Institutes for Health Research for a CAPT Network study examining the effectiveness of antiretroviral therapy as an HIV prevention tool in sero-discordant couples.

The Canada Africa Prevention Trials (CAPT) Network was developed in 2006 with a two-year grant from the Global Health Research Initiative. Based on existing collaborations between Canadian HIV researchers and clinicians and African colleagues, the network involves five Canadian sites and eight sites in three African countries. The objectives of CAPT which reach across the two main themes of immune monitoring and prevention research capacity are:

• Building a framework for a sustainable network;
• Enhancing site capacity by providing staff, resources and training;
• Generating research; and,
• Developing collaboration with other networks.

In the nearly two years of operation, the network has established the required operational framework, established site capacity and training, begun generating research capacity and knowledge and facilitated collaborations with other networks.

Working internationally on complex problems presents special challenges that teams planning applications to the CHVI Team Grant program must consider. In the CAPT Network as with other international collaborations, the pool of HIV researchers is much smaller than in North America and those who are identified have limited time for individual projects, proposal writing or providing feedback on proposals. There is a need to train more junior researchers (i.e. Master's or PhD training rather than fellowships) and once trained, consideration to support salaried positions for researchers is necessary. Finding investigators willing and able to commit large amounts of time to African projects can be difficult without additional barriers. All countries have unique strengths and weaknesses making it impossible to apply a "one size fits all" approach to planning and implementation. There is also considerable competition for African sites with other collaborators.

Funding is a major issue with grant duration often being too short to allow real establishment of the project before it begins winding down. There is a need for continuous funding for sites beyond individual trials which would allow infrastructure investment to sustain longer term programs. Few Canadian funders have designed programs which allow funding for international projects leaving foreign NGOs ineligible to receive funding or qualify as Principal Applicants on grants. In addition, management of funds over several years is not possible with short-term funding of activities through deficit accounts and carry-over funding often not allowed.

Building prevention research capacity is a critical part of building vaccine research capacity and working as a network can greatly strengthen sites both locally by developing human and HR, physical and administrative infrastructure and globally by transforming locally relevant ideas into high quality research. Addressing the challenges presented will require sustainable long-term funding which CHVI's "Discovery and Social Research Initiative" is an important step to recognizing.

 

Overview of Team Grant RFA

Dr. Michael Grant, Division of Basic Medical Sciences, Memorial University, Newfoundland, Canada.

Dr. Michael Grant is a full professor of Immunology in the Division of Basic Medical Sciences at the Faculty of Medicine at Memorial University in Newfoundland. Throughout his career, he has studied the immunology of chronic viral infections, especially HIV infection. He has earned personnel awards and research operating funds throughout his career and is a member of the CIHR Institute of Infection and Immunity Advisory Board and Chair of the CIHR HIV/AIDS Research Advisory Committee (CHARAC).

In preparation for the luncheon discussion and afternoon feedback session, Dr. Grant provided a detailed overview of the current version of the CHVI Team Grant RFA. The Team Grant program objectives are to create internationally recognized teams of Canadian and low-and-middle-income country researchers and support their efforts to contribute important knowledge to the global search for HIV vaccines; build capacity (human and infrastructure) for HIV Vaccines discovery and related social research in Canada and in low-and-middle-income countries; create mechanisms for teams funded under the initiative to network and share information with one another and other relevant international networks and consortia; and, to create mechanisms for ongoing learning and sharing within, between and among funded teams including data sharing, shared platforms and global intellectual property access mechanisms.

It is expected that five to seven large teams will be awarded up to $600K (CAD) per year for periods of up to five years. To ensure the full range of topics are explored, at least one social science team or blended team (basic and social scientists) team and at least one biomedical/basic science team will be funded. The application process will be comprised of both Letter of Intent (LOI) and Full Application phases with teams invited to submit the full applications being eligible for $25K development grants. Teams must originate from at least one low-and-middle-income country institution and at least one Canadian institution with two co-principal applicants (one from an low-and-middle-income country and one from a Canadian institution) who will serve as directors of program. Teams may include both basic and social scientists working together or teams composed entirely of social or basic scientists.

This program is intended to support new or established teams with interest and expertise in HIV vaccine research, however; "new" teams must demonstrate that they have already developed at least an informal relationship with the intent to work together in the future. In addition to these eligibility criteria, proposals must provide training opportunities for students and young investigators in both Canada and low-and-middle-income countries.

Based on feedback received at a stakeholder consultation held in February 2008, the following priority areas for research were suggested.

In the area of social research:

• Development and evaluation of targeted communication strategies to ensure the participation of at risk groups in the design and implementation of vaccine trials;
• Monitoring the attitudes and behaviour of trial participants to assess the impact of trials on risk behaviour in communities affected by HIV;
• Investigating social issues surrounding HIV vaccines including knowledge, acceptability and access;
• Studying ethical issues related to vulnerable populations (e.g. adolescents, injection drug users, sex workers);
• Researching patent law and intellectual property issues related to HIV vaccines and related research; and
• Undertaking knowledge translation and risk communication activities related to HIV Vaccine research.

