Canadian HIV Vaccine Initiative

Frequently Asked Questions

Note: Some information on this page is courtesy of the International AIDS Vaccine Initiative .

General

Why do we need an HIV vaccine?

HIV/AIDS is a disease of grave global proportions and has appalling human and socio-economic impacts. More than 25 million people have already succumbed to HIV/AIDS, and the epidemic continues to grow in all regions of the world. UNAIDS and the World Health Organization (WHO) estimate that about 2.5 million people were newly infected with HIV in 2007, including 1,200 children a day. An estimated 33.2 million people worldwide, many of them in parts of the world where access to care, treatment and support is inadequate or non-existent, are now believed to be living with HIV/AIDS.

A safe, effective, affordable and globally accessible preventive HIV vaccine offers the greatest promise for reducing global rates of HIV infection and reversing the devastating social and economic costs and development inequalities that have been exacerbated by HIV/AIDS. Historically, vaccines have proven to be one of the most cost-effective public health interventions for controlling the spread of infectious diseases. More than 30 common infectious diseases are now preventable with vaccines, including polio, measles, mumps and whooping cough. A vaccine for HIV could substantially alter the course of the AIDS epidemic; prevent untold personal suffering; and save millions of lives and billions of dollars in health care and associated costs.

How long will it be before the world gets an HIV vaccine?

A safe and effective HIV vaccine may not be available for another decade. Although significant work has been undertaken in Canada and worldwide to develop an HIV vaccine, none has yet been proven to effectively protect against infection. Several clinical trials of promising vaccine candidates are currently underway, but there are significant scientific obstacles to developing and delivering HIV vaccines that can only be overcome through long-term, focussed and globally coordinated action.

Many scientists believe that even when a safe vaccine is licenced for use globally, it may not provide complete protection against HIV infection. A “first generation” HIV vaccine may only delay progression of the disease for those who have been vaccinated, however, they could still become infected with HIV later on. Nevertheless, such a vaccine could slow the progression of HIV and provide scientific evidence to support the development of more effective vaccine candidates.

How much will an HIV vaccine cost, and who can afford it?

The many scientific challenges inherent in developing and delivering an HIV vaccine make it a costly endeavour. In 2006, the world invested approximately $933 million to develop and test HIV vaccine candidates and to carry out the policy and advocacy work to lay the foundation for their development and introduction. Sustained and significant global investments will be required in the coming years to achieve the goal of safe and effective HIV vaccines and may result in expenses that are higher than costs to develop vaccines for other diseases.

Consequently, one of the aims of the CHVI is to support the principles of global access by striving to ensure that benefits derived from the initiative are relevant and accessible to all, especially those in LMICs where the burden of HIV/AIDS is the highest and the needs are the greatest. Canada’s position is that HIV vaccines must not only be safe and effective, but must also be affordable and globally accessible.

Why is it important to conduct HIV vaccine trials in LMICs and diverse population groups?

HIV/AIDS is a disease that knows no boundaries – geographic, socio-economic, gender, age or otherwise. The burden of the disease is greatest in LMICs, particularly in sub-Saharan Africa and in the Caribbean, East Asia, Eastern Europe and Central Asia. It is also particularly entrenched amongst vulnerable groups in society, such as the homeless; indigenous peoples; people who inject drugs; the mentally ill and other disabled persons; commercial sex workers; men who have sex with men; prisoners and persons in detention; and migrant workers – people who are isolated from family and support networks; and those whose gender, sexual orientation, culture or personal circumstances make them dependent on, and vulnerable to others.

Involving at-risk populations in clinical trials is the most efficient and effective way to assess whether a candidate vaccine will work and will be acceptable to diverse population groups. There are different strains of HIV, and it is not yet clear whether a vaccine that protects against one strain will be effective in protecting against others. This means that trials must be conducted not only in developing countries (over 90 percent of people living with HIV/AIDS are in the developing world), but also in different parts of the world amongst people of different genders, races and cultures. Engaging at-risk populations in clinical trials also ensures that related benefits, such as harm-reduction counselling and other services, reach those most in need.

The CHVI represents a significant Canadian contribution to global efforts to ensure that the ultimate benefit of HIV vaccine research and development that an HIV vaccine is made readily available at reasonable prices and in sufficient quantities to those who are most in need but can least afford it. To that end, the needs of developing countries are at the core of the CHVI.

Where are trials happening around the world?

