ARCHIVED - Formative Evaluation of the Canadian HIV Vaccine Initiative

CHVI Discovery & Social Research
$22 million over six years
Lead: CIHR

Purpose:

To strengthen research and research capacity focused on: discovery of HIV vaccines and related research (such as immune correlates, innate and adaptive immunity, T and B cell responses, antigens, adjuvants, vectors, etc.); and social, behavioural and ethical issues in HIV vaccines (e.g. accessibility to, and acceptability of, vaccines and cultural and other sensitivities to HIV vaccine use).

Objectives:

A key objective in this program area is to promote greater collaboration between researchers in Canada and in LMICs who are working in HIV vaccine discovery and social research. To maximize the potential for important scientific discoveries, a multi-pronged approach is being used to support creativity by both individual investigators and collaborative teams.

• Create international recognized teams of Canadian and LMIC 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 LMICs.
• Create mechanisms for CHVI investigators and teams to collaborate with one another and other relevant international networks and consortia.

Progress:

Catalyst Grants: were launched August and December 2008. 11 applications were received (7 in the first round and 4 in the second), of which 8 were funded (5 and 3). A third funding opportunity was launched in July 2009, with funding decisions not yet made on the applications. The focus of catalyst grants was on short-term seed money to support innovative HIV vaccine-related research activities resulting in the development of new proposals, tools, techniques, inventions or methodologies.

Operating Grants which were launched June 2008: 7 applications were received and 2 were funded (and an additional 3 funded through CIHR’s regular funding mechanisms). Ten more applications were received and an additional 3 operating grants, totalling approximately $1.8M, were approved under the December 2008 launch of the Operating Grant competition. The focus of these grants were on funding Canadian researchers with an interest in basic and social research related to HIV vaccines, to enhance research in HIV prevention and build future Canadian research capacity in the field.

Emerging Team Grants (for Canadian teams): Letter of Intent process was launched in May 2009. Review of applications is pending. The Emerging Team Grant was launched to address delays in the launch of the Large Team Grant. Emerging Team Grants support the work of Canadian research teams and their work to strengthen capacity, develop expertise and strategies for knowledge translation and exchange, provide a superior training and mentoring environment, and create mechanisms for individual investigators and teams funded under the initiative to network and share information with one another.

Large Team Grants (for international collaborations, funded jointly by CIHR and CIDA): The Grants were included in the original CHVI design, and were discussed at the February 2008 conference. However, the funding has not been finalized, so no Request for Application has yet been announced. The Large Team grants are now expected to be launched in the spring of 2010. Large Team Grants support teams of Canadian and Low- and Middle-Income Country (LMIC) researchers in 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 LMICs, provide opportunities for new and young investigators and create mechanisms for teams funded under the initiative to network and share information with one another.

Travel Awards: CIHR funded travel awards totalling $48,000 to facilitate six researchers’ participation in CHVI’s Partnership Development Forum during the Oct. 2008 AIDS Vaccine Conference in Cape Town South Africa.

CHVI Pilot Scale Manufacturing Capacity for Clinical Trial Lots
$61.1 million over five years from the Government of Canada and $28 million over five years from the Bill & Melinda Gates Foundation

Purpose:

A key priority for the CHVI is to contribute funds to a not-for-profit corporation (NPC) to build and govern a pilot scale facility in Canada to manufacture promising HIV vaccine candidates for clinical trials to be conducted mostly in, and for the benefit of, LMICs. The pilot scale manufacturing facility will produce clinical trial lots for HIV vaccine candidates discovered by researchers around the world. In so doing, the facility will serve as a resource for global HIV vaccine efforts in line with the principles of global access.

The establishment of the facility will help address the critical global shortage of HIV vaccine manufacturing capacity for clinical trial lots, thus contributing significantly to efforts to accelerate the development of a safe, effective, affordable and globally accessible HIV vaccine for those who need it the most. The facility will also advance Canada’s position as a centre for biomedical innovation and manufacturing, health sciences research and responsiveness to public health challenges.

Objective:

To establish a dedicated pilot scale manufacturing facility in Canada to produce HIV vaccine candidates for use in Phases I, II, III clinical trials, to be conducted mostly in and for the benefit of LMICs. The facility will be operated by a not for profit corporation (with private sector and other partners).

Progress:

Letter of Intent: To help guide the process, a consultation process with key stakeholders as held in Ottawa in February 2008. The funding opportunity was launched in April 2008 as a call for Letters of Intent. 5 Letters were received in June 2008, reviewed by an external committee of experts. Four of the applicants to the Letters of Intent process were invited to submit full applications respecting the March 2009 deadline.

Request for Applications: An external review committee examined the 4 applications in May 2009, and made recommendations to the Steering Committee. These recommendations were reviewed by the Steering Committee for the Facility and a recommendation made to not proceed with the facility. If confirmed, this is expected to be announced early in 2010.

CHVI Clinical Trials Capacity Building & Networks
$16 million over five years
Lead: CIDA

Purpose:

To strengthen the capacity of researchers and research institutions to conduct high-quality clinical trials and to build site capacity to undertake clinical trials of HIV vaccines and other preventive technologies in LMICs.

To fill a globally recognized gap in HIV vaccine clinical trial capacity as identified by the Global HIV Vaccine Enterprise, particularly in LMICs where trials are ongoing or planned; and build on the Global Health Research Initiative (GHRI) Canada-Africa HIV Prevention Trials Capacity Building Program. This component does not aim to support HIV prevention clinical trials themselves.