In the area of discovery research:

• Novel approaches to induction and long-term maintenance of mucosal innate and adaptive immune responses;
• Novel approaches to developing prophylactic vaccines aimed at induction of broadly neutralizing antibodies and B cell responses to HIV development and testing of therapeutic HIV vaccines;
• Studies aimed at better understanding of the correlates of immune protection relating to HIV; and,
• development and testing of novel vaccine adjuvants.

As espoused by the Global HIV Vaccine Enterprise, greater collaboration will be key to moving forward. As such, the Team Grant RFA includes requirements for ensuring that progress and results are communicated between and across funded teams. Teams are expected to gather at official meetings and symposia to share progress/challenges and have a presence at meetings of funded teams to be hosted by the CHVI Secretariat Meetings. Co-PIs and their respective teams in low-and-middle-income countries and Canada also expected to communicate with one another on regular basis. Proposals will be measured on their defined strategies for ensuring ongoing linkages within teams and between funded teams to be described within the proposal.

The same criteria which are used to review CIHR Team Grants in general will be applied to these international teams. These include:

• Proposals address an important health and disease, health care or health system problem or issue;
• Proposed research is excellent;
• Applicants' productivity, experience and training;
• Proposed team is appropriate;
• Value added of funding through a collaborative program;
• Research plan is coherent, integrated and feasible;
• Opportunities for training included; and
• Approach to research is problem-based.

In addition, the unique elements of this RFA will be judged during peer review. These include relevance and potential impact, collaboration and community involvement, technical merit, capacity building and ongoing learning.

This information was discussed over lunch by session participants who then returned to share their comments, concerns and suggestions.

Team Grant RFA Design - Feedback and Discussion

The afternoon discussion allowed potential applicants the opportunity to seek clarification and raise any concerns around shortcomings in the draft RFA. Feedback can be broken into three key topic areas.

Attracting and Retaining Young Researchers

Younger researchers do not have the established networks to form the partnerships necessary to apply for a grant under the current RFA. As a prevailing thought in HIV circles (as stated by both Dr. Bernstein during the session and by Dr. Anthony Fauci of the NIH in a recent article in Science) there is a recognition that opportunities for young investigators are few. Although the Team Grant program provides for training opportunities, authors of the RFA should also be mindful that young investigators also require support.

Supporting new ideas and approaches

The objective of the Team Grant program is to strengthen health research by supporting teams of talented and experienced researchers conducting high-quality research and providing superior research training and mentorship. The program emphasis is on the production of new knowledge, and the translation of research findings into improvements in health and the health care system. These results will be realized more rapidly and more efficiently through the Team Grant program than if the components were to be funded as a series of separate operating grants. These may be new or established teams. "New" teams must demonstrate that they have already developed at least an informal relationship with the intent to work together in the future. These grants are not intended to support the development or creation of new teams.

Questions emerged around the definition of "new" in this description and whether this program would allow emerging ideas room to be explored. Given the rapidly changing environment in HIV vaccine research, the RFA should ensure that no novel or new idea remains unexplored.

RFA Application Process and Program Delivery

Throughout the discussion, specific details regarding the application process and delivery elements were raised. These issues were based on the experiences of researchers currently engaged in other international partnerships, those knowledgeable of the Team Grant program as well as researchers new to the CIHR process. These comments and suggestions were broken down into two major groups; eligible costs and post-administration of grants. Eligible costs should allow for cohort maintenance and given the need in low-and-middle-income countries provide salary support for Principal Applicants in that country. The second discussion trend touched upon the challenges in meeting the post-administration requirements of a grant. These include ethics review and memoranda of understanding (MOU) amongst implicated institutions - both across Canada and internationally. The international nature of the teams will undoubtedly lead to extended timelines for completion and increased costs as issues such as intellectual property, technology transfer and ethics certification are resolved. Suggestions from funded researchers were to allow interim MOUs, ensure team composition includes experts in all domains, ex. Lawyers and patent experts, and to build solid contingency plans into the research plan itself. Participants urged CIHR to be as clear and detailed as possible on required elements within the RFA itself to help guide applicants during the proposal writing process.

Summary and Path Forward

The Partnership Development Forum provided a mechanism for researchers to meet with colleagues from different countries and explore the potential for international collaborations in the area of HIV vaccine research. The session allowed members of the research community the rare opportunity to meet face to face to share ideas and progress - which is one of the guiding principles of the CHVI.

Most importantly, the session offered CIHR and CHVI partners valuable insight and advice on the shortcomings and strengths of the draft Team Grant RFA. The feedback in the area of RFA design along with the observations on the application process itself will serve as a guide for the final version of the funding opportunity to be released shortly.

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¹ Health Canada provided funding through its CHVI grant programme to support the development of the Good Participatory Practice Guidelines led by UNAIDS.