Book 5: Context

South Africa is experiencing an HIV/AIDS epidemic. The development of a safe and effective HIV vaccine has been identified as an urgent health priority.

At the outset, it must be emphasised that HIV vaccine development should be understood and approached within the context of a broader national South African programme of HIV prevention - a programme that, at the time of for-mulating these guidelines, still requires considerably more definition, coher-ence and co-ordination. Evidence suggests that a successful vaccine may not be fully developed and operational within the first decade of the 21st century. In the meantime, the epidemic spreads and is clearly attaining catastrophic proportions. Without denying the eventual value or importance of a vaccine, the best way to fight HIV/AIDS remains prevention. Everything possible ought to be done to establish an effective and realisable national programme to prevent this epidemic reaching unmanageable and socially catastrophic dimensions. The South African government must be supported by civil society and the private sector to take a firm and unequivocal lead in the establishment of such a programme.

The individuals and communities who will participate in HIV vaccine development activities require not only an effective HIV vaccine, but also to have their rights and welfare promoted while participating as active partners. Complex biological and social factors associated with HIV affect the balance of risks and benefits for individuals and communities who participate in HIV vaccine development activities, and include the following:

1. The burden of disease and death related to HIV is increasing at a rate unmatched by any other pathogen. In South Africa, HIV is the leading cause of death in adults.
2. The context for access to effective treatment, antiretroviral medication, is transforming as drug prices are reduced, and regimens are simplified. However, antiretroviral medication is currently not readily available to the vast majority of people affected by HIV/AIDS in South Africa.
3. There is an ethical imperative to urgently seek effective and accessible vaccines for South Africa, in conjunction with other prevention strategies. The impact of even a partially effective HIV vaccine may be of great public health benefit.
4. Genetically distinct subtypes of HIV are predominant in different regions and countries, with subtype C being the most dominant subtype in South Africa. The relevance of subtypes to potential vaccine-induced protection is not clearly understood. Thus, it is not known whether a vaccine targeted at one subtype will protect against infection from another subtype. It is likely that a vaccine directed at a particular subtype must be tested in a population in which that subtype is prevalent. Thus, developing a vaccine for populations with the highest incidence of HIV is likely to require that the vaccine be tested in those populations. This is the case even though these populations may be relatively vulnerable to exploitation and harm. Testing of vaccines based on other subtypes may be appropriate to investigate important questions, such as cross-clade reactivity.
5. South African HIV vaccine development is likely to involve multiple partners. While the term 'sponsor' usually refers to the individual or institution that owns the candidate vaccine or funds the vaccine programme (typically a single corporate entity, such as a pharmaceutical company), in modern vaccine development there are multiple sponsors, including corporations, national governments and international agencies. Some candidate vaccines may be manufactured in laboratories of sponsor countries (usually developed countries) and tested in South Africa (a middle-income country with severe economic disparities, where the majority of the population are of low economic status). The potential imbalance of this situation demands that differing interests and capacities of sponsors and host should be addressed. South African health and research communities should be encouraged and enabled to make decisions regarding participation in HIV vaccine development, based on identified health priorities, in a context of equal collaboration with sponsors.
6. In South Africa those populations currently at highest risk of HIV infection are also vulnerable to potential harm and exploitation, due to a range of socio-historical reasons. Additional efforts are needed to overcome this vulnerability.
7. HIV/AIDS is a condition that is both highly feared and stigmatised, largely because it is associated with blood, sex, and illegal activities such as commercial sex. As these issues are difficult to address openly, people affected by HIV/AIDS in South Africa experience stigma, discrimination, and even violence. Vulnerability to HIV infection is greater where people are marginalised due to their social or legal status. These factors increase the risk of social and psychological harm for people participating in HIV vaccine trials. Additional efforts must be made to minimise these risks, and to ensure that risks are justified by the benefits. Meaningful community participation and authentic informed consent are critical safeguards.