IAVI Report - March / April 2002
Emily Bass

On June 3-4, scientists, policy-makers, global health experts and other participants in the vaccine trials arena will gather in Cape Town, South Africa, for an international forum on the African AIDS Vaccine Programme (AAVP). The meeting will be an expanded debut for the AAVP, which has maintained a low profile since its inception in 2000. Planners hope that the gathering, which is co-sponsored by many international stakeholders in vaccines, will take the program to the global stage, with substantially expanded funding and political buy-in to support AAVP.

It's a timely move. Trials and preparations are percolating at many African sites, notably in Uganda and Kenya, which have already garnered some Phase I trial experience, and South Africa, which is now considering its first protocols. And even as scientists and communities navigate the regulatory, ethical and media mazes surrounding these small studies, they're sizing up bigger challenges: preparing for large-scale trials and eventual delivery of a licensed vaccine.

As plans for scale-up proceed, African scientists are looking to supplement the bilateral international partnerships which already abound on the continent. "In the past we [African vaccine researchers] have worked in isolation from each other," says Pontiano Kaleebu, principal investigator at the Uganda Virus Research Institute and a member of the AAVP Biomedical Sciences committee. "This must begin to change."

This move towards pan-African collaboration brings challenges: Is consensus across borders needed on issues like ethics guidelines, standards of treatment and care in vaccine trials, or strategies for testing vaccines against different HIV subtypes? Where can individual countries and stakeholders afford to go their own ways? How will AAVP leaders who already collaborate with international partners balance continent-wide goals with partnership-driven concerns? And how can countries which do not host trials—but have serious epidemics and therefore a stake in finding a vaccine—contribute to the overall effort?

As AAVP attempts to grapple with these issues on a continental scale, it has set itself the tall task of involving every country, spanning the broad spectrum of capacity, stability and wealth that defines Africa today. "The principle of AAVP is that every African country should be involved [in AIDS vaccines]," says José Esparza, head of the WHO/UNAIDS HIV Vaccine Initiative, which helped launch the AAVP in 2000 and provided US$ 1 million in start-up funds. "We should not encourage every country to do vaccine trials. But vaccine preparedness? Yes."

AAVP began with research and education: creating inventories of existing ethics documents, organizing workshops for researchers to discuss good clinical practices or learn key laboratory techniques, and collating information on the preparation of national vaccine plans. This set of activities has helped AAVP get its feet wet for the hybrid role it hopes to play as participant-advocate-advisor—not funding trials or stocking the pipeline, but helping to build infrastructure and representing African scientists in discussions of these efforts.

To this end, the Programme is prioritizing capacity-building for trials, and training researchers and clinicians—activities that will supplement work already being done. "AAVP is not going to reinvent the wheel," says Malegapuru William Makgoba, chair of the AAVP steering committee and head of South Africa's Medical Research Council (MRC). "It will spin the wheel that is already rotating. We need to accelerate and support efforts already coming from different parts of the world."

To play this role, AAVP needs to build strong relationships with the world's vaccine stakeholders. That's where the June meeting will be crucial: AAVP will present its progress so far and its future agenda, and then spell out the resources needed to achieve it. The draft plan calls for US$ 5-6 million a year for AAVP core activities. Adding in funds to catalyze African vaccine work on a larger scale—including preparedness activities, clinical trials site development and staff training—the total comes to roughly US$ 230 million over the next seven years, according to Esparza. And he stresses that AAVP need not receive these funds directly: much of it could go through existing bilateral partnerships that can help AAVP meet its strategic milestones.

"We will do what is not being done by others," says Kaleebu. "We can share national vaccine plans and trial plans with countries that want to get involved. That will help a lot. But we still need money."

AAVP's move to become a catalytic force in Africa takes place against a dynamic backdrop in which AIDS is receiving increasing attention as a development issue (see article, "World Economic Forum Discusses Global AIDS Vaccine Delivery "), and new mechanisms like the Global Fund to Fight AIDS, Tuberculosis and Malaria are funneling money into developing countries.

Whether or not the AAVP succeeds with this and the other considerable challenges it faces, scientists say that it has already set an important precedent. "Africans have never had this kind of forum," says Makgoba. "The only time we learned what was happening was when we met in Geneva or in Japan. We never met amongst ourselves in Africa to say, ‘These are our priorities. These are the challenges we face. If you want to help us, help us this way.'"

Filling a Need
AAVP was born in Nairobi, Kenya at a meeting in June 2000, shortly before the 13th International AIDS Conference in Durban. At that first meeting, Africa's leading AIDS vaccine researchers signed the "Nairobi Declaration," which called on African leaders to make AIDS vaccine development a top priority, laid out a timeline and framework for activities, and increased public education and political lobbying on the importance of vaccines.

Until now, AAVP has focused on laying a foundation for its global efforts through behind-the-scenes activities, and has not yet sought a vocal role in African advocacy. "We, as stakeholders, have not come out together explicitly for AAVP [as the] voice for Africa," notes William Makhema, senior specialist of the Botswana-Harvard Partnership and the Princess Marina Hospital, an expansion site in the US-sponsored HIV Vaccine Trials Network (HVTN).

But much has happened in the past two years, with an array of international research teams and African partners now conducting or preparing for vaccine trials. In this context, many on the continent are looking to groups such as AAVP to articulate a widespread concern that in-country efforts should spill over to the continent as a whole. "We don't want a situation where, simply because the population participating in the research was in Botswana or Uganda, they are the sole beneficiaries," says Makhema.

