Global advocacy for HIV vaccine research

Which organisations are currently working on global HIV vaccine advocacy?

IAVI (www.iavi.org) was set up in 1995 in the USA as a non-governmental organisation sponsored by various US foundations and donors.

IAVI was founded out of a judgement that the global effort towards a preventive vaccine was in trouble, following a 1994 decision not to proceed with US efficacy trials for gp120 vaccines. It has lobbied the US government, other G8 countries and intergovernmental organisations including the World Bank and UN agencies. It has equally sought to engage with corporations and community organisations, with formal partnerships agreed between IAVI and agencies in a number of countries including the UK’s National AIDS Trust.

One key idea that it has promoted is the creation of a guaranteed and credible market for vaccines, by securing the promise of major loans to buy any proven vaccine on behalf of the governments of countries that are in the greatest need. Such loans could be repaid from future savings on humanitarian aid and need not add to the debts of the countries worst affected by HIV.

IAVI funds research specifically directed at vaccines which would be appropriate for countries where the need is greatest and the resources most limited.

Since its founding, IAVI has worked with more than50 academic, commercial and government institutions to develop and assess candidate HIV vaccines. In those 15 years, IAVI and its network of partners have translated innovative technologies into 17 vaccine candidates, nine of which have entered human trials in 11 countries.

IAVI has promoted the development of three consortia of researchers which are concentrating on specific questions in the basic science of vaccine design: the Neutralising Antibody Consortium, the HIV Live-attenuated Consortium, and the Vector Consortium.

IAVI is involved in helping countries build capacity to conduct or collaborate on vaccine trials. It assists with the convening of Community Advisory Boards, which represent the communities in which clinical trials are conducted and which help design trial protocols. Moreover it educates people about vaccine trials and the need for AIDS vaccines.

IAVI publishes a scientific newsletter, IAVI Report, and makes its publications freely available through its website.

The GHVE (www.hivvaccineenterprise.org) was set up in 2004 after a position paper in Science journal argued that an AIDS vaccine is one of the most difficult challenges facing biomedical science today, and while important progress has been made, there is a critical limitation in the way vaccine research and development is usually conducted.

Research is usually undertaken by small groups of investigators - academic laboratories and biotechnology companies - who typically operate independently of each other, and the scale of their projects is often too small to adequately address major scientific questions. The pace of progress could be increased through greater cooperation and collaboration, and more funding targeted to large projects that tackle major questions.

The GHVE currently has 27 stakeholder member organisations, including pharmaceutical companies, governments, multilateral agencies, and non-governmental advocacy organisations. Members work to an agreed scientific plan (the last one was issued in 2010). They agree to reach consensus on scientific priorities, voluntarily divide responsibility for addressing the priorities and establish joint ventures that pool expertise, infrastructure and resources. They agree to iteratively apply each other’s advances so that the best science emerges as quickly as possible and unnecessary duplication is avoided.

Following the RV144 trial, GHVE issued a new scientific plan that called for a speeded-up effort to test new vaccine candidates in large trials.¹

The plan outlined two key priorities: firstly, better integration of the latest information from basic science and trials into new vaccine studies; and secondly, better use of information from preclinical studies and other areas of scientific research. GHVE is firmly in favour of more human studies as well as basic laboratory and animal research, saying that more trials in humans are needed if we are to answer the fundamental questions still puzzling vaccine researchers.

One example of the sort of question that needs to be answered is which immune system changes, after vaccination, correlate with protection against HIV, and whether these changes indicate a mechanism by which the immune system protects against HIV infection that can be exploited in future vaccine development.

In an interview with Aidsmap in September 2010,² GHVE Executive Director Alan Bernstein said that the vaccine research community needed “to go from one Phase IIb study every seven years to something like one every year, so that we have the opportunity to incorporate new findings into the design of studies.”

The GHVE calls this process “integrating iterative scientific enquiry with product development.” This means quickly incorporating new information from ongoing studies or failed studies into the design of new studies and trials that are just getting underway. It also means sharing data more quickly and testing a wider variety of vaccine approaches sooner in human efficacy trials.

AVAC (www.avac.org) is a community- and consumer-based organisation, founded in December 1995 to accelerate the ethical development and global delivery of vaccines against HIV/AIDS. It provides independent analysis, policy advocacy, public education and mobilisation to enhance AIDS vaccine research and development.

Since then AVAC has expanded into an organisation that, to quote from its website, “advocates for new prevention methods in HIV in general, not just vaccines. It uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.”

AVAC maintains an ongoing database of information on HIV prevention trials, research and development worldwide. It convenes meetings, seminars, conference calls and policy summits in order to facilitate communication and consensus between the various stakeholders in HIV prevention research and advocacy.

In 2005 AVAC published the second edition of the AIDS Vaccine Handbook, a comprehensive (404 page) introduction to AIDS vaccine science, ethics and community advocacy. It can be downloaded from www.avac.org/ht/a/GetDocumentAction/i/2634. The handbook covers:

• The basics of AIDS vaccine science.
• Clinical trials: being a volunteer; the ethics of trials, including making sure that trials leave communities better-off rather than worse-off; ensuring community participation and readiness; and how to work with trials that ‘fail’, as in the AIDSVAX trial.
• The experience and ethics of doing vaccine trials with different vulnerable communities.
• Global advocacy and political leadership.
• Personal accounts of involvement with trials.

AVAC has also set up a small-grants fund that will function as a small-scale “emergency fund” to assist clinical sites that require immediate help with purchases such as additional medical or laboratory supplies not covered by grants or contracts for vaccine research.

GAVI is not an HIV vaccine development organisation, but may become important if an effective vaccine is found. It was founded amid concern that existing financing mechanisms were not enabling vaccination programmes in the developing world to be sustained. Founded in 2000, it is a global alliance of governments in industrialised and developing countries, UNICEF, WHO, the World Bank, the Bill & Melinda Gates Foundation, non-governmental organisations, vaccine manufacturers from industrialised and developing countries, and public health and research institutions.

GAVI’s aim is to help strengthen health and immunisation systems in the developing world, accelerate access to selected vaccines and new vaccine technologies, especially vaccines that are new or underused, and improve injection safety.

GAVI provides multi-year grants to more than 70 of the world’s poorest countries to enable them to put on vaccination programmes, especially in children. In 2010, 72 countries with a per capita gross national income of less than or equal to US$1000 in 2003 were eligible for support.

In its 2010 progress report,³ GAVI provided a large amount of data on coverage of vaccines in different parts of the world, progress on pricing, efforts to secure sustainable funding, and policy developments to strengthen vaccine coverage and advocacy, not least by engaging civil society.

GAVI has been financed, directly or indirectly, by 17 governments to date – Australia, Canada, Denmark, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Russia, South Africa, South Korea, Spain, Sweden, the United Kingdom, and the United States. Finance has also come from the European Union, the Bill & Melinda Gates Foundation and a number of other private contributors.

It was announced in May 2011 that the new Chief Executive of GAVI would be Seth Berkley, the founder of IAVI.