Vaccine Satellite: Looking at the Big Picture

By Patricia Kahn, Ph.D.*

For the first time since the International AIDS Conferences began in 1983, this year’s event featured an official satellite meeting on vaccines.

“AIDS Vaccines for the World: Working Together to Accelerate Development and Delivery,”* attracted over 375 people from 61 countries and a wide range of sectors, reflecting the diversity of conference participants. The agenda mirrored this breadth, with presentations on progress—as well as the gaps and challenges ahead—from the scientific, political and community perspectives.

The Bottom Line: Political Commitment

The need for greater political support of vaccine development was one of the most frequently-raised themes, underscoring its key role in virtually all stages of the vaccine effort.

That tone was set in the meeting’s first presentation, given by Kapil Sibal, Member of Parliament in India. Sibal belongs to a bipartisan group of Parliamentarians working to draft legislation supporting a comprehensive national response to HIV/AIDS, establish the necessary financial mechanisms and build a supportive, rather than punitive, legal framework that protects human rights and combats stigma. “If we don’t do something, we’ll have an epidemic [like sub-Saharan Africa’s] on our hands,” he said.

Paolo Teixeira, director of Brazil’s National STD/AIDS Programme in the Ministry of Health, described the infrastructure supporting the country’s widely-hailed response to the epidemic, and that now provides a foundation for vaccine trials—from nation-wide health care clinics and diagnostic labs to surveillance and ARV distribution networks. Brazil also has many active AIDS NGO’s, a robust research community and a national vaccine plan.

Early commitment and a national vaccine plan were also key factors in enabling Uganda to host Africa’s first AIDS vaccine trial (in 1999-2001), according to David Apuuli, Director-General of the Ugandan AIDS Commission. With this experience in hand, as well as clinical trials infrastructure and trained personnel, the country has now revised its vaccine plan to further define procedures and standards for trials and to help prepare for future access. Still needed, said Apuuli, are more international partnerships and funding to expand vaccine activities.

While national vaccine plans are becoming increasingly common in the developing world, the Canadian government’s announcement just prior to Barcelona that it will prepare a vaccine strategy makes it the first industrialized country to do so.

Even in the scientific sessions, political commitment was a frequent theme. For example, VaxGen president Don Francis criticized the widespread “can’t do” attitude towards AIDS vaccines in politics and media, and the lack of social value placed on vaccines. “If the world really cared, we’d have more candidates,” he said. While the cost of making and testing vaccines is high (VaxGen’s product has cost US$200 million), Francis pointed out that this is a small fraction of the $18 billion spent annually in the US on AIDS treatment and care.

Advocacy: “Principled Leadership and Angry Activism”

Addressing the need to increase political commitment, several speakers spelled out some concrete steps. David Patterson of the Canadian HIV/AIDS Legal Network (which held a satellite meeting the previous day; seewww.aidslaw.ca), urged greater links between vaccine and treatment advocates, emphasizing their common issues—such as community mobilization, concerns about HIV testing and stigma, clinical trials infrastructure, financing and regulatory structures, and—in the industrialized world—overcoming complacency. To succeed, he said, “we need principled leadership…and angry activism.”

Illustrating an advocacy movement built from these links, Jorge Beloqui of Brazil (Grupo de Incentivo à Vida, Sao Paulo) described how Brazil’s AIDS NGOs and community groups became involved with vaccines early on, and how advocates and general AIDS outreach programs are incorporating vaccine issues into their ongoing work.

Communities: Moving Towards Fuller Partnerships

With more vaccine trials on the horizon, several speakers emphasized that outreach efforts should focus not only on potential trial volunteers but on engaging the broader community.

This need was underscored by Emmanuel Mugisha of the Ugandan Virus Research Institute (and community development coordinator for the IAVI/Ugandan vaccine partnership), who described recent studies on local knowledge and perceptions of AIDS vaccines. Despite many years of public awareness campaigns around HIV/AIDS, the studies detected many stigmatizing attitudes. For example, focus groups with students, religious groups, police and workers in hospitals and industry revealed beliefs that vaccines would make people more promiscuous, and that trial participants are somehow “not normal.”

Others addressed the role of Community Advisory Boards (CABs) in expanding outreach. Winnie Serobe, nurse and vaccine CAB member at the Perinatal HIV Research Unit in Soweto, South Africa, pointed out that this CAB was started by the “Gogos” (elderly people), who will not be trial participants. Steve Wakefield of the HIV Vaccine Trials Network (HVTN) emphasized that supporting CABs as they build capacity, and intensifying community preparedness overall, is an iterative process. “This is an intense learning experience, and in most cases the answers to the problems and challenges are being discovered as the work develops,” he said.

There was also broad agreement with advocates’ call to engage people already involved in AIDS work, as well as HIV-positive communities. “Not many people have done vaccine trials, but many have AIDS experience,” said Chris Beyrer of Johns Hopkins University and the HVTN. Paisan Tan-Ud, former chair of the Thai Network of People Living with HIV/AIDS, drove home this point, saying that even in a country as deeply involved with vaccines as Thailand, the effort is poorly connected to AIDS NGO’s and HIV-positive groups. He also pointed out the glaring discrepancy in Thailand’s successful prevention efforts to reduce sexual transmission, and the paucity of programs geared towards injecting drug users—not only in Thailand but throughout Asia and Central Europe—and called on the vaccine community to help close this gap.

The Big Science Questions

Alongside overviews of candidates and research programs, the meeting highlighted some key issues in vaccine R&D. In the near-term, these include:

optimizing designs for T-cell based vaccines;
resolving hurdles to making vaccines that elicit broad neutralizing antibodies;
standardizing immune assays so that results from different studies can be more readily compared;
determining whether any candidates now in the pipeline offer any protection;
choosing the best trial endpoints and establishing what will be licensable.

Looking more broadly, the field is continuing to search for immune correlates of protection, and to understand the role of mucosal immunity and the importance of clades.

In a concluding panel discussion, Jaap Goudsmit (Crucell N.V.) criticized the proliferation of “me-too” candidates in the pipeline, while Science magazine correspondent Jon Cohen questioned whether the field is doing all the right things, or needs to expand (not only speed up) its activities—which is what would happen “if 20% of the US population were infected,” he said.

Gearing Up for Efficacy Trials

Besides issues of trial endpoints (see also Barcelona Sessions Spark Full Discussion of Partially Effective Vaccines), several other speakers addressed the challenges of building capacity for Phase III trials. Tim Mastro (CDC, Atlanta) and Glenda Gray (PRHU, Soweto) each described how rapid changes in HIV incidence complicates the task of establishing large cohorts—a process that usually takes years. Gray also raised the sensitive issue of including adolescents in trials—a move that makes sense in terms of their high risk but raises other issues, such as obtaining informed consent while maintaining confidentiality.

Getting Access and Manufacturing Issues On the Table

IAVI president Seth Berkley discussed the challenge of convincing people that manufacturing issues need to be tackled now. “It’s been said that if you create a pot of gold, this will take care of itself,” he said. “This is clearly not true.” Berkley called for more work on scaling up key new vaccine technologies, to avoid delays once a vaccine is found.

Geeta Rao Gupta, president of the International Center for Research on Women (Washington, DC) raised another issue in facilitating rapid access to vaccines: the need for community-based research on factors that will influence its acceptability. In the case of drugs that reduce mother-to-child transmission, she said, researchers failed to consider stigma and womens’ fear of testing positive, which have led to low uptake in some regions of the world.

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*Patricia Kahn, Ph.D., is editor of the IAVI Report.