Supplementary Information Tables: 2013–14 Departmental Performance Report

Canadian HIV Vaccine Initiative (CHVI)

Name of horizontal initiative: CHVI
Name of lead department: The Agency
Lead department PAA Program: 1.2 Health Promotion and Disease Prevention
Start date: February 20, 2007
End date: March 31, 2017
Total federal funding allocation (from start to end date): $111M

Description of the horizontal initiative (including funding agreement): CHVI is a collaborative undertaking between the GC and the Bill & Melinda Gates Foundation (BMGF) to contribute to the global effort to develop a safe, effective, affordable and globally accessible HIV vaccine. This collaboration, formalized by a Memorandum of Understanding (MOU) signed by both parties in August 2006 and renewed in July 2010, builds on the GC’s commitment to a comprehensive, long-term approach to address HIV/AIDS. Participating federal departments and agencies are the Agency, HC, Industry Canada (IC), Department of Foreign Affairs, Trade and Development Canada (DFATD), and the CIHR.

The CHVI’s overall goals are to:

  • Advance the basic science of HIV vaccine discovery and social research in Canada and low- and middle-income countries (LMICs);
  • Support the translation of basic science discoveries into clinical research with a focus on accelerating clinical trials in humans;
  • Address the enabling conditions to facilitate regulatory approval and community preparedness;
  • Improve the efficacy and effectiveness of HIV Prevention of Mother-to-Child services in LMICs by determining innovative strategies and programmatic solutions related to enhancing the accessibility, quality, and uptake; and
  • Ensure horizontal collaboration within the CHVI and with domestic and international stakeholders.

Shared outcomes:

Immediate outcomes

  • Increased and improved collaboration and networking among researchers working in HIV vaccine discovery and social research in Canada and in LMICs;
  • Greater capacity for vaccines research in Canada;
  • Enhanced knowledge base;
  • Increased readiness and capacity in Canada and LMICs; and
  • An Alliance Coordinating Office established.

Intermediate outcomes

  • Strengthened contribution to global efforts to accelerate the development of safe effective, affordable, and globally accessible HIV vaccines;
  • An increase in the number of women receiving a complete course of anti-retroviral prophylaxis to reduce the risk of mother to child transmission of HIV; and
  • A CHVI Research and Development Alliance established.

Long-term outcomes

  • The CHVI contributes to the global efforts to reduce the spread of HIV/AIDS particularly in LMICs.

Governance structures:
The Minister of Health, in consultation with the Minister of Industry and the Minister of International Cooperation, is the lead Minister for the CHVI. An Advisory Board is responsible for making recommendations to responsible Ministers regarding projects to be funded and to oversee the implementation of the MOU between the GC and the BMGF. The CHVI Secretariat, housed in the Agency, provides a coordinating role between the GC partners and the BMGF.

Performance highlights: In 2013–14, CHVI, participating departments and agencies, further strengthened global efforts in HIV vaccine related research by: identifying research gaps; supporting global researchers, networks and events to increase research capacity and collaborations; and strengthening regulatory capacity of vaccine products and clinical trials. Knowledge exchange and collaboration activities were highlighted through the year as the Alliance Coordinating Office (ACO) provided opportunities for advancing HIV vaccines research, knowledge and coordination. Support was also given for research and development of an HIV vaccine and for other technologies related to the prevention, treatment and diagnosis of HIV and the development of tools and training materials for LMIC community-based interventions for prevent mother to child transmission (PMTCT) services including access and availability to treatment.

Federal partner: The Agency
PAA Programs Contributing activities / programs Total allocation (from start to end date) ($M) 2013–14 ($M)
Planned spending Actual spending Expected results Results achieved
Health Promotion and Disease Prevention Infectious Disease Prevention and Control 18.0 2.7 1.3 ER 1.1
ER 1.2
ER 1.3
ER 1.4
RA 1.1
RA 1.2
RA 1.3
RA 1.4
Total Agency 18.0 2.7 1.3    

Comments on variances: The variance is due to a $0.5M transfer of funds to CIHR through Supplementary Estimates B for HIV research (HIV vaccine and other HIV related research). In addition, the variance was also due to: a transfer of funds for other Agency priorities; staffing gaps; as well as revised timelines required for a grants and contribution application process.

Expected results and results achieved for 2013–14:

ER 1.1: Continue to support domestic and international efforts related to the research and development of an HIV vaccine.
RA 1.1: Ongoing support was provided to domestic and international stakeholders to address HIV vaccines policy issues, build capacity, promote global harmonization of regulatory pathways, and improve preparedness. Support was also provided for national and international fora attended by researchers, funders, policy makers, community stakeholders, and advocates from around the world, highlighting recent developments in vaccine research and promoting greater stakeholder engagement.