According to the AIDS Vaccine Advocacy Coalition, more than 30 clinical trials of experimental HIV vaccines were underway in 2007. The trials are taking place in over 20 countries around the world, including Canada.

• The vast majority of trials are in Phase I. These trials typically involve fewer than 100 volunteers and are used to determine the safety of the candidate vaccine.
• Two test-of-concept trials (Phase IIb trials) have been halted because the vaccine did not indicate that it could prevent HIV infection or that it could affect the course of the disease in those who became infected.
• Only one of these trials, involving 16,000 people in Thailand, had advanced to Phase III, the final stage before obtaining regulatory approval for an experimental product. Phase III trials can take several years and involve thousands of volunteers from high-risk populations. For more information please visit: http://content.nejm.org/cgi/
  content/full/NEJMoa0908492v4

For an up-to-date listing of trials around the world, visit the AIDS Vaccine Clearinghouse website at http://www.aidsvaccineclearinghouse.org.

Why is community involvement so important to HIV vaccine development?

Community involvement is essential to the development of HIV vaccines. People from vulnerable communities not only volunteer for clinical trials, but also play a key role in designing trials that would be acceptable to their communities. The engagement of communities lends credibility for the study and fosters public and government support for vaccine research. It also helps ensure community acceptance of vaccines, once they are discovered.

What is the Global HIV Vaccine Enterprise?

The Global HIV Vaccine Enterprise is an alliance of independent organizations around the world dedicated to accelerating the development of a preventive HIV vaccine based on a shared Scientific Strategic Plan (SSP). The SSP envisages implementation of a strategic plan for HIV vaccine research that spans vaccine discovery; product development and manufacturing; and clinical trials. It also envisages increased resources by mobilizing significant new funding to achieve the scientific plan; and greater collaboration by promoting more efficient, faster ways for researchers to share successes and failures and avoid duplication of efforts.

Canadian HIV Vaccine Initiative

What is the Memorandum of Understanding (MOU) between the Government of Canada and the Bill & Melinda Gates Foundation on HIV Vaccines?

The MOU formalizes a collaboration between the Government of Canada and the Bill & Melinda Gates Foundation to further strengthen global efforts to accelerate the development of HIV vaccines and to contribute to the achievement of the Global HIV Vaccine Enterprise’s Scientific Strategic Plan.

Over the next five years, the Government of Canada and the Gates Foundation will contribute up to $111 million and $28 million (CAN) respectively towards the collaboration. The Gates Foundation has indicated its readiness to contribute additional funds up to $40 million US should Canada increase its contribution.

What is the Canadian HIV Vaccine Initiative?

The CHVI represents a collaborative Canadian contribution to the Global HIV Vaccine Enterprise that is dedicated to accelerating worldwide efforts towards the development of safe, effective, affordable, and globally accessible HIV vaccines, that are essential to ultimately overcoming the HIV/AIDS epidemic. It builds on the Government of Canada’s long-term commitment to a comprehensive approach to fighting HIV/AIDS domestically and globally, including the development of new HIV prevention technologies.

Collaborating departments and agencies include the Canadian International Development Agency, the Public Health Agency of Canada, Industry Canada, the Canadian Institutes of Health Research, Health Canada, and the Bill & Melinda Gates Foundation. The Government of Canada is contributing up to $111 million and the Gates Foundation is contributing up to $28 million over five years.

The CHVI will be an inclusive, global collaboration involving developed and developing countries, researchers, non-governmental organizations, the private sector and governments.

In December 2009, the Government of Canada & the Bill and Melinda Gates Foundation decided not to move forward with establishing a pilot scale manufacturing facility for HIV vaccines.  Other program areas of the CHVI are unaffected by this decision, and the Government of Canada and the Bill & Melinda Gates Foundation are exploring other areas of investments to accelerate the delivery of safe, effective, affordable, and accessible HIV vaccines.  As a result, CHVI goals, priority areas, funding opportunities will be revised over the next few months.  For more information, please click here.

How was the Canadian HIV Vaccine Initiative developed?

The CHVI was developed collaboratively by the Canadian International Development Agency, the Public Health Agency of Canada, Industry Canada, the Canadian Institutes of Health Research, and Health Canada, in partnership with the Bill & Melinda Gates Foundation.

The CHVI builds on discussions held in 2005, when leading Canadian researchers, private sector and governmental representatives met with representatives of the Gates Foundation to explore potential areas for a Canadian contribution towards the Global HIV Vaccine Enterprise.

