Hester Kuipers 

In the last two editions, Global Medicine in collaboration with the International Aids Vaccine Initiative (IAVI) paid special attention to the development of an HIV/AIDS vaccine. In this last episode IAVI will explain more about their research in developing countries.  

 

Read her the first episodes from IAVIs series on the search for an HIV/AIDS vaccine.

Read here the second episode on the quest for an AIDS vaccine: a scientific perspective.

 

In the 28 years since scientists identified the human immunodeficiency virus (HIV) as the cause of AIDS, it has spread relentlessly, causing one of the most devastating pandemics ever recorded in human history. The majority of the people infected with HIV are living in the developing world and less than one third of those have access to the treatment they need.

There is, clearly, an urgent need for new tools and technologies to protect people from contracting HIV in the first place, especially for the strains that predominate in developing countries. Nothing is likely to do quite as much in this regard as an AIDS vaccine. But any such vaccine needs to be developed in the countries hardest hit by the pandemic, where its efficacy can be measured against the varieties of HIV that cause the greatest number of infections. This is why the IAVI, in collaboration with regional governments and researchers, has invested in building research capacity in regions as Africa and Asia. Over the years IAVI has established a network of world class research centres in these regions to conduct clinical trials of candidate HIV vaccines. Till now IAVI has put six new experimental vaccines to the test in human trials. In this article IAVI will explain more about ethical human research in developing countries.  

The people factor

None of this research can be conducted without the support of the local communities from which volunteers are drawn and which is only possible if people trust the researchers working in their midst. That trust has to be earned, especially if the research is related to AIDS, which remains a source of stigma and a flashpoint of controversy across much of the world today. Aware of this, IAVI and its partners take a comprehensive public health and development-focused approach to AIDS vaccine research. The policies that guide the activities in every country uniformly emphasize thoughtful attention to the needs of both study volunteers and the communities in which they reside.

Before enrolling volunteers, research teams ensure that they have freely given informed consent on the basis of a clear understanding of the risks and benefits of participating in the study, and that they are aware of their right to drop out at any time. Volunteers are continually asked by research staff to reaffirm their consent verbally over the entire course of the study. Research teams must also get approval for the study protocols - and the informed consent procedures and materials used for volunteer education - from local institutional ethics committees and other regulatory agencies.

IAVI and collaborators also work to ensure that volunteers receive adequate healthcare.  Of particular concern in this regard is the voluntary HIV counselling and testing (VCT) that is provided to all volunteers in HIV-related research. Trained counsellors conduct VCT in a confidential setting and in a manner that respects the typically diverse backgrounds of volunteers. Women may also receive detailed family planning counselling during the trial, including access to contraception. If volunteers test positive for HIV during the clinical study (it should be noted that it is impossible for candidate AIDS vaccines to cause HIV infection and that VCT and risk reduction counselling generally reduces the risk of acquiring HIV in clinical trial volunteers), the counselling includes help in identifying sources of social support, discussing disclosure and other immediate concerns, creating a risk reduction plan, discussing medical follow-up, and referrals to appropriate treatment and support organizations.

In collaboration with research partners and NGOs, IAVI has also introduced a gender sensitization programme, the first of which was developed in India. This matters because it is difficult to recruit and retain women in HIV vaccine trials, and candidate vaccines need to be tested in women as well as men to ensure they are safe and effective for both sexes. It also matters because women and girls particularly need prevention tools over which they have complete control (which is often not the case for condoms or male circumcision). Similarly, close attention is paid to the needs of vulnerable groups that are at high risk of HIV infection and that would especially benefit from access to a future AIDS vaccine. This includes developing strategies for working with commercial sex workers and men who have sex with men to support their participation in HIV–related research while limiting the risk of stigma and discrimination caused by this participation.  

The benefits of building capacity

Support for the establishment of a research network in sub-Saharan Africa has had an invaluable impact on the region. It has, for one thing, expanded capacity for clinical trials to take place in a region that had until then played only a minor role in the development of new vaccines (an effort that has traditionally been done largely in the US and Europe). Aside from its obvious contributions to the global campaign against AIDS, such research is also changing how African scientists work, expanding their professional horizons and seeding a regional scientific community that can now begin to find solutions to the countless public health challenges facing sub-Saharan Africa. Experienced scientists and technicians are making their presence felt in these places in more ways than one. The Uganda Virus Research Institute, a partner of IAVI, runs a research mentoring programme that enables junior clinical trial managers and lab scientists to work alongside more experienced teams. Scientists from government-sponsored research programmes in Kenya, Tanzania and Malawi have been mentored by the Ugandan coordinators in areas as designing and managing clinical trials and complying with Good Clinical and Laboratory Practice.

Building and sustaining research capacity may also pave the way for access to and uptake of a future AIDS vaccine in developing countries. Engaging healthcare workers and counsellors, community outreach workers and communities themselves in research builds critical experience that will likely increase acceptance of future AIDS vaccines, and support their distribution. This matters because, historically, vaccines introduced in the West have taken up to 25 years to become widely available and utilized in developing countries. This, of course, is unacceptable. So developing systems to ensure the future delivery and uptake of AIDS vaccines—including everything from regulatory and health care infrastructure to public awareness and education—is almost as important as developing the vaccine itself.  After all, as the legendary vaccinologist Albert Sabin once observed, a vaccine that sits on the shelf is of no use to anyone.  

Further reading

• Read here the first episode from this series on IAVIs search for an AIDS vaccine, published in Global Medicine 6.
• Read here the second episode from this series on the development of an HIV/AIDS vaccine, published in Global Medicine 7.
• IAVI online resources
  • Clinical Guidance: Essential Approaches for the Conduct of IAVI Clinical Research.
  • A boost for African science.
  • The Journey Towards An AIDS Vaccine: Perspectives on Conducting Trials in Developing Countries.

 

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