Key activities included support to:

  • The Canadian Association for HIV Research (CAHR) 22nd Annual Conference. Attendees were provided with an update on HIV vaccine research in Canada. As well, the Agency supported eight scholarships to participate in the conference and four New Investigators awards.
  • The 2013 Global HIV Vaccines Enterprise. Canadian support was confirmed for the AIDS Vaccine Conference in Barcelona in October 2013. This conference drew almost 1,000 researchers, funders, and policy-makers together from 46 countries to discuss HIV vaccines. Additionally, this support enabled 12 scholarships to be provided to LMICs which participated in the conference, as well as technical and administrative support. The Global HIV Vaccine Enterprise developed and disseminated a web tool to help researchers, funders, and other stakeholders collaborate to advance vaccine candidates into the first-in-human trials.

ER 1.2: Develop an approach to access the HIV Vaccine Translational Support Fund to provide researchers with financial and project management support for translating HIV vaccine candidates from pre-clinical development research to small scale human clinical trials.
RA 1.2: The ACO, with the support of a working group, and in consultation with partners, developed a paper outlining the various options for the development of the Translational Support Fund. These options were analyzed by the Agency and, in conjunction with meetings with CHVI partners, informed the best path forward for the fund in 2014-15.

ER 1.3: Support the continued work of the ACO to establish a strong and vibrant network of HIV vaccine researchers and other vaccine researchers both in Canada and internationally.
RA 1.3: The ACO was responsible for the following:

  • Delivery of presentations, including six webinars, to diverse national and international stakeholders to discuss scientific advances and gaps in HIV vaccine research;
  • Maintenance of a website, virtual community, and development of promotional materials to increase awareness of the Alliance and provide opportunities for collaboration and information exchange;
  • Collaboration with partner organizations to coordinate priority training opportunities for New and Early Career Investigators which resulted in three workshops and six scholarships to help support the next generation of HIV vaccine researchers and raise the priority of vaccine research training nationally;
  • Facilitation of CHVI partner information and consultation sessions to further inform funding priority areas and fund development;
  • Collaborations with global HIV vaccine stakeholders to further define and advance research and development tools;
  • Two CHVI Advisory Board meetings and four electronic votes in regards to recommendations for funding and ensuring program alignment with the MOU;
  • An Annual Meeting as a satellite session at the Canadian Conference on HIV/AIDS research in Vancouver which included 73 key HIV vaccine stakeholders; and
  • A satellite on Supporting HIV Vaccine Research and Development at the AIDS Vaccine Conference in Barcelona drew 30 participants. As well, the ACO supported a networking meeting for all Canadian HIV Vaccines researchers at this conference.

ER 1.4: Ensure effective communications, strategic planning, coordination, reporting, and evaluation within the GC.
RA 1.4: Horizontal coordination between CHVI Partners involved the communication and discussion of policy subjects on CHVI-related issues, as well as the development and dissemination of communication products and reports.

Federal partner: HC
PAA Programs Contributing activities / programs Total allocation (from start to end date) ($M) 2013–14 ($M)
Planned spending Actual spending Expected results Results achieved
Internal Services Governance and Management Support Services 1.0 Table 3 footnote 17 0.1 Table 3 footnote 17 0 ER 2.1 RA 2.1
Health Products Regulatory Capacity Building Program for HIV Vaccines 4.0 0.7 0.8 ER 2.1
ER 3.1
RA 2.1
RA 3.1
Total HC 5.0 0.8 0.8    

Comments on variances: N/A

Expected results and results achieved for 2013–14:

ER 2.1: Increased regulatory convergence and exchange of domestic and international best practices, policies and protocols related to the regulation of vaccines, with a focus on HIV/AIDS vaccines.
RA 2.1:

7th Pan American Network for Drug Regulatory Harmonization (PANDRH) Conference

HC hosted the PANDRH Conference in September 2013. The Conference was attended by 220 participants and assisted Latin American countries in the implementation of the 2014–2020 PANDRH Strategic Development Plan which, when fully implemented, will provide a clear path to increase capacity and harmonization of regulations in the region.

Contributing to international standard setting for the evaluation and regulation of vaccines

HC, as the WHO Collaborating Centre for the Standardization and Evaluation of Biologicals, supported the WHO in:

  • Developing written regulatory standards for the evaluation of biologicals;
  • Providing technical assistance in assuring the quality of vaccines;
  • Assisting in the implementation of WHO guidelines in WHO regions;
  • Participating in collaborative studies; and
  • Helping to strengthen the capacity of Low- and Middle Income Countries (LMIC) regulatory authorities.