Laying Out an Ambitious Plan
At the June meeting, AAVP will present the work plan of its steering committee and five working groups: Advocacy and Resource Mobilization; Biomedical Sciences; Population-Based Studies; Ethics, Law and Human Rights; and National Strategic Planning.

In 2001-2002, just under half the AAVP budget went to the Biomedical Sciences group, which aims to identify areas for research collaborations and help build capacity for regional reference centers which can characterize HIV isolates and immune responses. That, in turn, is based on a now-completed inventory of labs and trained personnel, and on the ongoing program of lab training courses co-sponsored by WHO/UNAIDS.

After Biomedical Sciences, the Ethics, Law and Human Rights (ELH) group is farthest along in its activities, says Esparza. This group, which works closely with the ethics committee of the South African AIDS Vaccine Initiative (SAAVI), has conducted an inventory of ethics resources (such as guidelines for clinical research) in African countries, which it is collecting into a central clearinghouse. The results of a "Symposium and Networking Forum on Ethics, Law and Human Rights" held in Durban at the end of April will be presented at the Cape Town meeting in June.

The remaining AAVP groups are still laying out their agendas. Population-Based Studies hopes to serve as a match-maker between groups developing vaccine candidates and those working with local populations. The National Strategic Planning Committee will support country efforts to develop national AIDS vaccine plans, and the Advocacy group will focus on fundraising and media outreach.

So far, AAVP has collated the information gathered in these different groups into "country profiles" that outline the capacity, readiness and epidemiology of AIDS in different countries. The hope is that such information will help donor countries and research institutions make educated choices about how to get involved.

Building Capacity, Expanding Training
AAVP's roster of members is a Who's Who of African AIDS researchers. But as robust as this group is, its members are quick to point out that one of the most serious challenges their countries face in doing research or preparedness work is the serious shortfall in trained personnel—stemming from poor resources and infrastructure for training and from the political instability and lack of opportunity that drives trained young people to work abroad.

Last November, this plight was presented in stark relief during a talk in Botswana at a Harvard AIDS Institute "think tank" meeting on developing vaccine trials networks in Africa. Zimbabwean scientist Stephen Chandiwana, director of the Blair Research Institute in Harare, showed a slide of a solar eclipse, with the sun gone dark. Standing before this arresting image, he spoke about the flight of trained young doctors and nurses personnel out of the country, which has been rocked by political unrest in recent years. Chandiwana says that he pleads with his medical students to remain in the country, telling them, "If science can survive at this lowest ebb in history, the future may be positive."

AAVP hopes to help address the need for highly skilled local personnel by boosting the capacity of African universities to train MSc, PhD and post-doctoral candidates in vaccine science. In the short term, it will continue the established series of "wet workshops" and training courses offered with WHO/UNAIDS. These activities will enhance training from various bilateral partnerships around HIV and vaccines.

Such training is one of AAVP's strategic milestones, Esparza says, and one where he hopes that other collaborators will step in. One new player: the US HIV Vaccine Trials Network (HVTN), which recently appointed a coordinator to develop teaching materials for ten key areas, including HIV vaccinology, community advisory boards (CABs) and data management—a curriculum that could evolve into an accreditation process. At Johns Hopkins University, Karen Charron and Don Burke have developed an Internet-based course ("Clinical Vaccine Trials: Planning and Implementation") given during the academic semester and drawing students from around the globe. Recently, it went on the road as a 3-day, hands-on workshop in Nairobi for staff of the Phase I vaccine trial co-sponsored by IAVI, the Kenyan AIDS Vaccine Initiative and the UK Medical Research Council; soon it goes to HVTN sites in Durban and Johannesburg.

Yet another capacity issue that AAVP will face comes from the growing needs around licensing and regulatory mechanisms. (see interview, "Licensing an AIDS Vaccine in Developing Countries"). And a group like AAVP has a role to play by emphasizing the importance of the issue, advocating for resources and referring personnel to relevant trainings.

Seizing Opportunities for Change
Despite these gaps, there's reason for optimism on the political front: The move towards pan-African vaccine advocacy comes at a time of unprecedented regional collaboration on the continent. Integration was the watchword at the third African Development Forum in Addis Ababa this March, and is a guiding principle for the Organization of African Unity (soon to be renamed the African Union.) "The general trend in Africa is for countries to work together much more than they used to," says Gayle Smith, former senior advisor on Africa to the Clinton administration and an advisor to IAVI.

AAVP hopes to become a powerful and familiar presence in these networks. "We have to talk with African heads of state about the need to work together," says Uganda's Kaleebu. "We need a group doing advocacy with the South African Development Community (SADC), the OAU, and other groups. Their political commitment is necessary."

Whoever takes the helm of the newly formed African Union—South African president Thabo Mbeki has been touted as a likely candidate—will face the fact that AIDS is what Smith calls "one of five number one priorities" for Africa. Debt, war, TB, malaria and endemic poverty rank high on African political agendas and are inextricably linked to the several of the epidemic Even here, though, there are reasons for optimism. Smith suggests that a regional or continental vaccine initiative might lobby for economy-boosting activities, such as in-country manufacture of vaccines. It might also explore conflict-resolution strategies--even temporary ones--that would allow vaccinations to take place within war zones. "AIDS is the best opportunity for structural change in Africa in ten to fifteen years."  •

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