Canadian HIV Vaccine Initiative

Consultation on CHVI Funding Programs

Discovery and Social Research

Global Context

Two international experts gave presentations on the global context for HIV vaccine discovery and social research.   Dr. Rafick-Pierre Sekaly from Montreal, Quebec, outlined global issues and Canada’s possible contribution and Dr. Graham Lindegger from South Africa, addressed social science considerations related to HIV vaccine trial with a focus on ethics and behaviour in trials.
 
Dr. Sekaly’s comprehensive presentation emphasized that the recent failure of the Step Trial has forced the discovery research community to step back and refocus their efforts. Important networks in this effort include CAVD, CHAVI, IAVI, EUROVAC, AAVP, and SAAVI, among others. Despite the excellent and varied research conducted by these groups and others, many questions remain about the basics regarding protection from the virus. The brightest current hope for a vaccine lies in finding a mucosal immune response since this relates to the primary transmission and reservoir for HIV.  Canada can contribute significantly to discovery research in the area of innate and mucosal immunity; the development of core facilities for standardized assays to measure immune responses; and the development of systems biology approaches. Rafick-Pierre Sékaly’s presentation

Dr. Lindegger’s presentation on Social Science Considerations in HIV Vaccine Trials - with a perspective on trials behaviour and ethics - outlined that vaccine clinical trials are by nature multidimensional and multidisciplinary because they depend on human participation and cooperation. Therefore, there is a central role for social sciences in trials - focusing on effective and ethical conduct.  Social science makes the following three primary contributions to clinical trials:

• Behavioural, social, contextual factors impacting on trials;
• Social-psychological processes in trials and the complications; and
• Interventions based on identification of these variables.

Ethics, human rights and law are all embedded in clinical trials as integral to the conduct of effective trials. Ethics has been recognized by international organizations (UNAIDS - 2000 and 2007; SAAVI; and South Africa Medical Research Council - 2003). It is also recognized that ethics is shaped by culture and context.   South Africa has focused on the concept of informed consent and its application to an increasingly adolescent population targeted in trials. Assessing the applicants understanding of the trial has been a key area of study. Graham Lindegger’s presentation

CHVI’s Discovery and Social Research Funding Objectives

A brief presentation was given on the Discovery and Social research funding stream by
Dr. Bhagirath Singh, Canadian Institutes of Health Research (CIHR).  This fund is meant to support the discovery of HIV vaccines and related research (such as immune correlates, innate and adaptive immunity, T and B cell responses, antigens, adjuvants, vectors); and social, behavioural and ethical issues in HIV vaccines. In keeping with the CHVI guiding principles, the key objectives of the component are as follows:

• Create internationally recognized teams of Canadian and low-and-middle-income country researchers;
• Support individual or small teams of Canadian investigators in their efforts to contribute important knowledge to the global search for HIV vaccines;
• Build capacity for HIV vaccines research in Canada and low-and-middle-income countries; and
• Create mechanisms for CHVI investigators and teams to collaborate with one another and other relevant international networks and consortia.

Planned CHVI funding program requirements include a combination of large team grants for teams co-led by Canadian and low-and-middle-income country researchers, along with operating grants for projects led by Canadian researchers. The next steps will include analyzing the recommendations from the consultations to lay the groundwork for the development of Requests for Application (RFAs) in 2008. The CHVI research working group and advisory bodies will assist with the RFA development and refinement. Bhagirath Singh’s presentation

Priorities for Discovery Research
 
In the area of discovery research, participants in the breakout sessions called for focus on the following:

• 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;
• Development of studies aimed at better understanding the correlates of immune protection relating to HIV; and
• Development and testing of novel vaccine adjuvants.

Priorities for Social Science Research

In the area of social research, participants in the breakout sessions called for focus on the following:

• 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;
• Investigation of social issues surrounding HIV vaccines, including knowledge, acceptability and access;
• Ethical issues related to studying vulnerable populations (e.g. adolescents, people who use injection drugs, sex workers);
• Patent law and intellectual property issues related to HIV vaccines and related research; and
• Knowledge translation and risk communication relating to HIV vaccine research.

Funding Issues and Proposed Funding Structure

Funding issues discussed by the Discovery and Social Research working group included the size of the funding envelope required to ensure a lasting effect is achieved. It was also noted that to show progress in the CHVI’s first year of operation, in addition to planning over the first five years, it will be important to consider how to have the funding renewed.  While many participants agreed that more progress could be achieved through a team-based approach rather than individual grants, there was some concern that the emphasis on teams would lead to inadequate funding for individual and small-teams of researchers.

Participants at the consultations also highlighted a need to support new investigators and novel approaches where there might not be sufficient preliminary data for them to be funded through regular CIHR competitions. 

The following funding structure model was developed by the group:

* Social, ethical and legal issues arising from discovery research

The funding structure diagram indicates the need for vertical discovery and social research initiatives, as well as cross-project initiatives that provide cross-fertilization between initiatives. Teams should consist of both a limited number of larger teams, as well as smaller innovative projects.

Project Linkages and Networking

Participants indicated that project linkages should be undertaken through CHVI secretariat- facilitated activities, including the following:

• Integrating shared areas of interest within CHVI;
• Scientific support (internal / external);
• Leveraging international collaborations;
• Regular PI meetings; and
• Annual scientific conferences;
• Data sharing mechanisms (e.g. IGLOO);
• Shared platforms; and
• Global IP access mechanisms.

Cross-Sector Input

Participants from the other funding streams identified the following two issues for consideration in implementing the discovery and social research funding stream

• Integration and rationalization of the CHVI funding streams and programs; and
• Development of an overarching CHVI strategy.