These Collaborating Centre activities continue to be a significant contributor toward the goal of increasing global regulatory capacity and preparedness for HIV vaccine clinical trials. As an example, HC participated in the delivery of the 2013 WHO workshop for African regulators on the pre-qualification of vaccines, which was held in Burkina Faso.

Collaboration with WHO/PAHO

HC and PAHO co-organized the joint regional workshop on the implementation of WHO Recommendations for Stability Evaluation of Vaccines in Latin America in Antigua, Guatemala, in March 2014. The workshop trained regional regulators on the development of a regulatory approach for the stability evaluation of vaccines under a controlled temperature chain.

Regulatory Forums

HC provided strategic, regulatory capacity building, and technical support to the African Vaccines Regulatory Forum (AVAREF) and participated in the October 2013 meeting in Uganda. At the request of AVAREF, HC piloted the HC-developed AVAREF Virtual Collaborative Platform.
HC also actively participated in sessions at the 2013 Biennial Scientific Conference on Medicines Regulation in Africa, and the International Conference on AIDS and Sexually Transmitted Infections in Africa, facilitating exchange of best practices and regulatory harmonization.

ER 3.1: Increased regulatory readiness and strengthened capacity of regulatory authorities in LMICs in to the area of vaccine products and clinical trials through training and the establishment of a mentorship program.
RA 3.1:

Health Products and Food Branch International Regulatory Forum (HPFB-IRF)

The HPFB-IRF took place in September 2013 with over 100 participants from more than 40 countries, of which 23 participants from 15 countries were sponsored by the CHVI. Along with the WHO, HC also co-hosted a satellite workshop on Regulatory Considerations for HIV Vaccine Clinical Trial Applications in September 2013. This workshop was facilitated by a WHO consultant and included presentations from Botswana, Kenya, Uganda, and Thailand on their experiences in working with HIV vaccine CTAs. The international reputation of the HPFB-IRF continues to grow and the event was identified by regional and international partners as a significant regulatory capacity building event for their member countries to attend (e.g., WHO, PAHO, African Vaccine Regulatory Forum, etc.)

CHVI Regulatory Capacity Mentorship Program

The Mentorship Program with the Pharmacy, Medicines and Poisons Board (PMPB) of Malawi continued with HC delivering regulatory training sessions in Malawi in 2013 and early 2014. During the first session, HC expanded this training opportunity to National Regulatory Authorities in the region with similar regulatory challenges. As a result, representatives from Uganda and Zambia also attended the training sessions. Two representatives from the PMPB were sponsored to attend the 2013 HPFB-IRF to receive additional training.
HC also continued its Mentorship Program with the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria, and conducted its first training workshop in that country in March 2014. This workshop focused on two key components of vaccine regulation: submission processing/screening, and review of the common technical document. As HC promotes a regional approach to training using the existing African Vaccines Regulatory Forum network, participants from Ghana, Kenya, Uganda, and Tanzania attended as these regulatory authorities have an equivalent level of expertise to that of NAFDAC. Three representatives from NAFDAC were sponsored and attended the 2013 HPFB-IRF.

Federal partner: IC
PAA Programs Contributing activities / programs Total allocation (from start to end date) ($M) 2013–14 ($M)
Planned spending Actual spending Expected results Results achieved
Commercialization and Research and Development Capacity in Targeted Canadian Industries Industrial Research Assistance Program's Canadian HIV Technology Development (CHTD) Component 13.0 4.2Table 4 footnote 18 3.2 ER 4.1 RA 4.1
Total IC 13.0 4.2 3.2    

Comments on variances: $1M has been re-allocated internally, effectively re-profiling this amount to 2014–15.

Expected results and results achieved for 2013–14:

ER 4.1: New and innovative technologies for prevention, treatment and diagnosis of HIV in pre-commercial development are advanced at small-and medium-sized enterprises operating in Canada.
RA 4.1: Ten new CHTD contribution agreements were signed with small and medium-sized enterprises in support of research and development of an HIV vaccine and other technologies related to the prevention, treatment and diagnosis of HIV. Eight contribution agreements, encompassing early stage technology development and a Phase 1 clinical trial, have been completed, with follow-on agreements established for three of those firms.