The CHVI is closely aligned with the goals of the Federal Initiative to Address HIV/AIDS in Canada that include preventing the acquisition and transmission of new HIV infections in Canada and contributing to global efforts to reduce the spread of HIV and thereby mitigate the impact of the disease. The CHVI’s approach is also aligned with CIDA’s support of research-based solutions aimed at addressing the health needs of developing countries. It represents the federal government’s response to The Canadian HIV Vaccines Plan.

The CHVI complements other recent Government of Canada activities in vaccine development, including support to the International AIDS Vaccine Initiative (IAVI) and the African AIDS Vaccine Programme (AAVP) ; and investments in the National Microbiology Laboratory to strengthen vaccine discovery research and the University of Saskatchewan’s International Vaccine Centre.

How is the Canadian HIV Vaccine Initiative managed and coordinated? Which Minister is responsible for its implementation?

The Minister of International Cooperation, the Minister of Health and the Minister of Industry collaborate on the implementation of the CHVI, with the Minister of Health leading its overall coordination.

The Ministers are supported by an Interdepartmental Steering Committee, composed of senior officials from the Canadian International Development Agency, the Public Health Agency of Canada, Industry Canada, the Canadian Institutes of Health Research, and Health Canada, who provide oversight and strategic direction.

A committee with representatives from international stakeholders, the private sector, researchers, people living with HIV/AIDS, governments, researchers and NGOs, as well as other relevant stakeholders, will also be created to advise the Steering Committee on domestic and international issues related to HIV vaccines.

A CHVI Secretariat, housed in the Public Health Agency of Canada, will assist the Steering Committee in achieving its mandate. The secretariat (secretariat@chvi-icvv.gc.ca) will work with participating departments and agencies, the Bill & Melinda Gates Foundation and other collaborators to provide operational support, including planning, monitoring, reporting and evaluation.

How does the Canadian HIV Vaccine Initiative relate to other Government of Canada HIV/AIDS activities?

The CHVI is designed to build on key strengths and investments made by the Government of Canada and to mobilize partnerships and expertise in Canada and in LMICs. The CHVI increases total Government of Canada investment in HIV/AIDS and it further enhances HIV vaccine activity in Canada and LMICs through a partnership with the Bill & Melinda Gates Foundation.

The CHVI is closely aligned with the goals of the Federal Initiative to Address HIV/AIDS in Canada that include preventing the acquisition and transmission of new HIV infections in Canada and contributing to global efforts to reduce the spread of HIV and there by mitigate the impact of the disease. It complements HIV/AIDS activities undertaken and supported by the Public Health Agency of Canada, the Canadian Institutes of Health Research, Health Canada and Correctional Service Canada under the Federal Initiative, including HIV vaccine-related research and the development of the Canadian Vaccines Plan.

The CHVI also complements the Canadian International Development Agency’s support to the Global Fund to Fight AIDS , Tuberclosis and Malaria , The Joint United Nations Programme on HIV/AIDS (UNAIDS), World Health Organization (WHO) and the International Partnership for Microbicides in the global fight against HIV/AIDS, in general, as well as its support to international HIV vaccine research and development through the International AIDS Vaccine Initiative and the African AIDS Vaccine Programme .

How does the Canadian HIV Vaccine Initiative benefit Canada and developing countries?

The CHVI will raise Canada’s profile, while contributing to global HIV vaccine discovery efforts, and facilitating easy access to the results of HIV vaccine research and development. The research could results in the discovery of an HIV vaccine that could be obtained at a reasonable price and in sufficient quantities to those who are most in need of the vaccine, but can least afford it, particularly in developing countries. An HIV vaccine will also benefit Canadians at risk from the virus.

The CHVI will significantly contribute to the strengthening of capacity for HIV vaccine research and development, including strengthened capacity to perform discovery and social research in LMICs.

The CHVI will also advance Canada as a centre for biomedical innovation and manufacturing and health sciences research; will provide a facility for responding to public health challenges; and will create a business environment that will help Canadian public and private sector researchers move from research and development to commercializing vaccines for global use.

What will happen to the Canadian HIV Vaccine Initiative in five years?

Funding for the CHVI has been dedicated for a five-year period ending March 2012. Decisions on extending the CHVI will be taken by the Government of Canada following the completion of a five-year evaluation, which will be led by the Public Health Agency of Canada, in collaboration with participating departments and agencies, as well as the Bill & Melinda Gates Foundation.