Objectives:

• establish or enhance collaboration between LMICs and Canadian researchers conducting clinical trials;
• enhance individual and institutional capacity in LMICs and Canada to conduct clinical trials of HIV vaccines and other prevention technologies;
• provide training or develop models, best practices and information-sharing protocols between researchers and the community;
• identify, recruit and retain cohorts of participants in LMICs, where HIV incidence and prevalence rates are high and clinical trials of HIV vaccines and other prevention technologies are planned or are ongoing; and
• examine regulatory/safety, community and social issues around HIV clinical trials.

Progress:

Completed a consultation process concerning funding priorities for this component in February 2008. IDRC will provide funds to GHRI for "Capacity Building" and "Synergy and Networking" grants. There have been delays in transfer of funds from CIDA to IDRC but CIDA has signed a grant agreement to provide $6M of the $16M previously approved (an agreement was signed January 2009). The first call for Capacity Building Grant Letters of Intent was launched in July 2009, to help applicants build on established partnerships to develop sustainable African capacity and leadership to conduct future HIV/AIDS prevention trials. This process closes in September 2009, and results are expected to be released by March 2010.

CHVI Policy and Regulatory Issues, Community and Social Dimensions
$8.46 million over 5 years
Lead: PHAC

Purpose:

To address policy, regulatory, community and social dimensions related to the development of a safe, effective, affordable and globally accessible HIV vaccine.

Objective:

• improved domestic and international policy development models, capacity and tools to address HIV vaccine-related issues;
• enhanced global access to evidence-based tools and knowledge regarding the community and social dimensions of HIV vaccine research; and
• improved regulatory capacity in LMICs, especially those where clinical trials are planned or are ongoing;
• enriched policy dialogue and discourse surrounding the legal, ethical and human rights dimensions related to the HIV vaccine;
• greater meaningful engagement and participation of local communities in all aspects of the HIV vaccine research and development continuum; and
• greater awareness amongst local communities of their rights and the benefits and potential risks associated with HIV vaccine research.

Progress:

Policy & Regulatory: Grants were awarded to WHO AAVP to strengthen the ethical-legal framework for HIV vaccine trials and to UNAIDS to support dissemination and translation to promote Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials. Grant recipients presented the results of their work in a satellite session sponsored/hosted by HC and PHAC at the Canadian Association of HIV Research Conference 2008 in Vancouver.

CIDA has received a proposal ($2M) to conduct a project to build sustainable regulatory capacity in low and middle-income countries. The proposal is currently being reviewed.

Consultations on the CHVI Policy Agenda were completed in early 2009/10. The deck was shared with all partners and the international experts who were interviewed. The input received will help shape a draft policy agenda for the CHVI which will be prepared in fall 2009.

A public-private partnership paper is in development, and a final report is expected at the end of September 2009. The paper will explain how public private partnerships could be structured to effectively engage partners.

A literature review on synergies between new HIV prevention technologies (NPTs) has been developed. The paper will assist the CHVI in defining possible linkages with other NPTs and opportunities for collaboration and knowledge exchange.

Three abstracts were submitted and accepted as poster presentations at the AIDS Vaccine 2009 Conference in Paris in October. The CHVI has also been invited to participate in a panel discussion hosted by the AIDS Vaccine Advocacy Coalition.

Community Initiatives fund launched in January 2009, with a March 2009 closing date. Two applications were received and the project has an expected start date of September. CHVI has communicated with organizations directly to obtain additional/ complementary proposals and they are expected to arrive in August. They will be reviewed and projects are expected to start in December 2009.

Planning, Coordination, and Evaluation
$3.38 million over 5 years
Lead: CHVI (PHAC)

Purpose:

To ensure effective strategic planning, scientific oversight, coordination and evaluation to meet CHVI objectives.

Objective:

• establish and maintain a governance (decision-making) structure for the CHVI;
• monitoring key trends in HIV vaccine research and development;
• enhancing Canada’s contribution to the global efforts by mobilizing expertise, partnerships, resources and liaising with domestic and international stakeholders (e.g., researchers, academics, the private sector);
• establish new partnerships and promote stakeholder engagement in the CHVI;
• raise the profile of the CHVI among stakeholders in Canada and internationally and to communicate progress.
• provide secretariat support to the CHVI, including its Interdepartmental Steering Committee and multi-stakeholder advisory committee; and
• report on progress under the CHVI.

Progress:

Helped build international partnerships and networks by attending conferences such as the AIDS Vaccine 2008 Conference in Cape Town, the XVIII International AIDS Conference in Mexico, and the BIO International Convention 2008 in San Diego (e.g AAVP, WHO, GHE, IAVI, AVAC, NIH, USAID, HVTN and Gates), and hosting the IPM and IAVI during information sessions in early 2009. In addition, members of the CHVI participating departments were invited to the United States to conduct site visits at the NIH Vaccine Pilot Plant, the Merck West Point Facility, and the Aeras Global TB Vaccine Foundation and to attend meetings with representatives from International Partnership of Microbicides, National Institutes of Health and USAID.

Funding agreement in place (July 2009) with Global HIV Vaccine Enterprise to support program delivery and the next international AIDS Vaccine Conference (CHVI will be co-sponsor of 9th Annual AIDS Vaccine Conference in October 2009).

Working with HC 's Biologics and Genetic Therapies Directorate to develop an MOU to collaborate on HIV vaccine-related issues. Under this MOU, PHAC, HC and CIDA will work together to implement a Regulatory Capacity Building Project, develop quarterly reports on global scientific trends and developments in HIV vaccine-related research, contribute expertise to the establishment in Canada of a pilot scale manufacturing facility for promising HIV vaccine candidates, and contribute expertise to global HIV vaccine regulatory-related activities under the umbrella of the Global HIV Vaccine Enterprise.

Completed the first Communications Strategy and Communications Plan