Federal partner: DFATD
PAA Programs Contributing activities / programs Total allocation (from start to end date) ($M) 2013–14 ($M)
Planned spending Actual spending Expected results Results achieved
Global Engagement and Strategic Policy International Development Assistance Program 60.0 12.2 12.3 ER 5.1
ER 5.2
ER 5.3
ER 5.4
RA 5.1
RA 5.2
RA 5.3
RA 5.4
Total DFATD 60.0 12.2 12.3    

Comments on variances: N/A

Expected results and results achieved for 2013–14:

ER 5.1: Increased capacity to conduct high-quality clinical trials of HIV vaccine and other related prevention technologies in LMICs through new teams of Canadian and LMICs researchers and research institutions.
RA 5.1: Over the past year, the CHVIHIV Clinical Trials Capacity Building project, implemented by the Global Health Research Initiative (GHRI) ($16M over 2009–15), achieved the following results:

  • Three Master-level students graduated from their programs and 16 other students were supported in completing their Master- and Doctoral-level degrees;
  • In 10 of the 23 project countries in Africa, the skills of community members, ethics review boards, young researchers, and laboratory staff were strengthened through 28 training sessions. For example, in Nigeria, 16 civil society organizations and members of the community advisory boards were trained in research literacy, in Uganda, Tanzania, and Kenya; 150 laboratory staff were trained in good clinical laboratory practices; and in Senegal three project managers were trained in leadership and project management;
  • Collaboration between teams and institutions across Canada, South Africa, Rwanda, Botswana and the United States has been expanded. This expansion has added valuable skills to the teams’ networks, including research ethics, next generation sequencing methods, social/behavioural and community-based research;
  • Through the delivery of scientific writing workshops, 12 young researchers increased their ability to present at conferences and to publish articles specific to their work.

At the beginning of 201314, the project received a one-year, no-cost extension to March 2015 to enable capacity-building efforts to continue and be expanded.

ER 5.2:
In collaboration with CIHR, increased capacity and greater involvement and collaboration amongst researchers working in HIV vaccine discovery and social research in Canada and in LMICs through the successful completion of the development stage of the Team Grant program to support collaborative teams of Canadian and LMIC researchers.
RA 5.2: As part of a $17M project with DFATD, CIHR, as the implementing Agency, continued to administer funding for five large teams of Canadian and LMIC researchers. Over the past year, this project supported ongoing research, capacity building, and collaboration activities among researchers working in HIV vaccine discovery and social research in Canada and in LMICs.

ER 5.3: Increased number of women accessing high-quality HIV PMTCT services.
RA 5.3: DFATD supported two distinct programs to achieve this result:

1) Through the INtegration and Scaling up PMTCT through Implementation REsearch (INSPIRE) project implemented by the WHO in Zimbabwe, Malawi, and Nigeria ($20M over 2010–15), the following results were achieved in 2013–14:

  • The preliminary findings generated by the six implementation research (IR) project teams contributed to stronger national programs to prevent of mother-to-child transmission (PMTCT) of HIV in Zimbabwe, Nigeria, and Malawi;
  • Through trainings delivered by the six IR project teams and WHO country offices, over 1,700 health care workers have increased their knowledge on effective services to PMTCT of HIV;
  • Through the newly launched Implementation Research Platform (IRP) (a virtual learning network), the project has promoted information sharing and learning between developing countries; 
  • Fifteen WHO-external consultants, Ministry of Health site visits were completed which increased coordination and collaboration between the WHO, the IR project teams, and the ministries of Health;
  • All six IR teams strengthened their capacity to conduct research by participating in the second INSPIRE annual meeting, participating in specialized trainings, and by receiving technical support from WHO; and
  • The knowledge of the global HIV/AIDS community on PMTCT and implementation research was enhanced through the dissemination of the IR projects teams’ formative research findings at national and international conferences.

2) Through the Advancing Community Level Action for Improving Maternal and Child Health project implemented by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) in Zimbabwe, Swaziland, and Uganda ($10M; 2012–16), the following results were achieved in 2013–14:

  • The formative research and the community survey on knowledge, attitudes, practices, and beliefs (KAPB) were conducted, producing critical information for the next steps of the project;
  • The curriculum for the community intervention was developed and contextualized, while an adaptation workshop, training of trainers, and pilot was successfully carried out in Zimbabwe and Swaziland;
  • Ninety community leaders in Zimbabwe and 54 in Swaziland were trained. They reported a greater confidence in their ability to engage their communities around PMTCT and maternal, newborn, and child health issues using community dialogues; and
  • Data quality assessment for routine reporting was successfully conducted in all three countries, enabling the establishment of the baseline of the data using registers, monthly reports, and EGPAF’s Global AIDS System for Results database.

ER 5.4: Increased capacity of regulatory authorities in LMICs, especially those where clinical trials are planned or ongoing, through training and networking initiatives.
RA 5.4: This result has been achieved through the CHVI – Sustainable Regulatory Development to Accelerate Access to HIV Vaccines project, a project implemented by WHO ($2M over 2010–13). The project concluded in 2013 and its key outcomes included:

  • Strengthened capacity of National Regulatory Authorities (NRA) in African countries targeted for vaccine clinical trials through the formalization of the African Vaccine Regulatory Forum (AVAREF) which serves as a national resource for regulatory systems to evaluate vaccines;
  • The terms of reference for the AVAREF Secretariat were endorsed by most AVAREF member countries, and the Secretariat was established in the WHO AFRO Office based in the Democratic Republic of Congo;
  • Sixteen countries conducted vaccine clinical trials with internationally acceptable ethics and NRA approvals and oversight;
  • A strategy for incorporating the integration of ethics review, regulatory oversight, and clinical registration was implemented through the establishment of the Pan-African Clinical Trial Alliance;
  • Several of the African countries’ review mechanisms for CTAs were brought up to international standards; and
  • A cadre of qualified, skilled and experienced regulators was developed through trainings, workshops, development of guidelines, training materials, and e-learning tools.
Federal partner: CIHR
PAA Programs Contributing activities / programs Total allocation (from start to end date) ($M) 2013–14 ($M)
Planned spending Actual spending Expected results Results achieved
Health and Health Services Advances Institute Strategic Initiatives 15.0 2.8 2.9 ER 6.1
ER 6.2
ER 6.3
RA 6.1
RA 6.2
RA 6.3
Total CIHR 15.0 2.8 2.9    

Comments on variances: N/A

Expected results and results achieved for 2013–14:

ER 6.1: Greater support for new ideas, concepts, approaches and technologies by developing and launching funding opportunities in HIV vaccine research.
RA 6.1: Supported HIV vaccine research through new and ongoing funding to researchers and teams of researchers as demonstrated by:

  • New team grant funding launched in partnership with the BMGF. The focus is the prevention of HIV through mucosal infection, an emerging and critical area of investigation;
  • New funding approved for five Operating GrantsFootnote 19 , and five Bridge Grants;Footnote 20  and
  • Ongoing support for Operating Grants, Emerging Team GrantsFootnote 21, and Team GrantsFootnote 22 undertaken by Canadian and LMIC researchers.


ER 6.2:
Increased cadre of Canadian and LMIC vaccine researchers, through new investments in and ongoing support to funded CHVI investigators and teams.
RA 6.2: Support for Canadian and LMIC vaccine researchers was provided through:

  • One New Investigator Award — an HIV vaccine researcher received the award;
  • A new funding opportunity was launched offering Post-doctoral Fellowships for individuals working in the field of HIV vaccines; and
  • As part of a $17M partnership with DFATD, CIHR continued to administer funding for five large teams of Canadian and LMIC researchers. The combined DFATD and CIHR investment in the teams was $3.8M in 2013–14.

ER 6.3: Enhanced linkages and efficiencies among researchers funded within this initiative by promotion of mechanisms for networking and information sharing, such as data sharing platforms and global intellectual property access mechanisms, to support the production of new knowledge and the translation of research findings into the development, testing and availability of an effective vaccine for HIV.
RA 6.3: Supported linkages and efficiencies amongst researchers through the following mechanisms:

  • Presenting at and participating in the 2013 annual meeting of the CHVI Alliance Coordinating Office which focused on the importance of industry engagement in moving HIV vaccines from the laboratory to clinic;
  • Contributing to the ACO New and Early Career Investigator Program and New HIV Researcher Workshops which aim to increase capacity and create networking opportunities for trainees and junior investigators; and
  • Hosting a national webinar that engaged the research community in a dialogue on a new funding opportunity on mucosal immunology for HIV vaccine development as well as promoted potential collaborations and connections. The resulting funding opportunity requires teams of investigators, including at least one investigator from outside of Canada, to collaboratively address important research questions and ensure global access to research results.

Results to be achieved by non-federal partners: Non-governmental stakeholders, including research institutions and not-for-profit community organizations, are integral to the success of the CHVI. Their role is to engage and collaborate with participating departments and agencies, the BMGF and other funders to contribute to the CHVI goals and to Canada’s contribution toward global effort to develop a safe, effective, affordable and globally accessible HIV vaccine.

Contact information:
Jacqueline Arthur
Manager, Centre for Communicable Diseases and Infection Control
100 Eglantine Driveway
Ottawa, Ontario K1A 0K9
(613) 946-0822
jacqueline.arthur@phac-aspc.gc.ca


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